Influence of the Different Types of Tibial Fixation in the Reconstruction of the Anterior Cruciate Ligament of the Knee: Osseous Integration, Ligament Maturation and Clinical Results.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- ACL Graft-bone integration (CT/MRI)
研究概览
简要总结
Influence of different tibial fixation methods in anterior cruciate ligament (ACL) reconstruction: bone integration, graft maturation, and clinical outcomes.
Primary Objective
To assess whether any of the four tibial fixation techniques is superior in terms of:
Graft-bone integration (CT/MRI),
Graft maturation (MRI),
Clinical outcomes (IKDC, Lysholm, Tegner scores; manual and instrumented knee stability with KT-1000 arthrometer).
Secondary Objectives
Compare clinical outcomes among groups (IKDC, Lysholm, Tegner).
Compare re-rupture rates and patient satisfaction.
Study Design
Prospective randomized trial.
The study will be registered in the international Clinical Trials registry.
Inclusion Criteria
Age ≥18 years.
Complete ACL rupture treated with arthroscopic ACL reconstruction using autologous hamstring tendons.
Exclusion Criteria
Age ≥55 years.
Patients treated with allografts, bone-patellar tendon-bone grafts, or quadriceps tendon grafts.
Malpositioned tunnels (evaluated by MRI at 6 months postop).
Previous knee surgery.
Femoral or tibial deformities.
Multiligament injuries.
Note: Soft tissue procedures (e.g., meniscal repair) are not exclusion criteria.
Randomization
Patients meeting inclusion/exclusion criteria will be randomized (via Research Randomizer: https://www.randomizer.org/
) into 3 groups:
Group A (TORN): bioabsorbable interference screw, same diameter as the tunnel.
Group B (TORN+1): bioabsorbable interference screw, one mm larger than the tunnel diameter.
Group C (TORN-BT): interference screw (same size as tunnel) + second fixation with cortical button/plate.
Sample size: 37 patients per group, 111 total.
Follow-up
Radiographic, CT, and MRI evaluation pre-op, at 15 days, and at 1 year post-op.
Clinical and radiological follow-up for 1 year.
Statistical Analysis
In the prospective phase, Student's t-test will be performed for comparison of pre- and postoperative variables. All variables will also be compared between groups and within groups (baseline vs. end of follow-up) using analysis of variance (ANOVA).
Linear regression models will be applied to test for potential significance that could be masked by confounding factors.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Complete ACL rupture treated with arthroscopic ACL reconstruction using autologous hamstring tendons.
排除标准
- •Age ≥55 years.
- •Patients treated with allografts, bone-patellar tendon-bone grafts, or quadriceps tendon grafts.
- •Malpositioned tunnels (evaluated by MRI at 6 months postop).
- •Previous knee surgery.
- •Femoral or tibial deformities.
- •Multiligament injuries.
- •Note: Soft tissue procedures (e.g., meniscal repair) are not exclusion criteria.
研究组 & 干预措施
Group A (TORN): tibial graft fixation bioabsorbable interference screw, same diameter as the tunnel.
干预措施: Anterior cruciate ligament (ACL) reconstruction (Procedure)
Group B (TORN+1): bioabsorbable interference screw, one mm larger than the tunnel diameter.
干预措施: Anterior cruciate ligament (ACL) reconstruction (Procedure)
Group C (TORN-BT): interference screw (same size as tunnel) + second fixation with cortical button
干预措施: Anterior cruciate ligament (ACL) reconstruction (Procedure)
结局指标
主要结局
ACL Graft-bone integration (CT/MRI)
时间窗: 12 months
Graft-bone integration assessed by CT or MRI according to tunnel healing and bone incorporation.
Graft maturation (MRI)
时间窗: 6-12 months
Graft maturation assessed on MRI using the Signal-to-Noise Quotient (SNQ).
次要结局
- International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score(12 months)
- Tegner Activity Scale(12 months)
- Side-to-side anterior knee laxity measured with KT-1000 arthrometer(12 months)