The Effect of Platelet-rich Fibrin on the Regeneration of Patellar Ligament Defects and the Functional Recovery of Patients After Anterior Cruciate Ligament Reconstruction of the Knee
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Proportion of participants without anterior knee sensory deficit at the donor site
研究概览
简要总结
Pilot, single-center, non-randomized, parallel-group clinical study designed to assess whether intraoperative application of autologous platelet-rich fibrin (PRF) at the bone-patellar tendon-bone (BPTB) donor site reduces postoperative anterior knee sensory deficit after anterior cruciate ligament (ACL) reconstruction in competitively active male athletes. Planned enrollment is 53 participants allocated to a PRF cohort or a standard-care cohort. The primary outcome is the proportion of participants without anterior knee sensory deficit at 12 months post-surgery.
详细描述
Background: Sensory deficit around the BPTB donor site is a recognized complication after ACL reconstruction and may affect patient satisfaction and functional recovery. PRF is an autologous bioregenerative product with potential to support soft-tissue healing.
Objective: To determine whether PRF application at the donor site reduces anterior knee sensory deficit compared with standard surgical care.
Design and Participants: Single-center, prospective, pilot, non-randomized study with two parallel cohorts (PRF vs standard care). Competitively active male athletes meeting prespecified eligibility criteria are followed at 4, 8, and 12 months post-surgery. Recruitment window: January 2022 to January 2023.
Interventions: In the PRF cohort, PRF is prepared intraoperatively and applied to the donor site per manufacturer protocol; the comparator cohort receives standard closure without PRF.
Assessments:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 18-40 years
- •Isolated anterior cruciate ligament rupture confirmed by MRI and clinical examination
- •Planned ACL reconstruction with BPTB autograft
- •Written informed consent provided
排除标准
- •Previous knee surgery on the affected knee
- •Associated ligament injuries requiring additional reconstruction
- •Significant cartilage damage (Outerbridge grade III-IV beyond donor site changes)
- •Systemic disease affecting wound healing (e.g., diabetes mellitus, autoimmune disease)
- •Active infection
- •Refusal or inability to provide informed consent
研究组 & 干预措施
PRF Group
Patients undergoing ACL reconstruction with a bone-patellar tendon-bone (BPTB) autograft, with platelet-rich fibrin (PRF) applied at the donor site (n=24)
干预措施: Platelet-rich fibrin (PRF) (Biological)
Control Group
Patients undergoing ACL reconstruction with a BPTB autograft, treated with standard closure without PRF (n=29)
干预措施: Standard Closure (Control) (Procedure)
结局指标
主要结局
Proportion of participants without anterior knee sensory deficit at the donor site
时间窗: 12 months post-surgery
Sensory function assessed over a predefined 9-point area lateral to the surgical scar; deficit coded as 1 if \>3 points are reported as "no or altered touch," otherwise 0. Assessment performed with eyes closed; contralateral knee used for reference if uncertain. Measure Type \& Units: Percentage of participants (%)
次要结局
- International Knee Documentation Committee (IKDC) Subjective Knee Form score (0-100; higher scores indicate better function)(Baseline, 4, 8, and 12 months post-surgery)
研究者
Darko Milovanovic
Principal Investigator, University Clinical Center of Serbia, Docent, Faculty of Medicine, University of Belgrade
University of Belgrade