Comparison of Functional Outcomes Following Arthroscopic ACL Reconstruction With Peroneus Longus Autograft With and Without Intra-articular Platelet-Rich Plasma Injection: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- KOOS4 score
研究概览
简要总结
This prospective RCT investigates if a single 4 ml intra-articular PRP injection improves knee function after ACL reconstruction using peroneus longus autograft. In Pakistan's resource-limited context, 88 patients (18-50 years) with isolated ACL tears receive either PRP or saline during surgery, then randomized equally. KOOS4 scores compared at 3, 6, and 12 months via ANCOVA (adjusted baseline, α=0.05). Positive results could establish affordable enhancement for recovery and guide practice in similar settings.
详细描述
Anterior cruciate ligament (ACL) injuries impair knee function, particularly in young athletes, with many failing to regain pre-injury performance post-reconstruction (ACLR). Peroneus longus autografts offer comparable strength to traditional grafts with reduced donor site morbidity, but early recovery remains challenging. Platelet-rich plasma (PRP) may enhance graft healing, yet its efficacy with peroneus longus autografts is understudied, especially in resource-limited settings like Pakistan, where costly PRP methods are impractical. This prospective randomized controlled trial (RCT) evaluates whether a single intra-articular PRP injection (4 ml, 2 ml per femoral/tibial tunnel) improves functional outcomes in ACLR with peroneus longus autograft. The hypothesis is that PRP will lead to superior knee functions. The study aims to compare KOOS4 scores at 3, 6, and 12 months between PRP and control groups. Eighty-eight patients (44 per group) aged 18-50 with isolated ACL tears will be randomized (1:1) to receive 4 ml PRP (from 15-20 ml blood, single-spin centrifugation at 3500 rpm) or saline during surgery at Lahore General Hospital. Assessments at baseline, 3, 6, and 12 months will use validated KOOS4 questionnaires, integrated into clinic visits to ensure low dropout (10%). Data will be analyzed using analysis of covariance (ANCOVA) for KOOS4 scores (α = 0.05) in SPSS, adjusting for baseline differences. Improved KOOS4 scores with PRP could validate a cost-effective approach, enhance recovery and inform clinical guidelines in resource-constrained settings, ultimately improving patient outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 50 years. Diagnosis of a primary, complete ACL tear requiring reconstruction. Willingness to undergo arthroscopic ACL reconstruction with peroneus longus autograft.
- •Active individuals participating in sports or regular physical activity. Willingness to provide informed consent and adhere to the study protocol, including follow-up visits and rehabilitation.
- •Ability to understand and complete study questionnaires. -
排除标准
- •Previous knee surgery on the affected limb. Concomitant ligamentous injuries requiring additional reconstruction (e.g., PCL, MCL, LCL Grade III).
- •Significant chondral damage (Outerbridge grade > 2 on pre-operative MRI or intra-operative assessment).
- •Pre-existing knee osteoarthritis (Kellgren-Lawrence grade > 2). Systemic inflammatory conditions (e.g., rheumatoid arthritis). Bleeding disorders or coagulopathies. Current use of anticoagulants. Corticosteroid injection into the knee within 6 weeks prior to surgery. Pregnancy or lactation. Inability to comply with the rehabilitation protocol. Infection or history of infection in the affected knee. History of previous contralateral ACL injury (to isolate primary injury outcomes).
研究组 & 干预措施
Intraarticular PRP Group
Intraarticular Platelet rich plasma injection
干预措施: PRP injection (Biological)
Saline group
Normal saline group
干预措施: PRP injection (Biological)
结局指标
主要结局
KOOS4 score
时间窗: 12 months
To compare knee-related functional outcomes, as measured by the KOOS4 score, between patients undergoing arthroscopic ACL reconstruction with peroneus longus autograft and intra-articular PRP injection versus those undergoing ACL reconstruction with peroneus longus autograft alone at 3-, 6-, and 12-months post-surgery.
次要结局
未报告次要终点
研究者
Hafiz Sohail Ahmad
Post Graduate Resident
Lahore General Hospital
