Spinal Stenosis

The goal of this quasi-experimental study is to examine the effects of a venous thromboembolism prevention program, or "5E" program, on the rates of venous thromboembolism in patients with spinal cord disorders. The main questions it aims to answer are: * Will participants receiving the 5E program have lower rates of venous thromboembolism compared to those receiving the usual care? * Will participants receiving the 5E program have lower scores of venous thromboembolism signs and symptoms compared to those receiving the usual care? * Will the average thigh and calf circumferences of participants before and after receiving the 5E program be different? Participants in the intervention group will receive the 5E program, including * Education: health education regarding venous thromboembolism prevention * Elevation: leg elevation of 10-20 degrees * Exercise: ankle exercises * Enough fluid: adequate fluid uptake * Early application of intermittent pneumatic compression (IPC): IPC use within 48 hours after admission

The therapy being trialed in this study uses motor learning theory to try and improve or change walking patterns to improve the child/teen's walking goal. Therapy will target their own walking goal and they can choose the format of their therapy as long as they complete 30 hours of which 24 hours must be in the clinic within a 6 week period.

Degenerative Cervical Myelopathy (DCM) is a prevalent degenerative spinal disease that often goes unnoticed by general clinicians due to its non-specific and subtle signs and symptoms in its early stages. Delayed identification of DCM may lead to poor surgical outcomes or permanent disability, impacting the quality of life of affected individuals. Incoordination in hand and gait movements are early signs of DCM that worsen with disease progression. Despite validated performance tests for DCM, there is currently no objective criterion for functional deficits in aiding clinical decision-making for surgery or diagnosis. To meet the pressing global need for objective functional criteria, this study aims to develop surgical criteria specific to DCM. This will involve using physical performance tests, in addition to evaluating MRI findings of cord compression, clinical signs, and the modified Japanese Orthopedic Association (mJOA). By expediting the surgical decision-making process, we hope to improve recovery outcomes for individuals with DCM worldwide

The surgical operation will be carried out according to the standard clinical practice, namely following the modified Lapidus general and specific rules concerning the surgical treatment of hallux valgus with/without an Akin or a Weil/Hohmann surgery fusion. Post-operatively, patients who meet the eligibility criteria will be randomized into one of the two groups (partial weight-bearing limited at 15kg vs full weight-bearing) Patient in both groups will be wearing a VACOPASO shoe for 6 weeks. Standard X-ray assessment to determine healing, hardware fixation, fracture alignment, fracture reduction, implants mobilization will be performed at weeks 6, 12, 24. Change in pain severity from the day of surgery to 6, 12 and 24 weeks postoperatively will be measured using the pain Visual Analogue Scale (VAS). Quality of life will be assessed through the American Orthopedic Foot and Ankle Score (AOFAS). Subjective functional recovery through the Olerud and Molander Ankle Score (OMAS).

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 is an interventional, non-pharmacological, randomized controlled superiority study (RCT), multicenter, open label, parallel group. The aim is to evaluate the effectiveness of a new preoperative information method, based on multimedia tools and on the objective control of understanding by the patient candidate for spinal or urological surgery.

Disease background: While lumbar spinal stenosis (LSS) is one of the most common degenerative diseases of the spinal column, there is no universally accepted definition of LSS, and no accepted radiologic diagnostic criteria. LSS most often refers to a narrowing in the central canal of the vertebrae, the lateral recess, or the neural foramen. Changes to these can occur due to acquired degenerative spondylosis or spondylolisthesis, or more rarely due to conditions such as ankylosing spondylitis and space-occupying lesions, or congenital abnormalities. LSS can be classified according to anatomical location, etiology or severity of narrowing, though no validated classification has been published. The lack of concrete definition has caused difficulties in estimating the prevalence of LSS. Studies using community-based sampling has shown a prevalence of acquired LSS, defined as a narrowing of the central canal to ≤ 10mm in the anterior-posterior (AP) direction, of 7.3%. The prevalence has been shown to rise with age, from 4.0% affected at \< 40 years of age, to 14.3% amongst patients ≥ 60. No significant differences have been observed in overall prevalence according to gender, although there seems to be a slightly higher prevalence amongst elderly females than males. Although LSS is often asymptomatic, common symptoms of LSS include low back pain, which worsens with prolonged ambulation, lumbar extension and standing, and which is relieved by rest and forward flexion, as well as lumbar radiculopathy. Patients may also complain of poor balance, and physical examination findings may include a wide-based gait and abnormal Romberg results. Symptoms are thought to occur due to compression of microvascular structures in the nerves, allowing for neural ischemia and defects in nerve conduction, and venous pooling resulting in inadequate oxygenation and metabolite accumulation. Current treatment options for LSS range across both conservative and surgical management strategies. Conservative management has traditionally been regarded as first-line treatment, with a combination approach of physical therapy and pharmacological treatment with NSAIDs and analgesics. Epidural steroid injections have been used for symptom management, though with limited short and long-term benefits. Surgical management is often indicated in patients with ongoing pain despite attempts at conservative management for 3-6 months. Choice of surgical strategy to relieve the pressure on the neural structures depends on the anatomical location of stenosis and number of stenotic segments, as well as the intraoperative assessment of stability. The effect of surgical decompression on disability, leg pain and back pain has been widely evaluated, but studies of the effect on postural control are sparse. The present study aims to investigate the effect of surgical decompression of symptomatic lumbar spinal stenosis on postural control by assessment of sway measures before and after surgery. Activity levels: Physical activity (PA) has been demonstrated to be correlated to physical and mental wellbeing, having been shown to offer significant benefits including preventing and managing cardiovascular disease, cancer, and diabetes, as well as reducing symptoms of depression and anxiety. A dose-response relationship has been observed, and while all PA can be beneficial, higher levels can have more positive effects. Likewise, the negative consequences of sedentary behaviour are well established, hereunder increasing risks of metabolic and musculoskeletal disorders as well as all-cause mortality. As such, PA as both an intervention tool and as a measurement of effect has been becoming increasingly prevalent in the literature. It is currently recommended that adults should undertake regular PA, with a minimum of 150-300 min of moderate-vigorous physical activity (MVPA) every week. Adults who do not achieve this can be classified as physically inactive. It is worth keeping in mind though, that no definition of MVPA exists, as such a definition would need to be highly individualized. Efforts have been made to quantify PA in the context of research; the doubly labelled water (DLW) technique has been shown to be highly accurate in measuring total daily energy expenditure and is considered the gold standard when measuring activity levels. However, as this technique is expensive, time-intensive and imposes a high degree of subject interference, it is not practical for large-scale studies. Other measurements of activity have been developed and validated, including self-report questionnaires, self-report activity diaries, direct observation, and the use of devices such as accelerometers, pedometers, heart-rate monitors, and armbands. Among these, the use of accelerometers as an activity monitoring device has become increasingly prevalent due to the high frequency of measurements, large memory capacity, low subject interference and ability to differentiate between differing levels of activity. Accelerometer use has likewise been recommended as a clinical measurement of PA when undertaking intervention studies and has seen a rise in use in the field of orthopaedics. Patients with LSS are often classified as physically inactive due to the ambulatory limitations that symptomatic LSS can present with, and rarely meet the abovementioned recommendations for PA, despite evidence suggesting the benefits of PA for LSS patients. Previous studies have not been able to prove a significant effect of decompressive surgery on activity levels for LSS patients six months post-operatively, measured by accelerometer. However, while comparable studies on patients undergoing total hip arthroplasty likewise found no significant improvement in activity levels after six months, studies with longer follow-up, up to a year post-operatively, have been able to show an activity level comparable to healthy control individuals. Likewise, studies measuring activity levels on LSS patients undergoing decompressive surgery using pedometer readings have been able to show a significant increase in activity after 12 months. Activity monitoring device: The ActiGraph wGT3X-BT is a triaxial accelerometer, recording inertia in three planes at a sampling rate up to 100 Hz. A proprietary filter can be applied to eliminate artifacts due to movement not caused by human activity, and data is summed as a total activity count per minute, which can then be used to estimate PAEE and MVPA. The wGT3X-BT has been widely validated against gold standard measurements such as DLW, and in appropriate patient groups such as the elderly, and has been shown to be valid and reliable in assessing physical activity intensity. Rationale of the study: This study will be the first to correlate the effects of decompressive surgery in patients with symptomatic LSS with activity levels, and associated quality of life increases. Previous studies have been hampered by low power due to sampling size limitations, and short follow-up regimes, both of which this study seeks to manage through multi-centre collaboration and inclusion, and a follow-up regime spanning two years from the time of surgery. It is expected that the results of our study can facilitate an increased understanding of the role of activity when considering surgical management of symptomatic LSS patients, as well as enable targeted treatment of patients with LSS. Research question: Do elderly patients with symptomatic LSS, who have undergone decompressive surgery, show an improvement in activity level compared to pre-operative values?

The purpose of this study is to measure functional activity and stability in spinal deformity patients utilizing motion analysis testing and accelerometers.

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.

Lumbar spine surgery is a pivotal intervention for a variety of conditions affecting the lower back, such as degenerative disc disease, spinal stenosis, spondylolisthesis, and disc herniation. The first line of treatment in lumbar spine is usually conservative. If conservative treatment fails to lead to an improvement in symptoms in 3 to 6 months, surgical treatment can be considered as an option for symptom relief. Invasive therapies are considered when neurogenic claudication is present with positive findings from diagnostic imaging. Surgery has been shown to provide better outcomes for at least 4 years in terms of disability and pain with a narrowing of the benefits over time compared with conservative treatment.