Optimizing GRAft SElection for ACL Reconstruction (GRASE-ACL Trial) - a Three-armed Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Rate of Torque Development - Limb Symmetry Index (RFD-LSI).
研究概览
简要总结
Purpose:
To investigate the differences between the three most common methods for reconstruction of the anterior cruciate ligament (ACL), to support the development of the best method for the individual patient.
Main research area: ¨ Sports Orthopedic Surgical research.
State of the art:
Every year in Denmark 2500 patients receive surgical reconstruction surgery to replace a ruptured ACL. Many patients experience a decline in knee function and 4-12% suffer a new ACL rupture within 5 years. According to data from the Danish ACL register, three methods of reconstruction are most prevalent, but with large variation between hospitals. This indicates lack of consensus on optimal surgical procedure.
Design:
Assessor-blinded randomized controlled study. 150 patients aged 18-40 with ruptured ACL are allocated to reconstruction with tendon(s) harvested from either the semitendinosus and gracilis, or the patella tendon, or the quadriceps tendon. Patient follow-up will be conducted preoperatively and 1, 6, 12, 24 months postoperatively.
Primary technologies and outcomes:
- Patient-reported knee-joint function, quality of life and donor-site morbidity is obtained with standardized questionnaires. Primary outcome is subjective knee function with the International Knee Documentation Committee evaluation form (IKDC)
- Instrumented analysis of knee-joint coordination and neuromuscular control including 3-D motion capture and electromyography (EMG) during single leg jumps, landings and change-of-direction. Measurement of maximal explosive muscle power in knee extension and flexion. Primary outcome is relative difference between injured and healthy leg in rate of force development (RFD-LSI).
- Standard clinical knee examination of range of motion and instrumented examination of knee-joint stability.
- Magnetic Resonance Imaging (MRI) of the thigh muscles for examination of muscle morphology.
The trial is designed for publication in three primary publications
- - Patient reported effect of graft choice in ACL reconstruction
- - Biomechanical effect of graft choice in ACL reconstruction
- - Clinical effect of graft choice in ACL reconstruction
Additional secondary publications are in the pipeline. Reference to primary protocol and results will always be emphasized in secondary publication to ensure methodological transparency.
详细描述
Purpose:
The aim of this randomized controlled trial is to investigate the effect of graft choice in anterior cruciate ligament (ACL) reconstruction surgery, primarily from a patient-centered as well as a novel biomechanical perspective; and secondly from a clinical and muscle morphological perspective.
The study compares the three most common methods for ACL reconstruction: autograft harvested from the m. quadriceps tendon (QT), the hamstring tendons (ST/Gr), and the patella tendon (BPTB).
By applying this 360° scientific approach, it is the hope to improve the possibilities for a much-needed evidence-based and individualized treatment of ACL ruptures.
Objectives and hypotheses:
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
Outcome assessors are blinded to group allocation. Before each patient visit, tape will be placed on possible scars to hide donor graft site. Given the nature of the intervention, blinding of patients and surgeons is not feasible.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •List of Inclusion criteria
- •clinically confirmed first-time ACL rupture
- •Current injury sustai´ned within 2 years
- •high activity level prior to ACL rupture (Tegner score ≥ 3) and personal goal of returning to physical activity.
- •List of preoperative
排除标准
- •Inadequate Danish language skills to answer questionnaires.
- •Prior ligament surgery in the injured knee
- •Prior ligament surgery in the non-injured knee
- •Instability of the non-injured knee
- •Known osteoarthritis (Kelgren Lawrence score ≥ 2)
- •Prior open surgery to either knee
- •Prior severe fracture involving knee joint surfaces
- •Prior severe injury to thigh muscles in either leg (e.g. tear or compartment)
- •Prior severe injury to the patella tendon of either knee (e.g. subluxation)
- •Medical condition preventing full participation (e.g. active cancer, - rheumatoid arthritis)
- •Psychiatric condition preventing full participation
- •Pregnancy
- •Obesity (BMI > 30)
- •List of Perioperative exclusion criteria (Arthroscopy)
- •Medial meniscus lesion > 50%
- •Lateral meniscus lesion > 50%
- •Treated Meniscal root lesion or radial meniscal tear that require restrictive regimen
- •Cartilage lesion >2cm2, Articular cartilage injury classification (ICRS) grade 3
- •Concurrent ligament injury (except medial collateral ligament (MCL) lesion grade 1-2)
研究组 & 干预措施
St/Gr-graft
Semitendinosus/gracilis autograft (n=50)
干预措施: ST/Gr graft (Procedure)
BPTB-graft
Patella tendon autograft (n=50)
干预措施: BPTB graft (Procedure)
QT-graft
Quadriceps tendon autograft (n=50)
干预措施: QT graft (Procedure)
结局指标
主要结局
Rate of Torque Development - Limb Symmetry Index (RFD-LSI).
时间窗: 12 months follow up
Hamstring and quadriceps rate of torque development in the injured/operated leg compared to the healthy leg, expressed in percentage with 100% being full symmetry and the best outcome.
International Knee Documentation Committee score (IKDC).
时间窗: 12 months follow up.
Patient-reported knee function based on a questionnaire, expressed on a scale form 0-100 with 100 being the best outcome.
次要结局
- Knee and hip moments.(Baseline, 6, and 12 months follow up.)
- Knee laxity(Baseline, 6, and 12 months.)
- Hamstring muscles retraction(At 12 months follow up.)
- Donor site discomfort.(Baseline, 6, 12, and 24 months follow up.)
- Rate of torque Development - Limb Symmetry Index (RFD-LSI).(Baseline, 1, 6, and 24 months follow up.)
- Return to sport questionnaire.(Baseline, 6, 12 and 24 months follow up.)
- Knee and hip angles.(Baseline, 6, and 12 months follow up.)
- Number of patients undergoing revision surgery due to graft failure.(Baseline, 12, and 24 months follow up.)
- Number of patients experiencing re-rupture of the operated ACL.(Baseline, 12, and 24 months follow up.)
- Workability questionnaire(Baseline, 1, 6, 12, and 24 months follow up.)
- Neuromuscular control.(Baseline, 6, and 12 months follow up.)
- Muscle cross sectional area(At 12 months follow up.)
- International Knee Documentation Committee score (IKDC).(Baseline, 1, 6, and 24 months follow up.)
- Patient Acceptable Symptom State questionnaire (PASS)(Baseline, 12, and 24 months.)
- Number of patients experiencing rupture of the contralateral ACL.(Baseline, 12, and 24 months follow up.)
研究者
Kristoffer Barfod
Consultant, MD, PhD, Associate Professor
Hvidovre University Hospital