Single-blind, Multi-centre, Randomized Controlled Trial Comparing Ligamys Anterior Cruciate Ligament (ACL) Repair, Internal Bracing ACL Repair and Conventional ACL Reconstruction for Relative Clinical Efficacy and Economic Benefit.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 95
- 试验地点
- 6
- 主要终点
- International Knee Documentation Committee (IKDC) Score
研究概览
简要总结
Single-blind, multi-centre, prospective, randomized controlled trial comparing Ligamys Anterior Cruciate Ligament (ACL) repair, Internal Bracing ACL repair and conventional ACL reconstruction for relative clinical efficacy and economic benefit.
Patients with a primary proximal acute ACL rupture will be included in either study 1 (0-4 weeks post rupture) or study 2 (5-12 weeks post rupture) of the LIBRE study.
详细描述
Rationale The conventional operative treatment of an anterior cruciate ligament (ACL) rupture is an ACL reconstruction, whereby the residual ruptured ACL is removed and replaced by an autograft hamstring tendon.
Recently, two alternative natural healing techniques have been developed and proof of concept have been established. The two repair techniques are: Dynamic Intraligamentary Stabilization (DIS) and Internal Brace Ligament Augmentation (IBLA). Both DIS and IBLA allow the rupture to heal by itself. The biggest difference between the two techniques is that the DIS system consists of a polyethylene suture and a spring screw system, which stabilizes the knee joint with the same force during flexion and extension of the knee, and the IBLA system consists of a 2mm high molecular weight polyethylene FiberTape®.
Objective The aim is to identify the optimal ACL technique for treating an acute ACL injury that can deliver an enhanced clinical efficacy and economic benefit for two time frames (0-4 weeks and 5-12 weeks) following ACL rupture.
Study design Two separate, interventional, single-blind, comparative, multi-centre, randomized controlled trials (RCTs) will be conducted. The University Hospital of Antwerp (UHA), University Hospital of Brussels (UHB) and OLV Hospital (OLVH) are the three participating sites. A total of 96 patients will be included in the study, 48 for study 1 and 48 for study 2.
The anticipated study duration is 72 months which will include a five month starting-up phase, 40 month recruitment period, a 24 month follow-up period and three months for final analysis. The study data will be collected over three periods: pre-operative, per-operative and post-operative.
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)
盲法说明
Also the treating physiotherapist is blinded to the treatment the participant received.
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
- •• Primary acute proximal ACL rupture (MRI and per-operative confirmation): 3-digit ACL rupture classification, type A (supplement 1)
- •Between 18-50 years, male or female
- •Randomization and surgery within 4 weeks after the ACL rupture (Study 1)
- •Randomization and surgery between 5-12 weeks after the ACL rupture (Study 2)
- •The ACL remnant is suitable for repair in the three treatment groups: the distal ACL remnant must be in contact with the proximal remnant/femoral condyle for at least 75% (per-operative confirmation)
- •The patient is mentally and verbally capable of participating in the study.
- •Written informed consent (according to the International Conference on Harmonisation (ICH)-GCP Guidelines).
排除标准
- •• Known posterior cruciate ligament (PCL) and/or posterolateral ligamentous complex (PLC), lateral collateral ligament (LCL) or medial collateral ligament (MCL) grade 3 injury.
- •Known osseous fractures that could impair revalidation and/or ACL repair
- •Patients with neurological disorders or systemic diseases
- •Patients with trauma/fractures in the lower limb in the past 6 months that could influence rehabilitation
- •Non-sportive patients with a Tegner score of <3: these patients could probably counteract instability complaints with intensive physiotherapy.
- •Any inflammatory disease, Rheumatoid Arthritis (RA), Spondyloarthropathy (SpA), active malignancy
- •Patient not suited for intervention due to lack of mobility, meaning not achieving 90° of flexion before surgery.
结局指标
主要结局
International Knee Documentation Committee (IKDC) Score
时间窗: Baseline (pre-rupture), week 13, week 26, week 52, week 104. At 6 months follow-up the primary outcome will be measured, a change of 13 IKDC points between the treatments is considered clinically meaningful.
The International Knee Documentation Committee (IKDC) is a commonly used instrument to determine the outcome following various knee procedures, including ACL reconstructions. In essence, it is a subjective well-known tool that provides patients with an overall function score (range between 0 to 100). The score is interpreted as a measure of function with higher scores representing higher levels of function. The questionnaire addresses 3 categories: symptoms (i.e. pain, swelling, stiffness etc.), activity (rising from chair, going up and down stairs, jumping, squatting etc.) and knee function. The knee function studies focus primarily on one question: "How is the knee function post-operative compared to the situation before the injury?". In conclusion, the IKDC score is a reliable, well established and both patient and clinician friendly tool (i.e. it is easy and it requires little time to complete).
次要结局
- Tegner score(Baseline (pre-rupture), week 13, week 26, week 52, week 104.)
- EQ-5D-5L(Baseline (pre-operative), day 1, week 2, week 6, week 13, week 26, week 52, week 104.)
- Failure (re-rupture/instability complaints)(Day 1, week 2, week 6, week 13, week 26, week 52, week 104.)
- Lysholm score(Baseline (pre-rupture), week 13 post-operative, week 26 post-operative, week 52 post-operative, week 104 post-operative)
- Return to work/sport(Day 1, week 2, week 6, week 13, week 26, week 52, week 104.)
- Isokinetic measurement (Biodex/CSMI)(Pre-operative, week 13, week 26, week 52.)
- MRI(Pre-operative, week 26, week 52, week 104.)
- Visual Analogue Scale (VAS) Pain(Baseline (pre-operative), day 1, week 2, week 6, week 13, week 26, week 52, week 104.)
- Visual Analogue Scale (VAS) Satisfaction(Week 6, week 13, week 26, week 52, week 104.)
研究者
Christiaan Heusdens
Dr.
University Hospital, Antwerp