Abstract
2 min read<sec> <title>BACKGROUND</title> Osteonecrosis of the femoral head (ONFH) often leads to disabling joint dysfunction. While early-stage treatments primarily focus on preventing collapse, a significant subset of patients enters a stabilized "survival with collapse" phase where functional limitation, rather than pain, becomes the primary factor compromising quality of life. Acupotomy has shown potential in enhancing hip function by releasing soft tissue adhesions and relieving muscular tension. However, conventional "blind" acupotomy poses inherent safety risks due to the deep anatomical location of the hip and its proximity to vital neurovascular structures. Ultrasound guidance offers a critical solution by providing real-time visualization to ensure procedural precision and safety. </sec> <sec> <title>OBJECTIVE</title> To assess the effectiveness of ultrasound-guided needle-knife therapy in enhancing joint function in ONFH patients achieving functional survival with collapse, and to develop a precise, standardized protocol for widespread clinical use. </sec> <sec> <title>METHODS</title> In this single-center, prospective, randomized controlled trial, 156 ONFH patients (ARCO stage III–IV) experiencing "survival with collapse" are randomized (1:1) into an experimental group (ultrasound-guided acupotomy) or a control group (conventional acupotomy). Both groups receive standardized basic rehabilitation. The primary outcome is the mean change in Harris Hip Score (HHS) from baseline to 6 months post-treatment. Secondary outcomes include TCM clinical efficacy scores, SF-36, Modified Ashworth Scale, and MRI-based grading of bone marrow edema and joint effusion. Safety is assessed via the incidence of neurovascular injury and other procedural complications. </sec> <sec> <title>RESULTS</title> Recruitment is scheduled from January 2024 to December 2026. As of the end of March 2026, 110 participants have been enrolled. The study is ongoing, with the completion of enrollment, follow-up, and data analysis anticipated by December 2026. </sec> <sec> <title>CONCLUSIONS</title> This trial will evaluate the clinical superiority of ultrasound-guided acupotomy over conventional "blind" techniques in improving hip function and safety for ONFH patients "surviving with collapse". If the hypothesis is validated, this protocol will provide high-level evidence for a standardized, minimally invasive intervention that may significantly improve joint mobility and postpone the need for total hip arthroplasty in this specific population. </sec> <sec> <title>CLINICALTRIAL</title> International Traditional Medicine Clinical Trial Registry, ITMCTR2024000617. Registered on September 18, 2024 (http://ccebtcm.org.cn). </sec>
Discussion(0)
No comments yet. Be the first to comment.