Comparison of Single-bundle Versus Double-bundle Anterior Cruciate Ligament Reconstruction: Short-term and Long-term Function and Imaging Results
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- TEGNER SCORE
研究概览
简要总结
The goal of this retrospective randomized study is to compare two surgical techniques (single vs. double bundle) of ACL (anterior cruciate ligament) reconstructions in participants with rupture of anterior cruciate ligament without major other injuries of the injured knee (exclusion criteria defined).
The main question it aims to answer are:
- which surgery gives better outcome in patients (short- and long-term results)?
- are there any sings of osteoarthritis in an injured knee compared to a healthy knee?
Participants will be invited to our clinic after 15 years to do clinical and functional exams with x-Ray and magnetic resonance imaging (MRI) of both knees. Subjective exams with different scores (Tegner score, Lysholm score..) were also done. The same exam protocol for participant was used again after two years and fifteen years since surgery.
详细描述
Double bundle (DB) ACL reconstruction has gained popularity in the last few years. Biomechanical and intra - operative studies have shown better antero - posterior and rotational stability after DB vs. single bundle (SB) reconstruction. However, only few studies are found in the literature that have evaluated and compared clinical results between SB and DB ACL reconstruction. All reported studies used hamstrings in both DB and SB techniques. No studies were found that used patellar tendon autograft for the SB.
The purpose of the present study was therefore to evaluate and compare the clinical results of DB hamstring and SB patellar tendon ACL reconstruction techniques.
A total of 40 patients (29 male and 11 female, average (SD) age 36) were randomized during routine surgery (2 years after the surgery) into either double bundle (DB) or single bundle (SB) group. Patients with combined (medial, lateral or posterior) ligamentous injuries were not included in the study. ACL reconstruction in DB group was done by four tunnel hamstring technique with EndoButton femoral and cancellous screw tibial fixation. In the SB group patellar tendon autograft was fixed with titanium interference screws. The same postoperative rehabilitation protocols were used for both groups.
Subjective evaluation comprised IKDC (International Knee Documentation Committee) subjective score, Tegner activity and Lysholm scores. Objective evaluation was done by the IKDC 2000 knee examination protocol. Antero - posterior stability was measured by KT 2000 (knee arthrometer) and by Rollimeter. One leg hop test was performed to assess the functional results. Isokinetic thigh muscle strength measurements on Biodex isokinetic dynamometer were performed.
The same protocol was performed for the clinical exams after 15 years since surgery. A total of 30 patients were examen. Investigators also did imaging of both knees (X-ray and MRI) for checking the sings of osteoarthritis.
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 (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •complete ACL rupture
- •symptoms and clinical sings for rupture of ACL (instability of knee, swelling, pain, reduced knee function,...)
- •patient consent
- •magnetic resonance with this of kind injury
排除标准
- •associated injuries to other knee ligaments
- •major meniscus injuries
- •X-ray abnormalities of injured knee
- •preliminary ACL reconstruction
- •associated injury to the other knee
研究组 & 干预措施
Single bundle ACL reconstruction
In this group we chose to do surgery of ACL reconstruction with single bundle (patellar ligament).
干预措施: ACL reconstruction single bundle (Procedure)
Double bundle ACL reconstruction
In this group we chose to do surgery of ACL reconstruction with double bundle - hamstring ligament.
干预措施: ACL reconstruction double bundle (Procedure)
结局指标
主要结局
TEGNER SCORE
时间窗: 2 years and 15 years after surgery
Daily activities, limitations
LYSHOLM SCORE
时间窗: 2 years and 15 years after surgery
Daily activities, limitations
IKDC SUBJECTIVE SCORE
时间窗: before surgery, 2 years and 15 years after surgery
Daily activities, limitations
OBJECTIVE PARAMETER: AP TRANSLATION (anterior-posterior)
时间窗: 2 years and 15 years after surgery
Measured by KT 1000 and Rollimeter. Laxity was expressed as the difference between injured knee and uninjured knee in millimeters.
OBJECTIVE PARAMETER: STREENGHT OF FLEXORS AND EXTENSORS
时间窗: 2 years and 15 years after surgery
Measurements with Biodex isokinetic Dynamometer (deficit (%) at 60 deg/s and 180 deg/s; operated to nonoperated ratio (total work))
次要结局
未报告次要终点