Comparison of Morbidity and Functional Outcomes After Anterior Cruciate Ligament Reconstruction With Bone-Tendon-Bone Graft Versus Patellar Tendon Graft Without Patellar Bone Plug in Competitive Athletes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Donor Site Morbidity
研究概览
简要总结
The purpose of this randomized study is to compare donor site morbidity and clinical and functional outcomes of both surgery techniques (bone-patellar tendon-bone (BPTB) graft versus bone-patellar tendon without patellar bone plug (PT) graft) for anterior cruciate ligament reconstruction (ACLR) in athletes. The main questions it aims to answer are:
- Does PT graft reduce donor site morbidity compared to the standard BPTB graft?
- Does PT technique provide clinical and functional results comparable to the BPTB technique? Researchers will compare the incidence of complications and clinical and functional outcomes between the BPTB and PT grafts groups.
Patients will:
- Undergo ACLR surgical intervention using one of the two assigned techniques (BPTB or PT)
- Follow a two-year assessment program, including visits at three, eight, 12 and 24 months after surgery.
详细描述
Anterior cruciate ligament (ACL) rupture is the most prevalent type of knee ligament injury, representing approximately 50% of all reported knee injuries. This injury has a particularly high impact on most athletes due to the demands of pivoting, jumping and cutting movements required during play. In addition, its consequences include a prolonged recovery period, the risk of reinjury and complications arising from ACL insufficiency, such as knee instability, meniscal tears or osteoarthritis. Given that the primary indicator of successful treatment is the athlete's ability to return to competitive levels, surgical reconstruction of the ACL (ACLR) has become the standard treatment. However, the choice of the optimal graft for ACLR remains controversial. For many authors, bone-patellar tendon-bone (BPTB) graft is considered gold-standard option due to optimal biomechanical properties and low reinjury rate. However, BPTB is usually associated with donor site morbidity, specifically related to kneeling, dysesthesia and anterior knee pain.
Given the disadvantages of the BPTB graft, an ACLR based on a bone-patellar tendon graft may be a viable alternative. This technique utilizes an autograft composed of the central third of the patellar tendon and a tibial tubercle bone plug without inclusion of the patellar bone plug, called bone-patellar tendon (BPT). Previous studies have demonstrated lower rates of anterior knee pain in BPT compared to BPTB. However, there is a lack of evidence regarding objective and specific donor site morbidity assessment for both techniques.
The main hipothesis of this study is that BPT has similar clinical an functional recovery compared to BPTB with lower rates of anterior knee morbidity.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Time for injury to surgery of less than six months.
- •Active athletes (federated or recreational)
- •Patellar tendon length > 42mm measured by MRI.
- •Age between 12 and 40 years old
- •Genders eligible for Study: both
排除标准
- •Previous surgery or history of ligamentous knee injuries.
- •Concomitant knee ligament injury
- •Major meniscal injury (more than 50% of the lateral or medial meniscus)
- •Chondral injury greater than Outerbridge Grade I-II
研究组 & 干预措施
Patellar tendon - Bone (PT)
干预措施: Patellar tendon-Bone (Procedure)
Bone - Patellar tendon - Bone (BPTB)
干预措施: Bone-Patellar tendon-Bone (Procedure)
结局指标
主要结局
Donor Site Morbidity
时间窗: At 3, 8, 12 and 24 months after surgery
Anterior Cruciate Ligament Donor-site Morbidity Questionnaire will be used to evaluate complications at the harvest site. Scores range from 0 to 100 points, where higher scores indicates better ouctome (absence of donor-site complications).
次要结局
- Functional Hop Test Battery(Baseline (Pre-intervention) and 8, 12 and 24 months after surgery)
- Donor-site pain pressure threshold(Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery)
- Hamstrings strength(Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery)
- Hamstring/Quadriceps ratio(Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery)
- Quadriceps thickness(Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery)
- Quadriceps strength(Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery)
- Patellar tendon morphology(Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery)
- Anteroposterior knee stability(Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery)
- Knee stability(Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery)
- Height(Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery)
- Weight(Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery)
- Body Mass Index (BMI)(Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery)
- Percentage of Body Fat(Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery)
- Skeletal Muscle Mass(Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery)
- Function and activity level(Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery)
- Subjective knee status(Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery)
- Psychological readiness(Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery)
- Joint Awareness(Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery)
- Patient-reported symptoms(Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery)
研究者
Jose M Rodriguez-Delgado
MsC, PT
Universidad de Granada