SEQUAR - SEmitendinosus vs QUadriceps in Anterior Cruciate Ligament Reconstruction - a Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- KT-1000 Knee Laxity at 6 months
研究概览
简要总结
Randomized control trial comparing two different Anterior Cruciate Ligament (ACL) grafts in Anterior Cruciate Ligament Reconstruction: the semitendinosus hamstrings graft and the quadriceps graft. Capio Artro Clinic (Stockholm) has vast experience in ACL surgery using both semitendinosus and quadriceps grafts.
详细描述
The purpose of the study is to evaluate the quadriceps graft with bone-plug in Anterior Cruciate Ligament Reconstruction (ACL-R) and compare it with the most common choice of graft, semitendinosus hamstrings graft in ACL-R in athletes with Tegner Activity Scale 7 or higher. Both methods are well-known and continually registered in the Swedish ACL Registry.
Both grafts will be compared post operatively as to knee laxity (primary outcome), PROMs, as well as measure graft site morbidity, Return to Sports rate, and the post-operative rehab. At 9 months we will also preform a MRI scan to determine graft maturity. 5-year and 10-year data will also be acquired through the Swedish ACL-registry and Lysholm score and Tegner Activity Level score. At 10-year a plain weight baring X-ray will be preformed to evaluate development of osteoarthritis.
The study design is a prospective randomized study with equal groups:
Semitendinosus graft (=100) and Quadriceps tendon graft (n=100). According to historical material from Capio Artro Clinic (Stockholm) the following power calculation has been made: Significance lever 5 percent (p=0.05) and power is 80%. The difference between the groups is 1 mm knee laxity with KT-1000 which would give an effect size of 0,44 or less compared to an average effect size (0,50). 85 individuals will be needed in each group in the statistical analysis. Although no stratification for sex will be performed, our aim is to have a balanced representation of sex that reflects the typical patient population for this condition at the clinic, with a distribution of 40% females and 60% males across both groups. Inclusion will continue until we have at least 100 individuals in each group. This means that each group can have more than 100 individuals. Randomization process and study design will be done according to the CONSORT guidelines.
Initially, the study was designed to have two primary outcome measures: KT-1000 knee laxity at 6 months and KOOS at 24 months. However, the study is only powered for the first outcome (Knee Laxity measured with KT-1000), therefore KOOS will be followed as a secondary outcome measure.
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
- None
入排标准
- 年龄范围
- 16 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pre-injury Tegner Activity Scale≥7
- •Intended return to sports to prior sport and Tegner Activity Scale Level
- •Time between injury and inclusion not more than 6 months
- •MR verified ACL rupture
排除标准
- •Previous knee injury with symptoms before ACL injury
- •Neurological disease, inflammatory disease, connective tissue disease or balance disorder
- •Previous lower limb fracture or surgery
- •Laxity in the medial collateral ligament (MCL) and lateral collateral ligament (LCL) > grade 1
- •PCL rupture or Multiligament knee injury (MLKI)
- •Radiographic sign of osteoarthritis (OA)
- •Previous knee surgery or ligament injury in contralateral knee
- •Beighton score ≥ 5
结局指标
主要结局
KT-1000 Knee Laxity at 6 months
时间窗: Pre-operative appointment and 6 months post-operative appointments
The KT-1000 measures laxity objective- and parametrically and is a validated tool for establishing joint laxity post operatively in mm.
KT-1000 Knee Laxity at 6 months
时间窗: Pre-operative appointment and 6 months post-operative appointments
The KT-1000 measures laxity objective- and parametrically and is a validated tool for establishing joint laxity post operatively in mm.
次要结局
- ACL-RSI(6 months and 12 months, post-operative appointments)
- Return to Sports Questionnaire(6 months, 9 months and 12 months, 18 months, and 24 months post-operative appointments)
- Werner anterior knee pain score(6 weeks, 6 months, 9 months, and 12 months)
- Kartus anterior knee pain score(6 weeks, 6 months, 9 months, and 12 months)
- Graft site morbidity questionnaire(6 weeks, 6 months, 12 months, 24 months)
- Goniometric measurement: Knee extension and flexion(2 weeks, 6 weeks, 6 months, 9 months and 12 months)
- Measurement of circumference of the knee(2 weeks, 6 weeks, 6 months, 9 months and 12 months)
- Biodex Isokinetic Measurement(6 months, 9 months and 12 months)
- Functional knee tests(6 months, 9 months and 12 months)
- Lachmans test(Pre-operative appointment , 6 months, 9 months and 12 months)
- Pivot shift test(Pre-operative appointment , 6 months, 9 months and 12 months)
- Time to Return to Sports Rates(6 months, 9 months, 12 months, 18 months, 24 months)
- Graft failure rate or ACL re-rupture(10 years)
- ACL re-operation(10 years)
- Graft maturity(9 months)
- 10 year X-Ray(10 years)
- KOOS(Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments)
- IKDC(Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments)
- PAS(Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments)
- EQ5D(Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments)
- Tegner Activity Score(Pre-operative appointment, 6 months, 9 months, 12 months, 18 months, 24 months, 5 years and 10 years post-operative appointments)
- KOOS(Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments)
- IKDC(Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments)
- PAS(Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments)
- Tegner Activity Score(Pre-operative appointment, 6 months, 9 months, 12 months, 18 months, 24 months, 5 years and 10 years post-operative appointments)
- EQ5D(Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments)
- ACL-RSI(6 months and 12 months, post-operative appointments)
- Return to Sports Questionnaire(6 months, 9 months and 12 months, 18 months, and 24 months post-operative appointments)
- Werner anterior knee pain score(6 weeks, 6 months, 9 months, and 12 months)
- Kartus anterior knee pain score(6 weeks, 6 months, 9 months, and 12 months)
- Graft site morbidity questionnaire(6 weeks, 6 months, 12 months, 24 months)
- Goniometric measurement: Knee extension and flexion(2 weeks, 6 weeks, 6 months, 9 months and 12 months)
- Measurement of circumference of the knee(2 weeks, 6 weeks, 6 months, 9 months and 12 months)
- Biodex Isokinetic Measurement(6 months, 9 months and 12 months)
- Functional knee tests(6 months, 9 months and 12 months)
- Lachmans test(Pre-operative appointment , 6 months, 9 months and 12 months)
- Pivot shift test(Pre-operative appointment , 6 months, 9 months and 12 months)
- Time to Return to Sports Rates(6 months, 9 months, 12 months, 18 months, 24 months)
- Graft failure rate or ACL re-rupture(10 years)
- ACL re-operation(10 years)
- Graft maturity(9 months)
- 10 year X-Ray(10 years)
研究者
Anders Stalman
Senior Consultant, Principal Investigator, Ph.D.
Karolinska Institutet