JUPITER 4.0 - Risk Factors for Failure of Isolated Medial Patellofemoral Ligament Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 850
- 试验地点
- 16
- 主要终点
- Recurrent patellar instability
研究概览
简要总结
The goal of this observational study is to learn about the outcomes of medial patellofemoral ligament (MPFL) reconstruction for the treatment of recurrent patellar instability. The main questions it aims to answer are:
- What are the risk factors for recurrent patellar instability after MPFL reconstruction?
- What functional outcomes do patients report after MPFL reconstruction?
Participants undergoing MPFL reconstruction will answer survey questions about their knee and activity level 1 year and 2 years after surgery.
详细描述
The JUPITER group consists of high-volume patellofemoral surgeons across the United States, and was organized to facilitate the collection of clinical and radiographic outcomes following surgical and non-surgical treatment of patellar instability. With this study (JUPITER 4.0), the group aims to prospectively enroll a new cohort of consecutive patients with recurrent patellar instability that would undergo isolated MPFL reconstruction regardless of radiographic measurements or anatomic risk factors to address two specific aims - 1) what patient, injury, and surgical factors lead to recurrent instability following isolated MPFL reconstruction and 2) the creation of an instability severity index score, with the long-term objective of identifying preoperatively, patients with a high risk of failure of an isolated MPFL reconstruction who may be better served with concomitant bony procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •10-35 years old
- •Recurrent patellar instability with at least one episode defined as either (1) a dislocated patella requiring reduction in the emergency department or (2) a convincing history for dislocation, associated with full giving way, and the following physical findings: (a) hemarthrosis or effusion, (b) tenderness along the medial retinaculum, and (c) apprehension when laterally directed force was applied to the patella or (3) MRI-documented dislocation with associated bone bruises
排除标准
- •Previous ipsilateral knee surgery
- •Obligatory/fixed/habitual patella dislocation or subluxation
- •Unloadable inferior or lateral chondral damage on the patella that would require a tibial tubercle transfer for unloading purposes
- •Pathologic tibiofemoral instability
研究组 & 干预措施
Isolated MPFL Reconstruction
Patients with recurrent patellar instability (2 or more dislocation and/or subluxation events) undergoing isolated MPFL reconstruction
干预措施: Medial Patellofemoral Ligament (MPFL) Reconstruction (Procedure)
结局指标
主要结局
Recurrent patellar instability
时间窗: Within 24 months post-operatively
Patient-reported patellar dislocation or subluxation
次要结局
- Patient-Reported Outcome Measures (PROMs): Kujala score(12 months post-operatively and 24 months post-operatively)
- Patient-Reported Outcome Measures (PROMs): Pedi-IKDC(12 months post-operatively and 24 months post-operatively)
- Patient-Reported Outcome Measures (PROMs): HSS Pedi-FABS(12 months post-operatively and 24 months post-operatively)
- Patient-Reported Outcome Measures (PROMs): KOOS-12(Time Frame: 12 months post-operatively and 24 months post-operatively)
- Patient-Reported Outcome Measures (PROMs): BPII 2.0(12 months post-operatively and 24 months post-operatively)
- Patient-Reported Outcome Measures (PROMs): PROMIS-29(12 months post-operatively and 24 months post-operatively)