Joint Fusion

Researchers are studying whether a continuous intravenous lidocaine infusion after major reconstructive spinal surgery can reduce the risk and severity of postoperative delirium and lessen opioid-related side effects in elderly patients. Postoperative delirium is common after non-cardiac surgery and linked to poor outcomes, with poor pain control being a modifiable risk factor. This study is a randomized, double-blinded, placebo-controlled trial involving 60 patients undergoing major elective spine surgery involving more than three levels of instrumentation and fusion. Participants will be randomly assigned to receive either a lidocaine infusion at 1.33 mg/kg/hr based on adjusted body weight or a placebo (D5 water) intravenously for 48 hours following surgery. Anesthetic management during surgery is standardized with total intravenous anesthesia including propofol, lidocaine, magnesium, fentanyl, and sevoflurane. The lidocaine infusion or placebo begins postoperatively before discharge from the post-anesthetic care unit or upon intensive care unit arrival. During the study, participants will be monitored for the incidence and severity of postoperative delirium from 24 hours after starting the infusion to 3 days post-surgery. Researchers will also assess opioid use, pain scores, opioid-related side effects, analgesic satisfaction, functional recovery using surveys and physical therapy participation, time to discharge, and cognitive function up to 3 months. Safety and tolerability of lidocaine will be closely observed, with continuous monitoring during and after surgery. The total follow-up includes assessments up to hospital discharge and longer-term functional outcomes at 3 months.

The trial investigates the real-world use of INFUSE174 Bone Graft for patients in Korea who require lumbar fusion surgery due to degenerative disc disease. It is a prospective, observational, multi-center post-market surveillance study designed to collect data on the safety and effectiveness of this commercially available device used as intended. The study aims to follow over 600 cases during a four-year period after approval in Korea. Participants in this study are patients treated with INFUSE174 Bone Graft via anterior (ALIF) or oblique (OLIF) lumbar interbody fusion techniques. The device is approved for use as a substitute for autogenous bone graft in patients with degenerative disc disease who have undergone at least six months of nonoperative treatment. The study observes patients who have received this device according to standard care without altering their treatment. During the study, patients will be monitored for at least 12 months after surgery. Researchers will collect information about any adverse device effects and assess fusion status within this period. Clinical outcomes such as disability index (ODI), pain levels (VAS), and neurological success will be recorded at multiple timepoints including 6 weeks, 3 months, 6 months, and 12 months after surgery. This comprehensive follow-up aims to provide important real-world data on patient recovery and device performance.

This research aims to evaluate how well patients with various musculoskeletal conditions follow personalized home-based exercise programs prescribed by their physicians. It focuses on patients with degenerative, orthopedic, or neurological disorders undergoing rehabilitation. The study seeks to identify differences in adherence across these groups and explore factors such as demographics, clinical status, psychosocial elements, and physical function that might influence exercise compliance. Participants will receive customized home exercise programs designed by physical therapy and rehabilitation physicians based on their specific clinical needs. These exercises complement clinic-based treatments and are tailored to individual conditions within three subgroups: chronic degenerative disorders, post-operative orthopedic rehabilitation, and neurological rehabilitation following conditions like stroke or hemiplegia. The home programs will last six weeks, with clear instructions and printed materials provided to support correct performance. During the study, patients' adherence and clinical progress will be assessed at the beginning and end of the six-week program using standardized tools such as the Exercise Adherence Rating Scale, Beck Depression Index, Visual Analog Scale for pain, Barthel Index for daily living activities, Tampa Kinesiophobia Scale, and Health Assessment Questionnaire. Researchers will monitor mood, functional status, pain levels, and fear of movement to understand adherence patterns. The study will also evaluate patients' satisfaction and factors influencing their commitment to the home exercises, aiming to improve future rehabilitation strategies.

Researchers are comparing the pain relief effects of a multiple mid-transverse process to pleura (MTP) block with patient-controlled analgesia (PCA) using morphine in adults with idiopathic scoliosis undergoing posterior spinal fusion surgery. The study addresses the challenges of managing postoperative pain and hospitalization length in this group. Regional anesthesia techniques like epidural analgesia and paravertebral blocks, enhanced by ultrasound guidance, have become important in multimodal pain management. The MTP block and erector spinae plane (ESP) block are newer methods being evaluated for postoperative pain control. Participants are randomly assigned to one of two groups. One group receives multiple MTP blocks after anesthesia induction. The other group uses intravenous PCA with morphine, starting with a loading dose before surgery ends, followed by patient-controlled doses with specified lockout intervals and background infusion rates. This randomized, double-blind trial compares these two pain management approaches during and after surgery. Throughout the study, researchers monitor pain levels 24 hours after surgery as the primary outcome. They also track intraoperative fentanyl use, timing of first rescue analgesia, total morphine use, blood pressure and heart rate every 15 minutes during surgery, patient satisfaction, and any complications within 24 hours postoperatively. The overall goal is to better understand and improve pain control strategies in scoliosis surgery patients.

This research trial focuses on children and adolescents aged 8 to 18 years undergoing surgery to correct idiopathic scoliosis by posterior spinal instrumentation and fusion involving at least 6 vertebral levels. The study evaluates whether adding Aprepitant to the standard treatment can better prevent nausea and vomiting after surgery. It is a randomized, controlled trial aiming to reduce post-operative nausea and vomiting (PONV) and related symptoms like headache and pain, with careful monitoring of any side effects. Participants will receive either two doses of 40 mg Aprepitant syrup or two doses of a placebo (dextrose syrup). The first dose is given on the morning of surgery and the second on the morning after surgery (post-op day 1). This treatment is tested alongside the usual multimodal therapy used to prevent nausea and vomiting during and after surgery. During the study, researchers will track the need for anti-nausea rescue medication and record symptoms such as vomiting, headache, pain, flatus, bowel movements, and itching from the end of surgery until discharge, which may last up to 10 days. They will also watch for any treatment-related side effects. Participants will be closely monitored during their hospital stay to assess the effectiveness and safety of adding Aprepitant to standard care after scoliosis surgery.

Researchers are evaluating surgical treatment called arthrorisis of the subastragalus joint using a polymeric implant to address flexible flatfoot in children aged 8 to 14 years. This condition involves joint deformity causing flat feet, and the study aims to analyze clinical and radiographic outcomes over time during growth. The trial is a prospective observational study involving 55 patients to better understand the treatment's effects. The surgical procedure uses a polymeric endorthesis designed to restore proper alignment between the astragalus and calcaneus bones and maintain this correction over time. The goal is to allow natural bone remodeling along growth lines, usually within a few years. This study tracks patients undergoing this specific surgery without comparing other treatments. Participants will be monitored regularly with measurements of Meary's angle at baseline and multiple follow-up points up to 72 months after surgery. Additionally, the American Orthopaedic Foot & Ankle Society (AOFAS) scores will be assessed at the same intervals. These evaluations help assess the joint alignment and foot function over time. The study will continue collecting data and monitoring outcomes until 2028.

Researchers are evaluating two surgical techniques for treating cervical degenerative disc disease (CDDD), which causes symptoms like radiculopathy and myelopathy. The study compares anterior cervical discectomy with fusion (ACDF), a common surgery that fuses spinal segments, to anterior cervical discectomy with arthroplasty (ACDA), which preserves motion at the operated segment. The main goal is to determine which technique is more cost-effective over the long term, considering both health outcomes and societal costs, as no clear consensus currently exists on this matter. Participants will be randomly assigned to receive either ACDF or ACDA surgery. Both procedures begin with removing the damaged disc through an anterior approach. In ACDF, a cage is implanted to fuse the vertebrae, while in ACDA, a cervical disc prosthesis is placed to preserve motion. These interventions can be performed at a single or multiple spinal levels. Postoperative care includes wound closure and drain placement as needed. During the study, participants will be followed for up to four years with assessments at baseline and every six months. Researchers will collect clinical and radiological data, including measures of neck disability, pain scales, anxiety and depression levels, and neurological function. They will also evaluate the development of clinical adjacent segment pathology (CASP) and perform a process evaluation related to the surgical treatment. The focus is on both the effectiveness and costs associated with each surgical technique from a societal viewpoint.

This research aims to assess fusion rates and cervical spine alignment following posterior cervical arthrodesis surgeries supplemented with cervical interfacet spacers (CIS). These procedures are done for conditions like degenerative cervical spondylosis, deformity, tumors, or trauma affecting the cervical spine. The study focuses on how CIS, a device placed under tension in the spine, may improve bone fusion and potentially reduce complications such as nerve root compression and C5 palsy. Participants will undergo posterior cervical fusion surgery involving three or more spinal segments in the neck and upper thoracic region, with CIS used to support the fusion. Data will be collected from medical records, including demographic details, surgical information, clinical status before surgery, and imaging results. Additionally, participants will have a non-standard CT scan two years after surgery to evaluate fusion and spinal alignment. Throughout the study, researchers will collect and review various data for up to two years after surgery, including X-rays, CT scans, and patient-reported outcomes on pain and function. Neurological events will also be monitored. The primary outcomes are the rate of cervical fusion and spinal alignment after two years. Secondary outcomes include pain scores, disability indexes, quality of life measures, and any neurological complications. This detailed follow-up helps understand the long-term effects of CIS in cervical spine surgery.

Researchers are evaluating the use of 3D digital surgery compared to conventional 2D surgery in traumatology and orthopedic surgery. This study aims to assess the clinical benefits and cost-effectiveness of digital surgery, which uses patient-specific instruments and personalized implants to potentially improve surgical outcomes and reduce complications. The trial focuses on three surgical procedures: distal radius osteotomy, acetabular arthroplasty, and spinal arthrodesis. Participants are randomly assigned to either the 3D digital surgery group, which involves 3D surgical planning, personalized surgical guides, and implants made through 3D printing, or the conventional surgery group, which uses 2D imaging, free-hand surgery, and generic implants. The surgery types studied are radius osteotomy, acetabular arthroplasty, and spinal arthrodesis. This is a prospective, multi-center, randomized clinical trial with double masking. Participants will undergo CT scans before surgery and 21 days after surgery to measure implant accuracy and positioning. Pain, quality of life, and functionality are assessed before surgery, 21 days after, and 12 months after surgery using specific questionnaires. Surgical time, materials used, fluoroscopy time, complications, and follow-up visits are also monitored. The study aims to provide evidence on both clinical outcomes and economic impact, with a planned end date in 2027.

Researchers are evaluating the safety and performance of the Zimmer Nexel Total Elbow device used in primary or revision total elbow replacement surgeries. The study aims to confirm these aspects by analyzing standard scoring systems, X-rays, and records of any adverse events. It focuses on conditions such as elbow joint destruction, post-traumatic lesions, arthritis, instability, and fractures that impact elbow function. The study includes two groups: patients who have already undergone elbow replacement using the Nexel Total Elbow and those scheduled to receive it. The device's safety is monitored by tracking adverse event frequency, while its performance is assessed by measuring pain, function, implant survival, patient health, and radiographic success. Both retrospective and prospective data are collected based on surgical details and follow-up evaluations. Participants will undergo scheduled follow-up visits to evaluate their pain levels, functional abilities, and elbow health through physical exams and imaging. Researchers will monitor device survival over 10 years and track any complications or adverse events. The total duration of participation varies depending on whether the patient is in the retrospective or prospective group, with ongoing assessments to ensure safety and performance.