Kyphosis

Scoliosis is a skeletal issue causing asymmetries, leading to functional disruptions. Common symptoms include uneven eye tilt, drop asloped shoulder, and muscle imbalances. These changes can affect the patient's physical appearance and psychological state. Current treatments have shown suboptimal results due to the lack of accepted scientific theories for idiopathic scoliosis. Therefore, a new therapeutic approach is needed to provide novel insights and improve treatment outcomes. This underscores the need for a more comprehensive approach to scoliosis treatment.

2\. Description and classification of medical device i-Factor Peptide Enhanced Bone graftTM: "i-FACTOR Bone Graft is a pure, natural form of hydroxyapatite (anorganic bone mineral or ABM) containing P-15™, a synthetic peptide. It is provided in putty form, comprised of ABM/P-15 particles that are suspended in an inert biocompatible hydrogel. Hydroxyapatite is the major mineral component of bone. P-15 is a fifteen amino acid sequence polypeptide, a portion of Type-I collagen that serves as a biomimetic attachment site for bone cells. The hydrogel carrier (glycerin and carboxymethylcellulose, or CMC) forms the matrix that improves overall the handling characteristics and helps contain the i-FACTOR Bone Graft at the surgical site. The bovine-derived ABM particles within the matrix are radiopaque and sized between 250 and 425 microns. i-FACTOR Bone Graft provides a bone graft substitute that is remodeled into new bone during the natural healing process." The i-Factor Peptide Enhanced Bone graftTM is classified as a CE-marked class III medical device. i-Factor flex FRTM: "i-FACTOR Bone Graft is a pure, natural form of hydroxyapatite (anorganic bone mineral or ABM) containing P-15, a synthetic peptide. i-FACTOR Flex FR is comprised of ABM/P-15 particles that are suspended in an inert biocompatible carrier, and has been lyophylized (freeze-dried) to form flexible strips. Hydroxyapatite is the major mineral component of bone. P-15 is a fifteen amino acid sequence polypeptide, a portion of Type-I collagen that serves as a biomimetic attachment site for bone cells. The carrier (carboxymethylcellulose, glycerin, and purified silk) forms the matrix that helps contain i-FACTOR Flex FR at the surgical site. The bovine-derived ABM particles within the matrix are radiopaque and sized between 250 and 425 microns. i-FACTOR Flex FR provides a bone graft substitute that is remodeled into new bone during the natural healing process." The i-Factor flex FRTM is classified as a CE-marked class III medical device. Rationale for the project ASD is associated with excessive pain, severe disability and significantly reduces health-related quality of life. Surgical treatment is often considered the only viable option in patients with severe ASD, although surgery is associated with certain risks. In ASD surgery, the risk of revision surgery due to either postoperative mechanical failure of the implants or pseudarthrosis is common. Although several changes to treatment have been implemented in the last decade, revision surgery is still common and necessary in up to 30% of patients following the index procedure. Therefore, increased attention has been directed towards reducing the risk of pseudarthrosis, and ABM/P-15 bone graft may play a considerable role in preventing that. The effects have previously been described in patients undergoing cervical spinal discectomy with promising results. Promising results has also been found in the treatment of periodontal infrabony defects through enhanced regenerative bone capacity. Furthermore, ABM/P-15 bone graft in combination with locally harvested autograft has shown superiority compared to allogenic bone graft in non-instrumented posterolateral fusion. The use of ABM/P-15 bone graft has, however, not been assessed in patients undergoing long instrumented spinal fusion surgery which is the case in ASD surgery. The ABM/P-15 bone graft will be used as its CE-mark intends. Literature Since the introduction of iliac crest bone graft (ICBG) in 1958 leading to enhanced spinal fusion rates and lowering the rate of pseudarthrosis, bone grafts have been widely accepted as a supplement to instrumented fusion. Autologous bone graft taken from the iliac crest is often considered "gold standard" in spinal surgery due to its biomechanical properties of osteoconductivity, osteoinductivity, and osteogenesis. Osteoconduction is the combination of the three-dimensional structure of the bone graft and the capability of new bone formation on this particular scaffold. Moreover, availability of growth factors stimulating undifferentiated pluripotent cells into bone-forming cells is known as osteoinduction. Lastly, osteogenetic properties in bone synthesis rely on the continuous contribution of vital and established osteoprogenitor cells. Autologous bone graft consist of all three biomechanical properties however; the supply of is limited. Additionally, the use of autologous bone graft has been associated to potential donor-site complications, forcing surgeons to look for other viable options such as allogenic bone grafts or other alternatives such as demineralized bone matrix ceramics, bone morphogenetic protein, autologous growth factors, stem cell products (allogenic bone graft cellular matrix), synthetic peptides and bioactive peptides. Allogenic bone graft is described as the transfer between two genetically dissimilar individuals of the same species and is the second most transplanted tissue only surpassed by blood transfusions. Allogenic bone graft bears the properties of full osteoconduction, variably osteoinduction but completely lacks osteogenic properties due to loss of cellular elements. However, industrialized allogenic bone grafts, as well as other non-autologous bone grafts, does have some important advantages compared to autologous bone graft including decreased operative time, decreased blood loss, no donor-site morbidity and finally, almost unlimited quantities. The allogenic bone grafts (morselized femoral heads) from local bone banks are naturally with some restrictions to quantities, however; allogenic bone grafts compared to autologous bone grafts are more accessible. The use of bioactive peptides bone grafts (ABM/P-15), such as "i-FACTOR Peptide Enhanced Bone Graft" (Cerapedics, Inc., Westminister, CO), has shown similar effects in PROMs and even superiority in terms of faster formation of bridging bone within 12 months, compared to the "gold standard" autologous bone grafts. ABM/P-15 bone graft is a composite bone substitute consisting of an anorganic bovine-derived hydroxyapatite matrix (ABM) combined with a synthetic 15 amino acid peptide (P-15). The ABM/P-15 bone graft matrix bears the properties of osteconductivity, osteoinductivity and subsequent osteogenesis. The osteconductive ABM acts as a scaffold for the osteoinductive peptide P-15, acting as a binding site for the α2-β1 integrin (Type I collagen) initiating intra- and extracellular signaling pathways for increased production of growth factors, bone morphogenic proteins (BMP) and cytokines. The increased cell proliferation and differentiation ultimately results in osteogenesis. In a randomized double-blinded clinical trial, significantly increased fusion rates with the use of ABM/P-15 bone graft combined with locally harvested autograft compared to allogenic bone grafts in non-instrumented spondylolisthesis were reported. However; this did not result in overall improved PROMs in the reported 2-year follow-up period. In a systematic review, the total number of ASD surgeries in Medicare USA increased fourfold between 2000 and 2010 and additionally increasing the total costs of spinal deformity surgeries by a 16-fold from $56 million to $958 million 40. One possible explanation could be the increasing elderly population, possibly leading to increased complications and revision surgeries, imposing a major financial and clinical burden on the health care system. Several other studies also suggests the substantial increase in the frequency and expense of ASD surgery. Given the same effectiveness between two surgical index procedures, the natural choice would be to pick the less expensive procedure. However, transparency of costs (direct cost, indirect cost) may economically benefit the health care system through overall reduced patient cost. In a economic evaluation of perioperative adverse events (AE) associated with spinal surgery, an AE rate of 17.4% accounted for 16% of the total in-hospital cost. Optimally, ABM/P-15 bone grafts could reduce complications, revision surgeries and overall costs per patient. The use of autograft, allogenic bone grafts, Bone Morphogenic Protein (BMP) etc. have been extensively described in ASD patients, however; the use of the ABM/P-15 bone graft has not yet been assessed in this patient population, despite promising effects in other surgical fields. To our knowledge, only five clinical articles have been published regarding the use of ABM/P-15 bone graft in patients with spinal conditions. Of these five clinical studies, one is an annual 2-year follow-up on a previous RCT study, whereas a second study is the use of ABM/P-15 bone graft compared to allogenic bone grafts in non-instrumented lumbar fusion surgery, leaving three studies undertaken in patients undergoing instrumented spinal fusion surgery. One study (level I evidence) reported in the ABM/P-15 bone graft FDA IDE trial study similar fusion rates compared to autograft in single-level anterior cervical discectomy and fusion (ACDF). Another study (level III evidence) reported similar fusion rates compared to autograft in posterior lumbar interbody fusion (PLIF). Lastly, the third study (level IV evidence) reported satisfactory fusion rates for patients who underwent anterior lumbar interbody fusion (ALIF). Conclusively, our study will be the first to examine the use of ABM/P-15 bone graft both in patients undergoing more than one level of instrumented fusion and in ASD patients. The current findings supplemented with the results of this study will be of significant value, since spinal surgery often involves multiple levels of fusion. Furthermore, our study will merely be the second level I next to the FDA IDE trial study performed in 2016. The use of ABM/P-15 bone graft has, furthermore, been used in the field of odontology regarding periodontal regeneration. Several studies showed significantly enhanced regenerative bone capacity and provided overall better clinical results in the treatment of periodontal infrabony defects. 4\. Main Purposes In a prospective trial, patients undergoing surgery for Adult Spinal Deformity (ASD) will be randomized into two groups. One group receiving the standard bone graft which is a mix of locally autologous harvested bone and a morselized femoral head (allogenic) and the other group will receive bone graft of anorganic bovine bone mineral coated with a bioactive peptide (ABM/P-15). The following parameters across groups will be assessed: 1. The incidence of revision surgery 2. Patient reported outcome measures (PROMs) preoperatively, at 3 months, at 1-year and 2-year follow-up 3. Evaluation of fusion based on CT-scans at 1-year follow-up e. Perioperative adverse events f. Cost-effectiveness Main hypotheses 1. The use of ABM/P-15 bone graft is superior to traditional treatment with a mix of locally autologous harvested bone and a morselized femoral head (allogenic) regarding incidence of revision surgery following index surgery for ASD Secondary hypotheses 2. The investigators expect non-inferiority in PROMs in the ABM/P-15 bone graft group compared to the control group 3. The investigators expect non-inferiority in the postoperative fusion rates evaluated on CT scans in the ABM/P-15 bone graft group compared to the control group 4. The investigators expect non-inferiority in postoperative incidence of asymptomatic pseudarthrosis in the ABM/P-15 bone graft group compared to the control group 5. The investigators expect non-inferiority in perioperative adverse events in ABM/P-15 bone graft group compared to the control group 6. The investigators expect the use of ABM/P-15 bone graft to be cost-efficient compared to the traditional treatment in the control group 5\. Materials and methods Study design Prospective, single-blinded, randomized, controlled clinical trial at a quaternary specialized spine unit covering all deformity surgery in eastern Denmark. Methods of analysis A prospective, single-blinded, randomized, controlled clinical, single center study where patients scheduled for elective ASD surgery are randomized to receive either bone grafts of ABM/P-15 or the standard locally harvested autograft combined with allogenic bone graft. Group A: bone graft of anorganic bovine bone mineral coated with a bioactive peptide (ABM/P-15) mixed with locally harvested bone graft. Will be placed directly on the lamina and or in between transverse processes if no lamina. It will be contained by the muscle layer. Group B: standard bone-grafting which is a mix of locally harvested bone and a morselized femoral head (allogenic) Patient data will be recorded in RedCap, which will generate a random generic identifier number (ID). All patients will receive the following examinations at the described time: Questionnaires (30 min): 14 days prior to surgery, 3 months postop, 1 year postop and 2 years postop X-rays (30 min): 14 days prior to surgery, 7 days postop, 3 months postop, 1 year postop and 2 years postop CT-scan (30 min): 1 year postop Incidence of revision surgery will be defined as revision surgery due to any of the following: * Implant failure (e.g rod breakage, screw breakage, cage displacement/subsidence) * Pseudarthrosis assessed by CT-scan Posterolateral fusion will be defined according to the Lenke fusion grading system (Type A-D). Type A and type B will be defined as having fusion, whereas type C and type D will be defined as non-fusion. Radiographic signs of pseudarthrosis (in accordance to the above) in combinations with patient reported complaints, including pain, will be defined as symptomatic pseudarthrosis, and asymptomatic pseudarthrosis in cases of radiographic pseudarthrosis without patient reported complaints. The need for accessory anterior support will be assessed for each individual patient, and utilized through ALIF/PLIF. These patients will receive ABM/P-15 bone graft inside the cage. Radiographic non-fusion of ALIF/PLIF will be defined as one of the following: * Lack of substantial sclerotic changes in the recipient bone bed * Lack of visible bridging bone either through the cage or surrounding it as observed on anterior-posterior or lateral radiographs * Vertebral body translation of \<3 mm on lateral radiographs Bone graft migration at 3-months follow-up will be evaluated on radiographs. Comparison will be made to the immediate postoperative radiographs. Statistical analysis: All statistical analyses will be performed by the primary investigator using R (R Development Core Team, 2011, Vienna). P \< 0.05 will be considered significant. Patient characteristics 1. Continuous data will be compared using Student's t-test (Gaussian distributed data) or Wilcoxon's sum rank test (non-Gaussian data) 2. Categorical variables will be compared using Chi squared or Fisher's exact test Randomization procedure Group A: bone graft of anorganic bovine bone mineral coated with a bioactive peptide (ABM/P-15) Group B: standard bone graft which is a mix of locally harvested bone and a morselized femoral head (allogenic) The cohort will be block randomized (10 in each block) according to the above mentioned two groups. Patients will be informed about the possibility of receiving ABM/P-15 bone graft or standard locally harvested autograft combined with allogenic bone graft. The primary investigator will be responsible for the randomization without bias through block randomization of ten patients in each block. The primary investigator will make ten identical envelopes, five with the text "Group A" and five with the text "Group B". The envelopes will be shuffled, and the surgeon will hereafter be presented the ten envelopes and randomly select one. At the next ASD surgery for a new patient, the surgeon will be presented the remaining nine envelopes. When all ten envelopes have been picked for surgery, ten new ones will be made. This randomizes the selection of bone graft bias-free with a fifty-fifty percent chance of ending in either group A or group B. The practical completion and investigation of the study Patients evaluated at a multidisciplinary conference and afterwards scheduled for ASD surgery will be identified in the electronic medical records system (Sundhedsplatformen). Patients eligible for inclusion will at first outpatient visit to plan further final surgery (approx. 2 weeks prior to surgery), be informed about the study both in written form and orally. This information will be given by the primary investigator and/or the spine surgeon in a closed separate room after initial surgery planning. All patients have the right to an assessor to all outpatient visits and also during the written and oral information regarding the clinical study. If the patient wishes to bring an assessor to the information meeting regarding the clinical study, a new appointment can be made 3-10 days prior to the surgery date. Therefore, participating in this study will in no way impact the date of the surgery and further treatment. On the day of surgery, a written informed consent will be obtained should the patient decide to participate in this study. No patient will have less than 48 hours to answer, complied with the Helsinki declaration. After the patient agrees to participate in the study the primary investigator will randomize the patient to receive either ABM/P-15 bone graft or the standard of locally harvested autograft combined with allogenic bone graft according to the above mention section "randomization procedure". Deviations from standard treatment There will be no deviations from standard treatment since patients will receive either ABM/P-15 bone graft or the similar standard of locally harvested autograft combined with allogenic bone graft. All patients will be treated with a posterior spinal instrumentation and fusion (PSF) procedure and anterior support whenever deemed necessary at the surgeon's discretion. Choice of implants, osteotomies, numbers of levels fused will be decided prior to randomization at the multidisciplinary conference where final indication for surgery is confirmed. Cost-effectiveness analysis The overall cost per patient undergoing ASD surgery (incl. pre-, peri- and postoperative costs) can be estimated, using: diagnosis codes, procedural codes incl. supplemental codes in conjunction with data extraction from electronic medical records (Sundhedsplatformen). The total cost is calculated using diagnosis-related group (DRG) rates (this include for example: cystitis, pneumonia etc.). In the preoperative phase, the investigators will mainly analyze the ABM/P-15 bone graft (i-FACTOR Peptide Enhanced Bone Graft, Cerapedics) purchase price per patient compared to the cost of allogenic morselized femoral head. Furthermore, the investigators will note if extra clinical controls are required. In the perioperative phase the investigators will look at surgery time (incision time), time in theater, personnel involved, use of surgery equipment, planning time, waste time etc. The postoperative phase will be divided into cost during admission and cost after discharge from the hospital. Here, the investigators will analyze, in particular, the rate of revision surgery and other adverse events during admission. Additionally, length of hospital stay, complications to surgery, readmission to hospital following discharge, including readmission reason, department, time and length of readmission will be analyzed. Moreover, the investigators will look at the total cost of rehabilitative care and use of pain medication following discharge. All reimbursed prescription medicine is recorded in The Danish National Health Service Prescription Database (DNHSPD). These data will be gathered and analyzed as part of the total cost of rehabilitative care. Finally, information regarding reimbursed physiotherapy will also be gathered and analyzed. 6\. Statistical considerations Using: \- Alpha = 5% \- Statistical power = 80% \- Estimated revision rate in the non-intervention group: 30% \- Estimated revision rate in the intervention group: 15% Sample size calculation resulted in a sample size of n = 102 in each group. In the study the investigators have planned to include and randomize (block-randomization with 10 in each block) a total of 240 patients. This will secure a high statistical power even if some of the participants should drop out during the study. 7\. Patients The participants of the study will be 240 patients that have been scheduled for elective ASD surgery using the usual indications for ASD at the Spine Unit, Department of Orthopedic Surgery, Rigshospitalet. ASD with indication for surgery will be defined as any spinal procedure requiring posterior instrumented fusion at a minimum of 5 levels to the sacrum. Patients who have undergone previous lumbar spine surgery for a degenerative condition will be eligible for inclusion. 8\. Risks, side effects and disadvantages The main risks of ASD surgery involve infection, blood-loss, embolism, paresthesia, paralyses or even death. Based on previous studies with ABM/P-15 bone graft, participation in the present study will not expose the patients to any added risks of these complications. Side effects and disadvantages that may occur in this clinical trial study (approved in accordance to the regulation rules of medical devices), will be reported to the "Danish Medicines Agency". Radiographs: Patients will follow the department's routine regarding long standing radiographs pre- and postoperatively after 1 week, 3, 12 and 24 months. The standard procedure at our institution is that patients undergoing surgical treatment for ASD are scheduled for a CT-scan 1-year postoperatively. In the present study, the investigators will use this opportunity and analyze the already planned CT-scans in our study. In the written consent form patients are asked (yes:no) in regards of recieving information about the clinical study results as well as any consequences the study might have for the individual patient. In case of any secondary findings on the radiographs, patients who replied "no" on the form will not be informed about these findings. Patients who replied "yes" on the form will be informed about any secondary findings on radiographs and proper treatment will hereafter be initiated. The treatment includes referral to the proper department responsible for treating the specific secondary finding. 10\. Information via electronic medical records (Sundhedsplatformen) Variables collected: ● Name ● CPR-number ● Address and phone number * Birthdate * Sex * Diagnosis * Lifestyle factors such as alcohol consumption, caffeine intake, smoking habits, weight, height and exercise * Comorbidities and a ASA score, including medical treatments (including, but not limited to, hypertension, hypercholesterolemia, diabetes mellitus/HbA1C, dialysis dependence, chronic venous insufficiency, end-stage renal disease, liver disorder, congestive heart failure, osteoporosis, ostemalacia, Paget's disease, disseminated cancer diseases, severe psychiatric diseases) All above mentioned information gathered via electronic medical records will be used before patient consent and are essential to the clinical study in terms of the recruitment of patients. This information will hereafter be passed on to the primary investigator. All below mentioned information gathered via electronic medical records will be used after patient consent. This information is essential to the clinical study in order to proper analyze differences among patients and thereby, conclude on these findings the differences between the ABM/P-15 bone graft versus the traditional bone graft in Adult Spinal Deformity surgery. This information is in particular of relevance in spine surgery when evaluating differences in bone graft treatment. Furthermore, in order to analyze correlations between the two groups, the investigators believe that the below mentioned information are essential in order to make the correlations analysis. ● Previous surgical procedures of the spine (date, type and implants) ● Surgical parameters, including blood-loss, surgery time, fluid-replacement therapy, levels of surgery, implant types. ● Complications to surgery * Adverse events during admission * Readmission to hospital following discharge, including readmission reason, department, time and length of readmission * Mortality * Previously filed patient-reported outcome measures * Length of hospital stay From phone conversations or outpatient clinic visits the following information are collected: * Occupation * Current use of pain medication * Rehabilitative care (expenditures) All radiographs will be analyzed which is the standard procedure for all patients undergoing ASD surgery at our institute. After written consent from the patient, the primary investigator and Spine unit, Department of Orthopedic Surgery 6011C, Rigshospitalet, will get direct access to the patient's electronic medical records in order to collect the above mentioned variables as a part of this clinical trial study. 11\. Sensitive patient data All sensitive patient data gathered in this project are protected under "General Data Protection Regulation" and "The Data Protection Act". All data will be anonymized. No personally identifiable information will be shared with Cerapedics. Only a gathered anonymized data pool with all patients included could potentially be shared and will in no circumstances include sharing of patient data on individual level. In short, no patient will be identifiable. 14\. Recruitment of patients and informed consent The primary investigator/or surgeon will preoperatively inform potential ASD patients about this scientific study regarding the use of ABM/P-15 bone graft versus locally harvested autograft combined with allogenic bone graft at first outpatient visit to plan further final surgery (approx. 2 weeks prior to surgery). All information regarding the scientific study will be given in a closed separate undisturbed room. The patient has the right to an assessor at the conversation. If the patient wishes to bring an assessor to the information meeting regarding the clinical study, a new appointment can be made 3-10 days prior to the surgery date. Therefore, participating in this study will in no way impact the date of the surgery and further treatment. Patients will be thoroughly informed about this clinical trial, handed the "Participation information", "Before participating" and "Participants rights in a scientific researh project" sheets and all questions regarding the study will be answered to the best of spine surgeons abilities. Furthermore, patients will be informed that no participants will have to have to make a final decision at this time and that cancelation of participation in the study will not influence treatment pre-, peri- or postoperatively. No participants will have less than 48 hours to answer, complied with the Helsinki declaration. However, if the patient agrees to participate in this study by signing a written consent, the primary investigator will inform the surgeon on whether to use ABM/P-15 bone graft or the standard locally harvested autograft and allogenic bone graft on the day of surgery as described. It is the primary investigators responsibility and duty to make sure the above mentioned criteria are met. Copies of information and informed consent will be given to subjects in this trial. 15\. Publication of results All results, including positive, negative or inconclusive results will be published in peer-reviewed scientific journals. Publications will be done as follows: 1year follow-up study of the interim results 2year follow-up study of the final results 16\. Ethical considerations The investigators do not expect that patients participating in the study will experience any special side effects or complications directly related to the specific use of ABM/P-15 bone graft. Patients in both groups will receive the needed amount of bone graft evaluated by the surgeon. The purpose of giving ABM/P-15 bone graft is to provide better clinical results through faster fusion and higher fusion rates, fewer complications, no additional surgeries and improved overall PROMs postoperatively. There has not been performed any fundamental changes in the overall surgery with this new bone graft type. Additionally, a cost-effectiveness analysis of ABM/P-15 bone graft will be performed and might optimize resources in the health care system. This analysis will have no impact on the treatment of patients in this study. The study will not be started until approval from the Scientific Ethical Committee of the Capital Region of Denmark and the Danish Data Protection Agency has been obtained, and it will be registered at clinicaltrials.gov. All patients will receive both oral and written information before informed consent to participate is obtained. The significant usefulness of the present study is to gather new knowledge concerning further optimization of clinical result postoperatively from ASD surgeries. Knowledge from our study will benefit society in general and optimize utilization of resources, in terms of best treatment for future patients. In case of serious adverse preliminary results, data will be analyzed and if this treatment is found to cause significant critical problems compared to other bone grafts (p\<0.05), the study will be ended. This preliminary analysis will be performed after the inclusion of 5% of the patients in order to validate the effect of treatment and adverse events. The study is thus designed to minimize unnecessary risk to the patients. 17\. Information regarding compensation The participants are covered by the Danish Patient Compensation Association.

This study aims to develop a new instrument capable of providing an efficient measure of the quality and quantity of adherence to Physiotherapy Scoliosis Specific Exercises performed at home by growing patients with spinal deformity undergoing conservative treatment at a specialized institution. The development of a questionnaire in a Rasch environment and specifically developed for this population will ensure greater sensitivity and specificity of the questionnaire.

Creation of a pediatric robotic spine surgery registry will allow for data collection and analysis on the coupled use of robotics and navigation, as well as patient-specific rods in pediatric spine deformity surgery across participating study institutions. Eventually, an educational and informative framework for this technology will be established.

Background Spinal deformity is a prevalent spinal disorder in both paediatric and adult populations. The spine alignment need to be quantitively assessed for further treatment planning. However, the current practice requires spine surgeons to manually place landmarks of endplates and key vertebrae. The process is laborious and prone to inter- and intra-rater variance. Thus, the investigators have developed an AI-powered spine alignment assessment system (AlignProCARE) to facilitate clinicians in fast, accurate and consistent analytical results. The investigators aim to test and improve the performance of the spine alignment auto-analysis in all patients with spinal deformities in multiple centers including Malaysia, China, and Japan Objectives: 1. prospectively test the alignment assessment of patients' spinal deformities with whole spine X-rays (both PA and lateral) and nude back image with the assessment via AlignProCARE. 2. Collect 500 labeled deformity radiographs and nude back images in both PA and lateral views per center. 150 patients need to be followed up with radiographs and nude back photos collected (all parameters measured again). 3. Use transfer learning to update the current AlignProCARE for scoliosis analysis to form AlignProCARE+. 4 Qualitatively analyse the AlignProCARE+ using an independent dataset.

The overall aim of the project is to initiate the shift from 2D to 3D mechanically correct and dynamically informed decision-making in Adolescent Idiopathic Scoliosis (AIS), by identifying and integrating the key parameters that overcome the present limitations of 2D static AIS care. Within the timeframe of the project, we will not be able to identify and integrate the key parameters that will overcome all undesired surgical outcomes and therefore, in addition to the overall surgical outcome assessed by patient reported outcome measures (PROMs) we will specifically focus on post-surgery shoulder balance. Since an elevated shoulder after surgery is one of the most common undesired surgical outcomes (approximately 16% of the treated AIS patients) linked with treatment satisfaction and psychological well-being. To achieve the overall aim, the project comprises two objectives that will allow us to advance towards 3D dynamically informed decision-making in AIS care: 1. To shift towards a 3D mechanically correct overview of the spinal deformity. The current state-of-the-art guidelines for the selection of fusion levels in AIS patients are based on 2D static radiographic parameters\[26\]. In order to improve the current state-of-the-art evaluation method, efforts should be made towards a 3D dynamic visualization of the deformity, especially considering that AIS is a 3D deformity of the spine. In addition, the treating surgeon has only limited information on the mechanical behavior of the spine of the AIS patient as the traction radiograph tests that show the displacement of the spine are typically only assessed qualitatively. To overcome this issue, the spine stiffness should be incorporated in order to thrive towards a biomechanically-informed state-of-the-art 3D model. 2. To identify the key 3D parameters that should be considered by the surgeon Once a biomechanically-informed subject specific 3D model that incorporates the mechanical behavior of the spine is developed within objective 1, the crucial next step will be to identify the key parameters that have the potential to improve the clinical decision-making in AIS. As highlighted before, we will focus on post-surgery shoulder balance and the PROMs.

3D technology is increasingly being used, especially in orthopaedic surgery and traumatology as it allows to define specific objects and to understand structures and system dynamics. From patient TC images and using a biomedical engineering software, an exact 3D virtual model of the anatomical region can be created, enabling visualization, planning and simulation of the entire surgery. Besides, this software allows to design custom-made surgical guides (that precisely define cutting zones and screw positioning) as well as personalized implants that perfectly fit the patient's anatomy. After that, Patient-Specific Instrumentation can be manufactured using 3D printers and biocompatible materials and they can be sterilized to be used in the operating room. While personalized surgical guides increase surgical precision and surgeon satisfaction, personalized implants have shown to generate better clinical outcomes, both short and long term. Despite of the benefits that 3D technology can generate in the medical field, most surgeons still opt for conventional 2D planning techniques, free-hand surgeries and generic implants use. This results in a non-standardized and variable procedure that heavily depends on the surgeon´s experience and in many cases, the obtained results deviate from the initial goals. Scientific evidence shows that a lack of precision is strictly related to clinical complications. Poor alignment of the implants can cause damage to internal structures, increases chances of dislocations, fractures and osteolysis as well as reduces the prosthetic component lifespan. That translates into patient suffering from chronic pain, reduced functionality and an increased number of reinterventions. Regardless of the potential and several applications of 3D technology, there´s still a lack of clinical evidence, and the economic impact is still unknown. This methodology is increasingly being used as a routine medical process in many institutions but still raises concerns regarding costs, specially when considering its use in the public health system. Although digital surgery has a wide variety of associated expenses such as hardware and software cost, equipment maintenance and 3D-specialised engineers, the cost of 3D technology has significantly decreased in the past few years and it can potentially generate economic benefits compared to the standard methodology due to the optimization of the surgical process; shorter surgeries, reduced number of unnecessary sterilized materials, reduced number of fluoroscopies during surgery and less medical complications and revisions. Thus, a large-scale study is still needed to demonstrate: 1) clinical benefits that 3D technology can generate compared to conventional surgery and 2) thoroughly analyse its economic impact to determine if it's a cost-effective methodology. For this reason, a multi-centre, randomized and prospective study is proposed to evaluate digital surgery's clinical results and to perform a cost-effectiveness analysis in order to obtain enough scientific evidence to be able to escalate the use of 3D technology in all public health institutions. This clinical trial is a pragmatic study that will evaluate the efficacy and effectiveness of 3D technology in 3 different surgical procedures; distal radius osteotomy, acetabular arthroplasty and spinal arthrodesis.

In 2023, conducted the study in Basic Science Department,. Forty participants (females) with UCS were randomly divided into two equal groups: group A (control group) and group B (experimental group). Both groups received two sessions per week for four consecutive weeks. Group A received traditional physical therapy program in form of stretching, strengthening and postural correction exercises while Group B received Pilates exercise program. Primary outcome measures were balance, spinal curvature, Craniovertebral angle (CV), and rounded shoulders. Result was Comparison between pre-and post-treatment .Conclusions was Pilates exercise program proved better than traditional physical therapy program in improving spinal curvature, balance, and function and reducing pain in UCS.Randomized clinical trials (RCTs) were conducted to identify the effectiveness of whole-body vibration (WBV) on strength, power, and muscular endurance in older adults. However, the results of different studies are contradictory.. Conclusion: WBV was effective in increasing lower limb muscle strength. However, no significant results were observed for upper limb strength, lower limb power, and lower and upper limb muscle endurance in older adults. However, more studies are needed to better understand the physiological impacts of WBV in older.A randomized controlled trial was conducted in 2017.The present study aimed to determine the immediate effects of Whole Body vibration (WBV) on Rounded Shoulder Posture (RSP) in healthy women. Thirty female students aged between 18 to 30 years with RSP participated in this study. First, the examiner measured the RSP (in supine position), Pectoralis Minor Length (PML) and Total Scapular Distance (TSD). Then, the subjects performed 5 sets of 1-min WBV (frequency=30 Hz, amplitude=5 mm) with 1 min rest between each set. After intervention, the examiner immediately measured the above mentioned variables. The paired t test was used for data analysis. The analysis showed that WBV significantly decreased the supine measurement of RSP (P\<0.001) and TSD (P=0.03) and increased PML (P \<0.001). It seems that WBV had immediate effect on postural correction of rounded shoulder posture in the study subjects.While posture is a prevalent issue among young adults due to prolonged sitting and increase use oftechnology, the majorityofresearch studies have primarily focused on other age groups, such as older adults or adolescents and most of work on lower limb , very little study was done in upper limb regarding this issue among young adults.As my study focus posture correction in upper croos syndrom patient . After study some literature found to the best of authors knowledge, although in the past many studies have worked on correction ofposture leading to forward head posture and rounded shoulder in upper cross syndrome.There are different exercise regimes for RSP such as strengthening of lengthened muscles, scapular stabilizers, stretching of shorten muscles especially pectoral muscles, and soft tissue mobilization Pilate exercises and whole body vibration have been practiced in the treatment of forward head posture and RSP were found effective individually,butthereisalackofComparison of pilot exercises with and without whole body vibration on posture , disability and pain in patients with upper cross syndrome . This RCT aims to evaluate the effect of WBV with exercise and effect of Pilate exercises without WBV will ascertain thatiftwoofthese mayhave differenteffectsonthepain, posture, disability in young adults with upper cross syndrome.

The study focuses on understanding Kyphosis, defined as excessive forward curvature of the thoracic spine, has become increasingly prevalent in modern work environments due to the sedentary nature of desk jobs. Kyphosis, characterized by a rounded upper back or "hunchback" appearance, is a clinical and postural problem with significant physical, functional, and psychosocial implications. Among office workers, the condition is primarily postural, driven by long hours of desk work, inappropriate ergonomic settings, and inadequate postural awareness. The increasing prevalence of kyphosis in this demographic has led to a pressing need for effective nonsurgical management strategies, including physical therapy (PT) and spinal bracing.

Specific Aims: • Evaluate surgical treatment outcomes and identify best practice guidelines for complex adult spinal deformity (ASD) patients, including radiographic and clinical outcomes, surgical and postoperative complications, risk factors for and revision surgery rates, and the role of standard work to improve patient outcomes and reduce surgical and postoperative complications. a. Complex ASD patients will be defined based upon clinical, radiographic and/or procedural criteria identified in an analysis of the existing ISSG ASD database: i. Magnitude of coronal and/or sagittal spinal deformity ≥75th percentile of patients in the ISSG database. ii. Clinical or Radiographic parameters that corresponded to patients in the ISSG database that had complications requiring revision spine surgery and/or patients that had hospital length of stay \>9 days. iii. Procedures involving 3 column osteotomies and/or anterior column reconstruction (ACR) of the spine * Develop and validate a standardized, universal complications classification system for spine surgery * Evaluate perioperative blood management approaches, transfusion requirements, including variance in thresholds for blood transfusion and associated complications for adult spinal deformity surgery * Assess impact of opioid use and pain management on patient cost, complications and outcomes * Evaluate optimal opioid and analgesic usage and protocols for standard work development * Evaluate clinical outcomes utilizing legacy patient reported outcome measures (PROMs) including modified Oswestry Disability Index (mODI), Scoliosis Research Society Questionnaire 22r (SRS-22r), Veterans RAND-12 (VR-12), and numeric pain rating scale (NRS) and compare the results of these legacy PROMs to outcomes scores as measured by the NIH Patient Reported Outcomes Measurement Information System (PROMIS) - PROMIS Anxiety, Depression, Pain Interference, Physical Function, and Social Satisfaction. Secondary aims for PROM research for this study include 1. Validation of the PROMIS tool for ASD 2. Establish a core set of PROMs for best practice guidelines for ASD 3. Evaluate patient reported outcome variance for ASD according to SRS-Schwab spine deformity type including variance in baseline PROM domains impacted and variance in improvement in PROM domains 4. Evaluate ASD outcomes compared to population norms and investigate/develop appropriate measures of clinically significant improvement * Evaluate clinical outcomes stratifying by patient chronological and physiological age * Evaluate measures to quantify patient physiological age including patient frailty for ASD and validate a frailty measurement system for ASD * Evaluate the role of functional tests in patient's baseline frailty assessment including hand manometer and Edmonton Frail Scale. See appendix, pages 17 \& 18 for details. * Evaluate the contribution of patient frailty to patient outcomes, cost of care, disability, and complications * Evaluate if patient frailty is a static measure or if frailty is a dynamic measure that can be improved through "pre-habilitation" and if the according associations with reductions in frailty correlate with reductions of cost, complications, and improvement in outcomes * Evaluate cost variance for ASD surgery according to patient, institution, and geographical region and evaluate the cost effectiveness of surgical intervention for ASD * Evaluate incidence of and risk factors for mental health (MH) compromise among ASD patients and establish best practice guidelines for assessing MH for ASD patients * Evaluate the association of MH with surgical complications, outcomes, hospital length of stay and cost for ASD surgery * Evaluate the association of social health surgical complications, outcomes, hospital length of stay and cost for ASD surgery and risk factors for routine (home) discharge vs. skilled nursing facility (SNF)/rehabilitation facility * Broaden the evaluation of the surgically treated ASD patient to maximize evaluation of the entirety of the episode of care to include steps that can be taken prior to surgery including "prehabilitation," pain management, and MH care to improve treatment outcomes, reduce cost, reduce hospital length of stay, reduce non-routing discharge and reduce early and late complications * Establish a core set of standard work guidelines to clinically and radiographically evaluate and treat ASD patients and evaluate the utility of standard work to improve outcomes for ASD and formulate best practice guidelines for surgical treatment of ASD * Develop predictive analytic algorithms to risk stratify for best/worst outcomes, complications, sentinel events, and economic loss for ASD surgery