Comparative Study of Functional Outcomes Between Peroneus Longus and Hamstring Tendon Autografts in Arthroscopic ACL Reconstruction: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Knee instability
研究概览
简要总结
This is a prospective, single-blinded, randomized controlled trial. Sixty patients (≥18 years) with an isolated ACL injury will be randomly assigned to receive an ACL reconstruction using either a Peroneus Longus Tendon (PLT) autograft or a Hamstring Tendon (HST) autograft. The primary objective is to compare early functional outcomes between the two groups at 6 weeks and 3 months post-surgery, using the Lysholm Knee Score. The study aims to demonstrate the non-inferiority of the PLT graft. All surgeries will be performed arthroscopically at Khyber Teaching Hospital, Peshawar, followed by a standardized rehabilitation protocol.
详细描述
This study compares two autograft sources for anterior cruciate ligament (ACL) reconstruction. While the hamstring tendon (HST) is a widely used standard, it is associated with donor-site complications such as anterior knee pain and weakness. The peroneus longus tendon (PLT) has emerged as a potential alternative, offering similar biomechanical strength with the possibility of reduced donor-site morbidity. However, robust comparative data, particularly focusing on early functional recovery, remain limited, creating a need for high-quality evidence to guide surgical decision-making.
To this end, the trial is designed as a single-center, prospective, randomized controlled study. Sixty patients will be randomly assigned to receive ACL reconstruction using either a PLT or HST autograft, with functional outcomes assessed via the Lysholm Knee Score at six weeks and three months postoperatively. The methodology includes rigorous allocation concealment, blinding of the outcome assessor, and an intention-to-treat statistical analysis to robustly test the non-inferiority of the PLT graft.
The trial has received ethical approval, and all participants will provide informed consent. The findings aim to contribute meaningful evidence to clinical practice and will be disseminated through peer-reviewed publications and scientific conferences, with the goal of informing safer and more effective surgical choices for patients with ACL injuries.
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
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the surgical intervention, the participating surgeons and patients cannot be blinded to the group assignment. However, the independent assessor responsible for collecting the primary outcome (Lysholm Knee Score) will be blinded to which graft type the participant received.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years or older.
- •Isolated, primary Anterior Cruciate Ligament (ACL) injury confirmed by clinical assessment and Magnetic Resonance Imaging (MRI).
- •Provides written informed consent for the surgical procedure and study participation, including follow-up assessments.
排除标准
- •Multiligament knee injuries (e.g., concomitant PCL, MCL, or LCL injuries).
- •Previous surgery or history of fracture in the involved lower limb.
- •Radiographic evidence of osteoarthritis in the affected knee.
- •Presence of any neuromuscular disease.
研究组 & 干预措施
Peroneus Longus Tendon (PLT) Autograft Group
Participants will undergo arthroscopic anterior cruciate ligament (ACL) reconstruction using an autograft harvested from their own ipsilateral peroneus longus tendon (PLT). The tendon will be harvested through a 2-3 cm incision proximal to the lateral malleolus, with a tenodesis of the peroneus brevis performed at the donor site. The graft will be prepared and fixed using an Endobutton on the femoral side and an adjustable button system (ABS) on the tibial side via a standard single-bundle technique.
干预措施: Peroneus Longus Tendon Autograft Harvest and ACL Reconstruction (Procedure)
Hamstring Tendon (HST) Autograft Group
Participants will undergo arthroscopic anterior cruciate ligament (ACL) reconstruction using an autograft harvested from their own ipsilateral hamstring tendons (semitendinosus and gracilis). The tendons will be harvested, prepared as a quadrupled graft, and fixed using an Endobutton on the femoral side and an adjustable button system (ABS) on the tibial side via a standard single-bundle technique.
干预措施: Hamstring Tendon Autograft Harvest and ACL Reconstruction (Procedure)
结局指标
主要结局
Knee instability
时间窗: 6 weeks, 3 months after surgery
A Lysholm Knee Score validated patient-reported outcome measure assessing knee function, symptoms, and instability. Scores range from 0 to 100, with higher scores indicating better function. Outcomes are categorized as Excellent (\>90), Good (65-89), or Poor (\<64).
Knee function
时间窗: 6 weeks, 3 months after surgery
A Lysholm Knee Score validated patient-reported outcome measure assessing knee function, symptoms, and instability. Scores range from 0 to 100, with higher scores indicating better function. Outcomes are categorized as Excellent (\>90), Good (65-89), or Poor (\<64).
次要结局
未报告次要终点