Conservative Versus Surgical Management of First Time Patella Dislocations
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in Kujala Questionnaire Score at 2 weeks
研究概览
简要总结
There is no consensus regarding whether rehabilitation or surgical management is best for the management of a primary patellar dislocation. Consequently this prospective randomized controlled aims to compare the incidence of recurrent knee dislocations and patient reported outcomes of patients with primary patellar dislocations managed with surgery (medial patellofemoral ligament reconstruction) compared to non-operative management (a standardized rehabilitation protocol, control group).
详细描述
Long term sequalae of first-time patellar dislocations include recurrent knee instability, osteoarthritis, and a decreased quality of life, and yet there is no consensus on the best management for these patients. Despite an increasing trend toward investigating operative vs non-operative management of primary patellar dislocations, scarce level-1 evidence exists comparing the two treatment modalities. Indeed, the few meta-analyses suggesting improved outcomes of operative treatment for first time patellar dislocations mainly utilize retrospective cohort studies. A randomized-controlled trial of 39 patients with primary patellar dislocations with a mean age of 24 (21 operative vs 18 non-operative), found decreased rates of recurrent knee instability after a mean follow up of 44 months (0% in operative vs 35% in non-operative), and a higher Kujala knee score (88.9 in operative vs 70.8 in non-operative; p=0.001). A controlled but non-randomized prospective controlled trial among 69 patients with a mean age of 18, (30 operative vs 39 non-operative), found lower rates of recurrent knee instability after a mean follow up of 24 months (0% in operative vs 20.5% in non-operative and a higher Kujala knee score (86.3 in operative group vs 80.03 in non-operative; p <0.05).The scarce randomized, prospective data investigating the appropriate management in primary patellar dislocations underscores the importance of the current study in providing high-quality evidence to the debate of how to best manage primary patellar dislocations. This study aims to compare the incidence of recurrent knee dislocations and patient reported outcomes of patients with primary patellar dislocations managed with surgery (medial patellofemoral ligament reconstruction) compared to non-operative management (a standardized rehabilitation protocol, control group).
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 12 and older
- •patients seen by the Columbia University Shoulder Elbow and Sports Medicine Service
- •patients who experience a first-time patella dislocation
排除标准
- •coexistent ligament injury or osteochondral fracture necessitating acute surgical intervention
- •previous knee surgery
- •knee instability prior to injury
- •inability or unwillingness to adhere to study participate
- •lost to follow up
研究组 & 干预措施
Operative Group
This group will have surgical procedure called a medial patellofemoral reconstruction where the kneecap is anchored back into its correct position)
干预措施: medial patellofemoral reconstruction (Procedure)
Non-operative group
This group will have physical therapy for their knee dislocation by following a specific rehabilitation plan.
干预措施: Non-operative group (Procedure)
结局指标
主要结局
Change in Kujala Questionnaire Score at 2 weeks
时间窗: Baseline and 2 weeks
The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.
Change in Kujala Questionnaire Score at 5 years
时间窗: Baseline and 5 years
The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.
Change in Kujala Questionnaire Score at 10 years
时间窗: Baseline and 10 years
The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.
Change in Kujala Questionnaire Score at 2 years
时间窗: Baseline and 2 years
The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.
Time to first re-dislocation
时间窗: Up to 10 years
Time to first re-dislocation following intervention, measured in weeks
Change in Kujala Questionnaire Score at 1 year
时间窗: Baseline and 1 year
The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.
Change in Kujala Questionnaire Score at 6 weeks
时间窗: Baseline and 6 weeks
The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.
Change in Kujala Questionnaire Score at 3 months
时间窗: Baseline and 3 months
The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.
Change in Kujala Questionnaire Score at 6 months
时间窗: Baseline and 6 months
The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.
次要结局
- Time to return to full activity or sports for each group(Up to 10 years)
- Change in the Banff Patella Instability Instrument at 6 weeks(Baseline and 6 weeks)
- Change in the Banff Patella Instability Instrument at 6 months(Baseline and 6 months)
- Change in the Banff Patella Instability Instrument at 2 years(Baseline and 2 years)
- Change in the Banff Patella Instability Instrument at 5 years(Baseline and 5 years)
- Change in Norwich Patellar Instability Score at 2 weeks(Baseline and 2 weeks)
- Change in Norwich Patellar Instability Score at 1 year(Baseline and 1 year)
- Change in Norwich Patellar Instability Score at 5 years(Baseline and 5 years)
- Change in Norwich Patellar Instability Score at 10 years(Baseline and 10 years)
- Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 10 years(Baseline and 10 Years)
- Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 3 Months(Baseline and 3 Months)
- Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 6 Months(Baseline and 6 Months)
- Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 1 Year(Baseline and 1 Year)
- Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 3 months(Baseline and 3 months)
- Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 2 years(Baseline and 2 Years)
- Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 2 weeks(Baseline and 2 weeks)
- Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 2 weeks(Baseline and 2 weeks)
- Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 6 weeks(Baseline and 6 weeks)
- Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 6 months(Baseline and 6 months)
- Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 5 years(Baseline and 5 Years)
- Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 2 Years(Baseline and 2 Years)
- Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 5 years(Baseline and 5 years)
- Change in the Banff Patella Instability Instrument at 2 weeks(Baseline and 2 weeks)
- Change in the Banff Patella Instability Instrument at 3 months(Baseline and 3 months)
- Change in the Banff Patella Instability Instrument at 1 year(Baseline and 1 year)
- Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 1 year(Baseline and 1 Year)
- Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 6 weeks(Baseline and 6 weeks)
- Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 5 Years(Baseline and 5 Years)
- Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 6 weeks(Baseline and 6 weeks)
- Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 3 months(Baseline and 3 months)
- Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 2 years(Baseline and 2 years)
- Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 10 years(Baseline and 10 years)
- Percentage of participants who re-dislocate their knee after treatment at each time point within each group(2 weeks 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years)
- Change in Norwich Patellar Instability Score at 6 weeks(Baseline and 6 weeks)
- Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 10 Years(Baseline and 10 Years)
- Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 2 weeks(Baseline and 2 weeks)
- Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 1 year(Baseline and 1 year)
- Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 6 months(Baseline and 6 months)
- Change in the Banff Patella Instability Instrument at 10 years(Baseline and 10 years)
- Change in Norwich Patellar Instability Score at 3 months(Baseline and 3 months)
- Change in Norwich Patellar Instability Score at 6 months(Baseline and 6 months)
- Change in Norwich Patellar Instability Score at 2 years(Baseline and 2 years)