Effects of injecting micro-fragmented adipose tissue (MFAT) in the tendon-bone junction region during anterior cruciate ligament reconstruction on postoperative tendon-bone healing: a protocol for a randomised controlled trial in China.
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INTRODUCTION: Anterior cruciate ligament (ACL) injuries are among the most common sports-related injuries, often requiring surgical reconstruction to restore joint stability and function. However, inflammation and graft-to-bone healing remain critical challenges in postoperative recovery. Micro-fragmented adipose tissue (MFAT), rich in mesenchymal stem cells and anti-inflammatory factors, has shown potential in promoting tissue repair and reducing inflammation. This randomised controlled trial aims to evaluate the efficacy of MFAT injection in enhancing graft-to-bone healing at both the tibial and femoral sides and alleviating postoperative inflammation in ACL reconstruction. METHODS AND ANALYSIS: This is a prospective randomised controlled trial involving 70 patients with acute ACL injuries. Participants will be randomised into two groups: a standard ACL reconstruction group and an ACL reconstruction plus MFAT injection group. In the latter group, MFAT will be prepared from the infrapatellar fat pad and injected intra-articularly during surgery. All patients will follow a standardised postoperative rehabilitation protocol. Data will be collected at baseline and 3, 6 and 12 months postoperatively. Primary outcomes include graft maturity, assessed by signal-to-noise quotient on MRI at 6 and 12 months. Secondary outcomes include visual analogue scale scores, International Knee Documentation Committee scores and inflammatory marker levels (interleukin-6 and tumour necrosis factor-alpha). Additionally, complications such as infection and graft failure will be monitored during follow-up visits. ETHICS AND DISSEMINATION: This study has received ethical approval from the Ethics Committee of Weifang People's Hospital (approval number: KYLL20250105-5). Written informed consent will be obtained from all participants before enrolment. The findings will be published in peer-reviewed journals and presented at relevant conferences to contribute to evidence-based advancements in ACL reconstruction techniques. TRIAL REGISTRATION NUMBER: ChiCTR2500101018.