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NCT07545616
Osteonecrosis of the femoral head (ONFH) presents a rapidly progressive natural disease course. Femoral head collapse may occur within two years, ultimately necessitating total hip arthroplasty and imposing a heavy medical and economic burden on patients. Early intervention can significantly improve the long-term prognosis of ONFH. However, due to the lack of validated biomarkers for early diagnosis, the early diagnostic rate remains low, with a primary diagnostic rate of merely 68.43% at the first visit, accompanied by a high rate of misdiagnosis. This project intends to collect blood samples from patients diagnosed with ONFH and suspected cases in the orthopedic outpatient department of a tertiary Grade A hospital. Diagnostic and differential diagnostic tests will be adopted to evaluate the clinical application value of previously reported candidate biomarkers, so as to screen out biomarkers with excellent diagnostic validity and reliability. Meanwhile, clinical data will be collected to identify independent risk factors, and a multi-dimensional integrated diagnostic model will be further established. The research findings are expected to provide solid data support, theoretical basis and technical reserves for the early prevention, early diagnosis and individualized intervention of osteonecrosis of the femoral head.
NCT07471880
This is a multicenter, randomized (similar to drawing lots, where the treatment you receive is not chosen by you or the researchers), controlled, blinded (the three dose groups of the investigational drug are blinded, meaning neither you nor the blinded researchers will know which dose you are receiving) clinical study to evaluate the efficacy, safety, and PK/PD profiles of RAB001 for injection in patients with early-stage non-traumatic osteonecrosis caused by long-term glucocorticoid use. A parallel-group enrollment design will be used, with a total of approximately 160 subjects expected to be enrolled (High-dose A: 1200 μg/kg；Medium-dose B: 750 μg/kg ；Low-dose C: 400 μg/kg): Control group (D: Alendronate Sodium Tablets (Fosamax) 70 mg orally once weekly) = 40 cases . If you agree to participate in this trial, you will have a 25% chance of being assigned to one of the groups mentioned above. Supportive treatment: Calcium (recommended dose: 1000-1200 mg/d) + Vitamin D (recommended dose: 600-800 IU/d). The study physician may choose the appropriate dosage of calcium and vitamin D based on the subject's specific conditions. Primary endpoints: 1. . Change in femoral head necrotic lesion volume at 48 weeks (MRI) 2. . Change in hip function score at 48 weeks (HHS, Harris Hip Score)
NCT06123481
Osteonecrosis of the femoral head (ONFH) is a debilitating musculoskeletal disease that is characterized by localized death of bone cells and associated cellular elements within the subchondral bone. If it progresses, it results in the collapse of the femoral head (ball part of the hip) giving rise to secondary arthritis. This condition is associated with marked pain and loss of function, often necessitating a joint replacement. Due to the relatively young age of onset of ONFH (often in 20s and 30s), there is great interest in utilizing joint-preserving procedures prior to the need for joint replacement. Joint-preserving procedures include core decompression (CD) with and without bone grafts or cells, vascularized and non-vascularized bone grafting, as well as osteotomies. Inconsistent results for each of these procedures have been reported and there are no Clinical Practice Guidelines or medical community consensus opinions regarding the treatment of early-stage ONFH. The hypothesis to be tested is "Participants who have early-stage ONFH undergoing CD augmented with autogenous bone marrow aspirate concentrate will have better clinical and radiological outcomes than CD alone." This multi-center randomized controlled trial for early-stage ONFH is prospective and controlled for participant stage (only early-stage pre-collapse individuals) and surgical technique. Participants will be evaluated as per routine surgical follow-up, and at 6 months (telemedicine), 1- and 2- years using radiographs, MRIs, and questionnaires. This project will also explore the scientific basis for success vs. failure in individuals who have osteonecrosis, and have different demographics and bone marrow aspirate cell profiles.
NCT01544712
In stage 3 Osteonecrosis (ON) of the femoral head, a beneficial effect of bone marrow grafting was reported with a reduction of the functional evolution and the necessity of a total prosthesis placement in a non-controlled retrospective trial. Based on this experience, the investigators would like to start a randomized controlled double blind study on the effect of autologous implantation of autologous bone marrow cells into the necrotic lesion of stage 3 ON of the femoral head.