跳至主要内容
临床试验/NCT02185001
NCT02185001终止不适用

Repair of Medial Patellofemoral Ligament Compared to Conservative Treatment for First Time Patella Dislocation; A Randomized Prospective Trial

Orthopedic Specialty Institute2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2014年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
2
试验地点
2
主要终点
Patient Reported Change in Patellar Stability, Subluxation, or Recurrent Dislocation.

研究概览

简要总结

Background: The forces involved in a patella dislocation event can cause significant collateral damage involving the articular cartilage of the patella femoral joint. As a result, prevention of recurrent patella dislocation and the associated disability and morbidity has generated significant interest in the orthopedic community. Historically, nonoperative treatment for first time patella dislocation has been problematic due to high redislocation rates. Nonoperative protocols generally involve bracing and/or immobilization, followed by physical therapy (1). Surgical approaches to recurrent patella dislocation, both soft tissue and boney realignment operations, have also had mixed results, including low success rates, associated complications, and variable rates of return to functional activity (2,3,4). This study is intended to compare the outcomes of a relatively low-risk Medial Patellofemoral Ligament (MPFL) direct repair procedure to conservative treatment.

Methods/Design: This study is designed as a two arm randomized prospective trial. Approximately fifty subjects will be randomly assigned to either a surgical or non-operative arm by means of a computer randomized allocation program. All subjects will have X-Ray Images and Magnetic Resonance Imaging (MRI) to determine the site of the MPFL damage, and to determine if any excluding conditions exist. Subjects randomized to the surgical group will have repair of the MPFL. Routine aftercare will consist of physical therapy in a clinic that has agreed to follow our protocol. Subjects randomized to the nonoperative group will receive 2 weeks of patellar immobilization, followed by patellar stabilization bracing with physical therapy for approximately 12 weeks. Physical therapy will progress through five phases with the goal of gait normalization, full range of motion and return to sport. Both arms will be given outcome questionnaires and physical activity assessments before treatment, and at one, three, six, twelve, and twenty four month intervals.

Discussion: This prospective randomized trial will investigate the results of direct repair of the medial patellofemoral ligament and conservative treatment by applying subjective outcome measures (Kujala scores), and exam findings to determine MPFL functional restoration or redislocation. Subjects will be examined in the clinic setting at 10 days, one month, and six months post trauma. Any reported recurrent dislocation or subluxation event will be documented during recovery. All subjects will receive merchant x-ray views at 3 months with manual lateral translation of the patella.

详细描述

Background Historic treatment for first time patella dislocation has been largely conservative. Treatment options include nonoperative treatment and a large variety of operative options. Nonoperative treatment, usually consists of bracing and/or immobilization followed by physical therapy, has been problematic due to a relatively high reported redislocation rate(1). The forces involved in a patella dislocation event can damage the articular cartilage of the patella femoral joint. As a result, prevention of recurrent patella dislocation and the associated disability and morbidity has generated significant interest in the orthopedic community.

Historic surgical approaches to recurrent patella dislocation have had mixed results. The isolated "lateral release", has been shown to have a very low success rate(2), while associated complications have been appreciated. Lateral release procedures are now more often performed in conjunction with other proximal or distal realignment procedures(3). More aggressive bone realignment procedures such as tibial tubercle transfers have the disadvantage of reported poor long term functional recoveries and low "return to sport" rates(4,5).

There has been increasing interest in ligament reconstruction for patella dislocation. The ligament of interest is the medial patella-femoral ligament (MPFL), which is essentially a thickened band of the medial capsule of the knee. The MPFL has been established as the primary constraint to patella dislocation. This ligament extends from a point just anterior to the attachment of the medial collateral ligament to the medial aspect of the patella, and is routinely disrupted with a patella dislocation event. The goals of reconstruction procedures are to replace and/or augment this band of tissue. While many reports of the results of MPFL reconstruction have been good to excellent, there are significant associated risks of complication, prolonged recovery, and associated graft costs or autograft harvest morbidity.

An alternative approach to MPFL functional restoration, and the subject of this study proposal, is a direct repair of the MPFL. Variations of this approach have been previously studied. A basic understanding of established injury patterns to the MPFL is requisite to evaluating the limitations to these studies.

Studies evaluating MPFL injury by MRI have shown that acute patella dislocations have a very high incidence of associated MPFL injury. The location of the lesion in the ligament can be described in one of four ways: 1) at the patellar attachment, 2) at the femoral attachment, 3) intrasubstance portion of the ligament, or 4) a combined injury pattern. Several studies have demonstrated varying percent distributions of injury(6,7), but it is clear that all patterns exist. This conclusion is consistent with the author's experience is treating these injuries.

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
10 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A first patellofemoral traumatic dislocation
  • A need for reduction
  • An absence of fractures on x-ray exam of the frontal and lateral knee and axial patella
  • An absence of knee ligament lesions with surgical indications (with the exception of the MPFL)
  • No previous knee surgery

排除标准

  • A prior episode of patellofemoral dislocation
  • Fractures on x-ray exam of the frontal and lateral knee and axial patella Prior surgery on the knee
  • Tibial tuberosity-trochlear groove distance greater than 20mm
  • Current pregnancy or plan to become pregnant during the study period.

结局指标

主要结局

Patient Reported Change in Patellar Stability, Subluxation, or Recurrent Dislocation.

时间窗: 24 months, or as reported by subject

Subjects will be divided into 3 groups relating to patellar stability: 1. Recurrence, indicating that the patient had a recurrent patellofemoral dislocation (total loss of congruence between the patella and trochlea) prior to 24 months. 2. Unstable, indicating that the patient's knee presented with a positive apprehension test or showed signs of subluxation prior to 24 months, but without recurrent dislocation. 3. Stable, indicating that the patient's knee did not show positive signs of episodes of subluxation at 24 months.

次要结局

  • Subjective Outcome Measurement (Kujala Test)(1, 3, 6, 12, and 24 months)

研究者

发起方
Orthopedic Specialty Institute
申办方类型
Industry
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Repair of Medial Patellofemoral Ligament Compared to... | 临床试验