Osteonecrosis involves the loss of blood supply to bone tissue, leading to bone death and structural collapse. Clinical trials for osteonecrosis assess new treatments that aim to halt or slow bone damage, as well as interventions to improve pain mana...
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Found 94 Actively Recruiting clinical trials
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Kienbocks 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.
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Researchers are evaluating the safety and effectiveness of MACI compared to arthroscopic microfracture surgery in treating young participants aged 10 to 17 years who have symptomatic cartilage or bone-related defects in the knee. This Phase 3 clinical trial involves 45 participants who are randomly assigned to receive one of these two treatments. The study explores which approach might better improve knee pain and function over time. Participants undergo an initial screening visit including an arthroscopy to confirm eligibility. During this procedure, cartilage lesion size is measured, and a biopsy is taken for cell processing. Those assigned to MACI will receive a one-time implantation of cultured cartilage cells on a collagen membrane within 12 weeks following screening. Those assigned to microfracture undergo the procedure during the initial arthroscopy. Participants follow a recommended rehabilitation plan after treatment. Participant involvement spans two years after treatment, during which researchers monitor recovery and knee function. Assessments include measuring improvements in pain and sports-related activities using the KOOS-Child questionnaire at baseline and at 52 and 104 weeks. Compliance with rehabilitation and long-term safety are also tracked, ensuring thorough evaluation of treatment outcomes.
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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.
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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.
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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.
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Researchers are evaluating the use of oral alendronate in adults aged 18 to 80 years who have sickle cell disease SCD and osteonecrosis affecting the hip or shoulder bones. This phase 2, single-arm, open-label study aims to assess safety, tolerability, and preliminary effectiveness by measuring pain impact and bone biomarker changes during treatment. The study plans to recruit 24 adults with SCD from a medical center between 2024 and 2025. Participants will take oral alendronate 70 mg once a week for 24 weeks 6 months. Bone biomarkers will be measured through serum and urine samples at the start, 3 months, and 6 months after starting the medication. The study will also track recruitment and retention rates and monitor adverse events throughout the 28-week period. During the study, participants will complete the Adult Sickle Cell Quality of Life Measurement System ASCQ-Me Pain Impact questionnaire at baseline, 3 months, and 6 months. Researchers will collect blood and urine samples every two months to assess bone turnover, inflammatory, and vascular adhesion biomarkers. Safety and tolerability will be monitored through participant reports. The study expects to complete its primary data analysis by May 2026.
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Researchers are evaluating alveolar ridge preservation techniques in patients undergoing maxillary molar extractions to address bone loss challenges that affect dental implant success. The study compares immediate versus delayed bone grafting approaches to reduce bone and soft tissue loss after tooth extraction. This research is conducted in a multidisciplinary academic setting integrating surgical and prosthetic planning with digital workflows to improve implant positioning and patient outcomes. Participants receive either immediate grafting using Ossix Plus membrane and bone graft at the time of extraction or delayed grafting performed during implant placement using Ossix Agile membrane and bone graft. All materials used are FDA-approved and commercially available. The study occurs in a controlled clinical environment ensuring coordinated care and follow-up. During the study, participants are monitored through various visits after implant placement at 2 weeks, 6 months, and 1 year. Researchers will assess patient-reported outcomes using the Oral Health Impact Profile-14 questionnaire and compare clinical and radiographic measures such as bone thickness, soft tissue dimensions, sinus pneumatization, bone height and width, and marginal bone levels. The study aims to tailor treatment approaches while minimizing patient discomfort and improving implant therapy success over time.
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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.
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This trial studies adults aged 18 and older who need a tooth extraction to see if using Beta-Tricalcium Phosphate -TCP helps preserve the bone volume in the area compared to natural healing. The research compares sockets treated with -TCP to those left to heal naturally, aiming to understand if -TCP better maintains ridge volume after extraction. Participants who have a tooth extraction will receive either grafting with Neocement Inject P Beta-Tricalcium Phosphate or natural healing without grafting. After the extraction, those in the treatment group will have the socket grafted with the -TCP device. Bone changes are then monitored over a six-month healing period. During the study, participants will undergo Cone Beam Computed Tomography CBCT and intra-oral scans immediately after extraction and again after six months. These scans measure horizontal and vertical bone loss as well as bone density. The primary outcome is the change in alveolar ridge volume from enrollment to six months after treatment, ensuring detailed monitoring of bone preservation.
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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.
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