Prospective Randomized Controlled Trial of 3 Types of Tibial Intereference Screws for ACL Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Tibial Tunnel Widening
研究概览
简要总结
This prospective, randomized controlled trial will compare three tibial interference screw types used for graft fixation during primary anterior cruciate ligament (ACL) reconstruction: a polyetheretherketone (PEEK) screw, a biocomposite screw, and an allograft bone screw. Although interference screws are widely used for tibial fixation, the optimal screw material remains uncertain, particularly regarding its effect on tibial tunnel widening and graft incorporation.
Adult patients undergoing primary ACL reconstruction with a quadriceps tendon autograft using a standardized surgical technique will be randomly assigned to one of the three tibial fixation methods. The primary outcome is tibial tunnel widening measured by computed tomography (CT) 12 months after surgery. Secondary outcomes include graft integration assessed by magnetic resonance imaging (MRI) and patient-reported clinical outcomes, including the Lysholm, Tegner, KOOS, and ACL-Return to Sport after Injury (ACL-RSI) scores, collected during routine follow-up. The study aims to determine whether allograft bone screws reduce tunnel widening and improve graft integration compared with PEEK and biocomposite screws while maintaining comparable clinical outcomes.
详细描述
For the **ClinicalTrials.gov Detailed Description**, you generally want a more comprehensive description of the rationale, design, interventions, and objectives without reproducing the entire protocol. Here's a version suitable for direct use:
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**Detailed Description**
Anterior cruciate ligament (ACL) reconstruction is the standard surgical treatment for symptomatic ACL rupture, with interference screw fixation being the most commonly used method for tibial graft fixation. While current fixation techniques provide reliable mechanical stability, the optimal screw material remains uncertain. Commonly used polyetheretherketone (PEEK) screws are biologically inert and provide durable fixation but do not integrate with surrounding bone. Biocomposite screws are designed to gradually resorb while promoting bone ingrowth; however, their degradation characteristics have been associated with variable tunnel widening. More recently, allograft bone interference screws have been introduced as a biological alternative that may allow complete osseous incorporation while maintaining adequate initial fixation. Clinical evidence directly comparing these three fixation methods remains limited, particularly regarding their effects on tibial tunnel widening, graft incorporation, and patient outcomes.
This prospective, single-center, randomized controlled trial will compare tibial fixation using a PEEK screw, a biocomposite screw, or an allograft bone screw in patients undergoing primary ACL reconstruction. All participants will undergo reconstruction using a standardized SAMBBA technique with an ipsilateral quadriceps tendon autograft. Femoral fixation will be identical in all patients, with only the tibial interference screw differing between treatment groups. Participants will be randomized in a 1:1:1 allocation ratio using sealed envelopes. Patients, physiotherapists, and outcome assessors will remain blinded to treatment allocation throughout follow-up.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and non-pregnant female patients aged 18-70 years
- •MRI-confirmed rupture of the anterior cruciate ligament (ACL)
- •Clinically positive anterior drawer test and Lachman test
- •Subjective instability
- •Clinically and MRI-confirmed intact posterior cruciate ligament (PCL), medial collateral ligament (MCL), and posterolateral corner
- •Written informed consent obtained
- •Patient is able and willing to participate in the study
排除标准
- •Previous surgery on the affected knee joint (ACL reconstruction, fracture fixation, osteotomy, or partial joint replacement)
- •Body mass index (BMI) > 40
- •Coronal instability due to injury of the medial collateral ligament or posterolateral corner
- •Meniscal injury requiring postoperative restriction of weight-bearing (e.g., root tears, radial tears)
- •The patient is unable to speak German
- •The patient is pregnant
研究组 & 干预措施
Biocomposite Interference Screw
Biocomposite Interference Screw Fixation of the Tibial End of the Graft
干预措施: ACL Reconstruction with a Biocomposite Screw (Procedure)
PEEK Interference Screw
Polyether Ether Ketone Interference Screw Fixation of the Tibial End of the Graft
干预措施: ACL Reconstruction using a PEEK Screw (Procedure)
Shark Screw
Allograft Bone Interference Screw Fixation of the Tibial End of the Graft
干预措施: ACL Reconstruction using an Allograft Screw (Procedure)
结局指标
主要结局
Tibial Tunnel Widening
时间窗: 1 Year Postop
CT Measurement of the tibial Tunnel Widening in mm. The difference will be calculated between drilled diameter and measured diameter.
次要结局
- MRI Graft Integration(6 Months and 1 Year)
- Lysholm(1 Year postop)
- Tegner(Preop, 1 year postop)
- ACL-RSI(12 month postop)