Osteonecrosis

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 evaluating the effectiveness and safety of MACI compared to arthroscopic microfracture for treating young patients aged 10 to 17 years who have symptomatic cartilage or osteochondral defects in the knee. This phase 3 clinical trial seeks to understand which treatment better improves pain and function related to these knee defects. This study randomly assigns a total of 45 patients into two groups: 30 will receive a single treatment with MACI, which involves autologous cultured chondrocytes on a porcine collagen membrane, and 15 will receive arthroscopic microfracture treatment during a screening arthroscopy. Patients assigned to MACI return within 12 weeks for the cell implantation surgery and follow a recommended rehabilitation program. The trial lasts for two years after treatment to monitor outcomes. Participants undergo a screening arthroscopy to confirm eligibility and have a cartilage biopsy taken before treatment. Researchers will monitor cartilage lesion size, compliance with rehabilitation, and measure improvements in knee pain and function using KOOS-Child scores over 104 weeks. Safety and efficacy are tracked carefully throughout the study period.

Researchers are evaluating a new approach to improve care coordination between hospitals and primary care for patients aged 75 or older who have suffered a hip fracture. The study focuses on osteoporosis treatment using zoledronic acid infusions combined with vitamin D and calcium supplements to prevent further fractures. The trial aims to test if ambulant nurses assisting general practitioners (GPs) can increase the number of patients receiving recommended annual zoledronic acid infusions over three years after their fracture. Participants receive an initial infusion of zoledronic acid 5 mg at the hospital after their femoral neck fracture and are then followed in one of two ways based on their region. In intervention regions, ambulant nurses support GPs with administering zoledronic acid yearly for three years. In control regions, patients receive usual care where GPs are responsible for follow-up and annual infusions guided by discharge summaries. The study is designed as a cluster randomized controlled trial with regions assigned to intervention or control groups. During the study, patients from both groups are asked to complete a questionnaire after one year, reporting if they received zoledronic acid as recommended. The main outcome is whether patients are offered treatment at the one-year follow-up. The trial includes safety monitoring and data collection over three years, with an estimated total of 200 patients to account for mortality. It seeks to establish practical procedures for nurse-assisted osteoporosis treatment in primary care settings to improve patient care continuity after hospital discharge.

Researchers are evaluating the long-term outcomes of the ACE Acetabular Cup System, a device used in total hip replacement surgery. This procedure replaces both the hip ball and socket to relieve pain and help patients return to normal activities. The study aims to monitor the safety and performance of this CE-marked device over 10 years by assessing clinical, functional, and radiological results in patients with hip disease. The ACE Acetabular Cup System offers three options for socket liners: ceramic, polymer, or dual mobility, allowing surgeons to choose the best fit for each patient. Participants in the study have received a primary elective total hip replacement using this system combined with a JRI femoral stem and head. The study is observational and follows patients over a decade to gather data on device function and patient health. Participants will be followed through questionnaires, reviews of X-rays, and monitoring of any complications. Key measurements include the Oxford Hip Score at 3 years post-operation, along with implant survivorship and other hip function assessments at multiple time points up to 10 years. Radiological assessments will also be conducted at 1, 5, and 10 years. This comprehensive follow-up helps researchers understand how well the device performs long-term and supports patient safety.

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 alveolar ridge preservation (ARP) in the posterior maxilla after the extraction of maxillary molars to address bone and soft tissue loss that occurs following tooth removal. This study focuses on improving implant therapy by examining whether immediate or delayed grafting better supports bone and soft tissue maintenance, considering challenges like sinus pneumatization and dimensional changes in the extraction site. The research is conducted by Virginia Commonwealth University using a multidisciplinary model combining periodontics and prosthodontics expertise. The study compares two grafting approaches: immediate grafting using Ossix Plus membrane and Ossix bone graft right after tooth extraction, and delayed grafting performed at the time of implant placement using Ossix Agile membrane and Ossix bone graft if needed. Both materials are FDA approved and used according to manufacturers' instructions in standard care. Treatment plans are personalized based on preoperative analysis to reduce the number of grafting procedures while aiming for ideal implant positioning. Participants will be followed up at 2 weeks, 6 months, and 1 year after implant placement to assess patient-reported outcomes using the Oral Health Impact Profile-14 (OHIP-14) and clinical and radiographic measures such as bone thickness, soft tissue thickness, sinus pneumatization, bone height and width, and marginal bone levels. The study includes thorough surgical and prosthetic planning, digital workflows, and continuous patient monitoring to evaluate the clinical and economic effectiveness of ARP strategies in a controlled academic setting.

Researchers are evaluating changes in the labial bone plate after immediate implant placement in Type II extraction sockets using two different xenograft materials along with a de-epithelialized free gingival graft in the esthetic zone. This randomized clinical trial aims to compare the effects of these grafting materials on bone preservation and implant success. The study addresses concerns about bone changes following tooth extraction and immediate implant placement, focusing on maintaining bone and soft tissue structure in the front upper jaw area. Participants will undergo immediate implant placement after tooth extraction in the esthetic zone. They will be randomly assigned to one of two groups receiving defect grafting with either Medpark S1 xenograft or bio-Oss xenograft. Both groups will also receive a de-epithelialized free gingival graft during the procedure. The interventions involve placing the implant and grafting material in the extraction socket to support bone and tissue preservation. During the study, clinical evaluations and standardized radiographic assessments using CBCT scans will be conducted to measure changes in labial bone plate thickness and peri-implant bone stability. Implant success will be monitored over a follow-up period of six months. Researchers will assess outcomes such as bone thickness changes and peri-implant mucosal levels, ensuring participants' compliance and safety throughout the trial.

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 conducting a multicenter prospective cohort study to evaluate the clinical results and safety of autologous osteoperiosteal transplantation in patients with severe osteochondral lesions of the talus (OLT). The study aims to determine whether this procedure provides good clinical outcomes and fewer postoperative complications when treating severe OLT. This study is sponsored by Peking University Third Hospital. Participants will undergo autologous osteoperiosteal transplantation, where a bone graft is taken from the iliac crest and transplanted to repair the lesion in the talus. The surgical procedure involves drilling and debriding the cystic lesion before grafting bone tissue. The study includes clinical follow-up visits at 3, 6, 12, and 24 months after surgery, with imaging examinations such as CT and MRI performed before surgery and at 12 and 24 months post-operation. During the study, participants will complete ankle function assessments including the Foot and Ankle Outcome Score (FAOS) at multiple time points up to 24 months after surgery. Additional measures include the American Orthopedic Foot and Ankle Society Score, Visual Analogue Scale for pain, Ankle Activity Score, and cartilage repair imaging assessments. Complications will be monitored up to 48 months after surgery to evaluate safety and donor-site morbidity. Participants will be closely followed to assess recovery and clinical outcomes over this period.