A Randomized Clinical Pilot Trial Comparing Isolated Medial Patellofemoral Ligament Reconstruction to Medial Patellofemoral Ligament Reconstruction Combined with Tibial Tubercle Osteotomy: SHould You TransFer the Tubercle (SHYFT)?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Study Feasibility - patient recruitment
研究概览
简要总结
The aim of this study is to investigate the role of tibial tubercle osteotomy (TTO) on the subjective and objective outcomes following medial patellofemoral ligament reconstruction (MPFL-R) in patients with an increased tibial tubercle-trochlear groove (TT-TG) distance with or without patella alta.
This Pilot RCT will assess the feasibility of conducting this study for:
- The ability to recruit study patients
- Adherence to the study protocol
- Completion rates of patient follow-up at a minimum of 12 months post-operative
详细描述
For patients with recurrent lateral patellofemoral instability, a medial patellofemoral ligament reconstruction (MPFL-R) consistently provides significant improvements in symptoms, quality of life, and return to sport. During an MPFL-R the surgeon will place a soft tissue graft from the medial patella to the femur. The graft used to create the new MPFL can be autograft (usually hamstring tendon) or allograft.
The tibial tubercle osteotomy (TTO) is a procedure designed to change the vector of the pull of the quadricep muscles by moving the insertion point of the patellar tendon. This is achieved by transferring the tendon with a block of bone to allow for consistent and reliable healing. The TTO is a versatile procedure that can move the patellar tendon insertion medially, anteriorly, or distally, or a combination of these directions. It can be used to correct a lateralized tibial tubercle or patella alta.
Despite the association of an increased TT-TG distance with patellofemoral instability, it has been difficult to demonstrate a correlation with patient outcomes after patellar stabilisation surgery. In addition, studies have been unable to correlate the pre-operative presence of patella alta with clinical outcomes after MPFL-R.
This randomized clinical pilot trial will randomly allocate patients with lateral patellofemoral instability and an elevated TT-TG distance with or without patella alta ato receive either an isolated MPFL-R or an MPFL-R in combination with a correcting TTO (medializing, distalizing, or a combination of both).
Patients will be followed for two years post-operative with subjective outcome measures and objective clinical and functional testing.
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
- 13 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 13-30 years
- •Symptomatic recurrent lateral patellofemoral instability
- •TT-TG ≥15mm measured on MRI or ≥18mm on CT scan
- •Closed physes (confirmed on knee x-rays)
排除标准
- •Caton-Deschamps ratio ≥ 1.4 on lateral radiographs
- •Femoral anteversion ≥ 25 degrees on diagnostic imaging rotational profile
- •Tibial external rotation ≥ 45 degrees on diagnostic imaging rotational profile
- •High-grade trochlear dysplasia requiring trochleoplasty
- •Significant osteoarthritis on skyline plain imaging (Kellgren Lawrence grade ≥ 2)
- •A chondral lesion of the patellofemoral joint that is undergoing a cartilage restoration procedure.
- •Unable to complete computer-based outcome questionnaires
- •Pregnant (at time of surgery)
结局指标
主要结局
Study Feasibility - patient recruitment
时间窗: 12-months post-operative
Number of study patients recruited
Study Feasibility - protocol adherence
时间窗: 12-months post-operative
Adherence to the study protocol (total number of protocol deviations)
Study Feasibility - follow-up completion
时间窗: 12-months post-operative
Number of patients completing follow-up a minimum of 12 months post-operative
次要结局
- Patellar Apprehension Test(6-, 12- & 24-months post-operative)
- Banff Patellofemoral Instability Instrument (BPII 2.0)(Baseline, and 6-,12- & 24-months post-operative)
- Functional Outcomes - Hop Testing(6-, 12- & 24-months post-operative)
- Complications(6-, 12- & 24-months post-operative)
- Post-operative Knee Pain(6-, 12- & 24-months post-operative)
- Patient satisfaction(12- & 24-months post-operative)