Bone Necrosis

Kienbock's disease, a condition involving ischemic necrosis of the lunate bone, has several surgical treatments depending on the disease stage and anatomical risk factors. This research focuses on stages II and III of the disease. Various surgeries aim to unload the lunate bone, restore its blood supply, or replace damaged parts, with most options working to maintain wrist structure, prevent disease progression, and reduce pain. This study evaluates the use of 3D printing models and personalized guides to plan different types of radial osteotomies tailored to patients' anatomical features. These osteotomies include radial shortening, closed wedge, and dorsolateral biplane closing osteotomies, chosen based on factors like cubitus minus and radial inclination angle. The procedures involve osteosynthesis with a plate on the distal radius to decompress and protect the lunate bone. Participants will undergo clinical and radiological evaluations before and after surgery, including assessments of wrist function, pain, grip strength, and range of motion. Radiographic measurements such as Lichtman classification, carpal height ratio, and various wrist angles will be monitored over 22 months. These evaluations aim to track changes related to the surgical planning aided by 3D models, with ongoing follow-up to assess outcomes and recovery.

Researchers are studying the use of the TRUMATCH Graft Cage to repair large segmental defects in long bones such as the humerus, femur, and tibia. This observational case series includes patients aged 18 and older who have these critical-sized bone defects requiring surgical fixation. The goal is to collect data over three years to better understand the healing process, complications, and recovery outcomes associated with this device. Participants who agree to join will receive the TRUMATCH Graft Cage during surgery to repair their long bone defects. The study focuses on collecting information about healing rates, complication rates, reoperation rates, pain levels, and the time it takes to return to normal activities. Data collection will occur over two years following the procedure to evaluate early outcomes of using the graft cage. During the study, participants will be monitored regularly to track their healing progress and any complications. Researchers will assess pain scores, need for additional surgeries, and functional recovery. The study will analyze this information after three years of data collection to provide insights on the graft cage's usefulness for managing complex long bone injuries. Participation involves follow-up visits and evaluations related to their surgical repair and recovery.

Researchers are studying men with metastatic castration-sensitive prostate cancer to see if taking oral acetate can increase the amount of a gut bacterium called Akkermansia muciniphila. The trial aims to confirm this increase compared to standard care and to assess how well patients tolerate oral acetate. The study also explores whether higher levels of this bacterium relate to better metabolic health and bone strength. This is an early phase 1 clinical trial sponsored by Western University. Participants are randomly assigned to one of two groups. One group takes an apple cider vinegar caplet daily, containing 143 mg with 36% acetic acid, for three months. The other group receives standard care without supplementation. The study includes follow-up periods lasting up to six months to monitor changes and side effects. Throughout the study, stool samples will be collected at multiple time points to measure Akkermansia muciniphila levels. Researchers will also evaluate various metabolic markers such as blood sugar, cholesterol, and insulin resistance, plus bone health indicators. Side effects and tolerability will be checked after three months. Participants are monitored over six months to assess both primary and secondary outcomes related to metabolism and bone health.

Researchers are evaluating the use of oral alendronate in adults who have sickle cell disease (SCD) along with osteonecrosis of the hip and/or shoulder. This phase 2, single-arm, open-label study aims to assess the safety, tolerability, and preliminary effectiveness of alendronate over a 6-month period. The study also investigates changes in bone health markers and quality of life related to pain in this population. Participants will receive oral alendronate 70 mg once a week for 24 weeks (6 months). This study involves one treatment group where all enrolled adults with SCD and osteonecrosis receive the study drug. Bone biomarkers will be collected from blood and urine samples at baseline, 3 months, and 6 months to monitor biological changes. During the study, participants will be monitored for recruitment and retention rates, treatment-emergent adverse events, and changes in pain impact using the Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me) questionnaire, assessed up to 28 weeks. The trial includes safety checks and collection of laboratory data at specific time points, with a goal to complete data analysis by May 2026. The total study duration for participants is approximately 6 months.

Researchers are evaluating whether artificial intelligence (AI) can help doctors detect broken bones, joint effusions, dislocations, and bone lesions more quickly and accurately in emergency room settings. This prospective, randomized, controlled trial compares traditional diagnostic methods to AI-assisted X-ray interpretation. The study also aims to see if AI can save time and reduce healthcare costs while improving clinical workflows in orthopedic emergency care. Participants will be assigned to one of two groups: one using standard physician interpretation of X-rays without AI assistance, and the other using AI tools (Aidoc or Gleamer BoneView) integrated into the hospital's imaging system to highlight potential injuries in real time. Both groups will receive standard X-ray imaging of injured arms or legs. The AI serves as a diagnostic aid, with physicians making final diagnoses. The study includes around 4,800 patients presenting with isolated extremity injuries or joint complaints. During the study, participants will undergo routine X-ray imaging and have their images reviewed with or without AI support depending on group assignment. Researchers will collect baseline demographic and clinical data and assess diagnostic accuracy, time to diagnosis, physician confidence, and cost efficiency. Diagnoses will be independently reviewed by experts to ensure accuracy. The study adheres to ethical guidelines and requires informed consent from participants. Results may inform future use of AI in emergency care settings.

Osteonecrosis of the femoral head (ONFH) is a painful condition where bone cells in the hip die, leading to the collapse of the femoral head and potentially arthritis. This condition often affects younger adults in their 20s and 30s, and joint-preserving treatments are important to delay or avoid joint replacement surgery. This study aims to compare core decompression surgery alone with core decompression combined with autologous bone marrow aspirate concentrate (BMAC) to see which method leads to better clinical and imaging results in early-stage ONFH. Participants will be randomly assigned to one of two groups: one receiving core decompression alone with a sham bone marrow aspiration, and the other receiving core decompression plus concentrated bone marrow aspirate injected into the hip bone. The bone marrow sample will be analyzed to understand the cells and biological pathways involved. Both procedures follow a standardized protocol to ensure consistency across participants. Throughout the study, participants will be monitored with routine surgical follow-ups and assessments including radiographs, MRIs, and questionnaires at multiple time points up to 24 months. Key outcomes measured include radiological progression of ONFH, pain levels using the Pain Visual Analog Scale, and time until treatment failure. Additional assessments of symptoms, function, quality of life, and mental and physical health will be collected at baseline, 6, 12, and 24 months. This study will help understand which treatment better preserves the hip joint in early ONFH cases.

Researchers are studying the pain-relief effects of liposomal bupivacaine plus bupivacaine compared to ropivacaine for Pericapsular Nerve Group (PENG) block in patients undergoing hip replacement surgery. The trial aims to determine if liposomal bupivacaine plus bupivacaine provides better pain control, longer duration of relief, reduced opioid use, and higher patient satisfaction while monitoring safety. This is a randomized, double-blind, active-controlled Phase 4 study sponsored by Huazhong University of Science and Technology. Participants receive either liposomal bupivacaine plus bupivacaine or ropivacaine as a local anesthetic for the PENG block under ultrasound guidance. All undergo hip replacement surgery under spinal anesthesia. The study compares analgesic efficacy, pain relief duration, opioid consumption, and safety profiles between the two interventions within 72 hours after surgery. During the trial, pain intensity, opioid use, and complications are assessed multiple times within 72 hours following surgery. Researchers also track time to first rescue analgesic, incidence of complications or adverse events up to 90 days post-surgery, and the duration of hospital stay for about one year. The main outcome measured is overall opioid consumption within 72 hours after surgery, with safety and patient satisfaction also evaluated throughout the study period.

Researchers are exploring the genetic causes of muscle diseases, especially those occurring alongside inherited bone disorders. This observational study aims to better understand how muscle and bone diseases that run in families affect tissue function and metabolism over time. The research uses a non-invasive technology called Diffuse Optical Spectroscopy to study these tissue changes. Diffuse Optical Spectroscopy is a quick and painless device developed at the University of California, Irvine. It measures concentrations of blood, water, and fats in tissues by shining infrared light on the skin using a probe placed on areas such as the calf, bicep, or head. The probe is held in place gently by hand or secured with medically approved wraps or tapes, leaving small marks on the skin to ensure consistent placement during repeated measurements. The technique involves no radiation and may include placing a detector directly on the skin in some cases. Participants will have the spectroscopy probe applied to specific body areas to gather data on tissue physiology. The study monitors muscle disease over a one-week period using these measurements. The process is safe, with no radiation exposure, and does not involve treatment but focuses on observation. Participation involves a series of painless measurements and may include family members with muscle or bone disorders. The total study duration and follow-up depend on individual circumstances.

Researchers are observing clinical and radiological outcomes of the Medacta Shoulder System in patients with various shoulder conditions including primary and secondary osteoarthritis, rotator cuff tear arthropathy, rheumatoid arthritis, avascular necrosis, fractures, and revision of shoulder arthroplasty. This post-marketing surveillance study evaluates how well the system performs over time in real-world settings. The study involves monitoring patients who have received the Medacta Shoulder System implant. Outcomes assessed include implant survival rate up to 10 years, clinical and functional shoulder scores at 1, 2, 5, and 10 years, radiographic evaluations for implant positioning and signs of loosening, patient quality of life, and any adverse events related to the implant. Participants will be followed for up to 10 years with scheduled assessments including clinical exams, shoulder function scoring, imaging studies, and patient questionnaires. Researchers will track the implant's durability and patient health over time to understand long-term outcomes and safety. The total participation period can last a decade to capture comprehensive data.

Researchers are evaluating the use of tissue-engineered bone made from commercial decalcified bone scaffolds combined with a patient's own bone marrow mesenchymal stem cells to treat early non-traumatic avascular necrosis of the femoral head. This condition progresses quickly, often leading to femoral head collapse within 1 to 4 years. Early intervention aims to preserve the femoral head and improve outcomes compared to current treatments like core decompression and bone grafting, which have limitations including donor site damage and limited biological activity. The study uses tissue engineering to create a composite of seed cells, growth factors, and scaffold materials that are transplanted to the bone defect site. This method provides structural support and promotes bone and blood vessel regeneration. The intervention involves using tissue-engineered bone with autologous bone marrow mesenchymal stem cells for femoral head repair. The treatment is applied during surgery, and the study will monitor its effects over time to assess clinical benefits and safety. Participants will be assessed before surgery and followed up at multiple time points including 1 month, 2 months, 3 months, 6 months, and one year after the operation. Evaluations will include effectiveness measures of the tissue-engineered bone in treating femoral head necrosis and safety monitoring. The study involves clinical examinations, imaging, and other tests to track bone repair and function. The total participation duration for each patient spans at least one year after surgery to observe long-term outcomes.