Conservative Versus Operative Management of First Time Shoulder Dislocations
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change in PROMIS Depression CAT at 2 weeks
研究概览
简要总结
There is no consensus regarding whether rehabilitation or surgical stabilization leads to optimized outcomes for treatment of primary anterior shoulder dislocations. This prospective, randomized controlled trial therefore aims to compare arthroscopic Bankart repair versus physical therapy for the treatment of primary anterior shoulder dislocations.
详细描述
While primary anterior shoulder dislocations had been previously treated conservatively, growing concerns amidst recurrent shoulder instability have fueled interest in managing these injuries with surgery to mitigate the risk of future instability events. While the significant literature investigating the rates of shoulder instability with initial operative management suggests improvement outcomes, there is limited level 1 evidence to support these implications. A randomized-controlled trial (RCT) of 21 primary anterior shoulder dislocations undergoing arthroscopic Bankart repair or rehabilitation ( 9 operative vs 12 nonoperative; mean age: 22), found lower rates of recurrent shoulder instability (11% in operative vs 72% in non-operative; p=0.004) and higher Single Assessment Numeric Evaluation (SANE) scores (88 in operative vs 57 in non-operative; p<0.002) after 36 months of follow-up. Similarly, another RCT of 76 patients (37 operative vs 39 non-operative; mean age: 22), found lower rates of recurrent shoulder instability (2.7% in operative vs 53.8% in non-operative; p<0.01) and higher Oxford assessment scores (70% with either 'excellent' or 'good' scores in operative group vs 26% with either 'excellent' or 'good' scores in non-operative group) after 10 years of follow-up. A RCT of 31 patients (16 operative vs 15 non-operative; mean age: 22), found lower rates of recurrent instability ( 19% in operative vs 60% in non-operative; p=0.02) but no significantly different Western Ontario Score Indices (WOSI) (86% in operative vs 75% in non-operative; p=0.17) at a follow up of 79 months. A RCT of 91 patients (44 operative vs 47 non-operative; mean age: 22), found lower rates of recurrent instability (2.3% in operative vs 19.1% in non-operative; p=0.01) and no significantly difference in WOSI (92.7% in operative vs 91.5% in non-operative; p>0.05) at 2 years follow-up. A RCT of 40 patients (20 operative vs 20 non-operative; mean age: 21), found lower rates of recurrent shoulder instability (10% in operative vs 70% in non-operative; p=0.0001) and a higher WOSI (17.1 in operative vs 11.5 in non-operative; p=0.035) at 2 years follow-up. The previous 5 RCT's represent the only level 1 evidence amidst a much larger proportion of lower-level evidence upon which much of the discussion of surgical vs non-operative management has been formulated. Additionally, only 2 RCT's conducted power analyses to determine if their sample size was adequate, and they did not demonstrate unanimous results with patient reported outcomes as described above. It is therefore critical to increase the amount of level 1 evidence on the topic of operative vs non-operative management of primary shoulder dislocations to better inform this debate. This study aims to compare the incidence of recurrent shoulder instability and patient reported outcomes of patients with primary anterior shoulder dislocations managed with surgery (arthroscopic Bankart repair) compared to non-operative management (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
- •patients 12 and older
- •seen by the Columbia University Shoulder Elbow and Sports Medicine Service
- •first time anterior shoulder dislocation diagnosis
排除标准
- •humeral avulsion during arthroscopy
- •bony defect > 25% of glenoid surface
- •general anesthesia contraindication
- •previous shoulder surgery
- •inability or unwillingness to adhere to study participate
- •lost to follow up
结局指标
主要结局
Change in PROMIS Depression CAT at 2 weeks
时间窗: Baseline and 2 weeks
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS PI CAT at at 6 weeks
时间窗: Baseline and 6 weeks
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS Depression CAT at 3 months
时间窗: Baseline and 3 months
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in Western-Ontario Shoulder instability Index Score at 1 year
时间窗: Baseline and 1 year
A questionnaire ranging from 0 to 2100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS PF CAT at 1 year
时间窗: Baseline and 1 year
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in Western-Ontario Shoulder instability Index Score at 2 weeks
时间窗: Baseline and 2 weeks
A questionnaire ranging from 0 to 2100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in Western-Ontario Shoulder instability Index Score at 6 weeks
时间窗: Baseline and 6 weeks
A questionnaire ranging from 0 to 2100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS Depression CAT at 6 weeks
时间窗: Baseline and 6 weeks
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS PI CAT at 1 year
时间窗: Baseline and 1 year
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS PF CAT at 6 weeks
时间窗: Baseline and 6 weeks
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in Patient Reported Outcome Measure Information System (PROMIS) Physical function (PF) Computer Adaptive Test (CAT) at 2 weeks
时间窗: Baseline and 2 weeks
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS Pain Interference (PI) CAT at 2 weeks
时间窗: Baseline and 2 weeks
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS PI CAT at 2 years
时间窗: Baseline and 2 years
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in Western-Ontario Shoulder instability Index Score at 3 months
时间窗: Baseline and 3 months
A questionnaire ranging from 0 to 2100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in Western-Ontario Shoulder instability Index Score at 6 months
时间窗: Baseline and 6 months
A questionnaire ranging from 0 to 2100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS Depression CAT at 6 months
时间窗: Baseline and 6 months
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS Depression CAT at 1 year
时间窗: Baseline and 1 year
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS PF CAT at 2 years
时间窗: Baseline and 2 years
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in Western-Ontario Shoulder instability Index Score at 5 years
时间窗: Baseline and 5 years
A questionnaire ranging from 0 to 2100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS PF CAT at 3 months
时间窗: Baseline and 3 months
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS PI CAT at 3 months
时间窗: Baseline and 3 months
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS PF CAT at 6 months
时间窗: Baseline and 6 months
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS PI CAT at 6 months
时间窗: Baseline and 6 months
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in Western-Ontario Shoulder instability Index Score at 2 years
时间窗: Baseline and 2 years
A questionnaire ranging from 0 to 2100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS PF CAT at 5 years
时间窗: Baseline and 5 years
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS PI CAT at 5 years
时间窗: Baseline and 5 years
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS Depression CAT at 5 years
时间窗: Baseline and 5 years
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in Western-Ontario Shoulder instability Index Score at 10 years
时间窗: Baseline and 10 years
A questionnaire ranging from 0 to 2100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS PF CAT at 10 years
时间窗: Baseline and 10 years
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS Depression CAT at 10 years
时间窗: Baseline and 10 years
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Percentage of Participants with Recurrent Instability
时间窗: 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years
Percentage of participants in each group that experience shoulder dislocation after treatment initiates will be measured at each timepoint.
Change in PROMIS Depression CAT at 2 years
时间窗: Baseline and 2 years
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Change in PROMIS PI CAT at 10 years
时间窗: Baseline and 10 years
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their shoulder injury. A lower score indicates a better outcome.
次要结局
- Change in Constant-Murley Score at 6 months(Baseline and 6 months)
- Change in Subjective Shoulder Value Score at 2 weeks(Baseline and 2 weeks)
- Change in Rowe Score at 2 weeks(Baseline and 2 weeks)
- Change in Constant-Murley Score at 2 weeks(Baseline and 2 weeks)
- Change in Subjective Shoulder Value Score at 6 months(Baseline and 6 months)
- Change in Subjective Shoulder Value Score at 1 year(Baseline and 1 year)
- Change in Subjective Shoulder Value Score at 5 years(Baseline and 5 years)
- Change in Rowe Score at 6 weeks(Baseline and 6 weeks)
- Change in Rowe Score at 3 months(Baseline and 3 months)
- Change in Rowe Score at 5 years(Baseline and 5 years)
- Change in Rowe Score at 10 years(Baseline and 10 years)
- Change in Subjective Shoulder Value Score at 6 weeks(Baseline and 6 weeks)
- Change in Subjective Shoulder Value Score at 3 months(Baseline and 3 months)
- Change in Constant-Murley Score at 6 weeks(Baseline and 6 weeks)
- Change in Constant-Murley Score at 2 years(Baseline and 2 years)
- Change in Constant-Murley Score at 5 years(Baseline and 5 years)
- Change in Subjective Shoulder Value Score at 2 years(Baseline and 2 years)
- Change in Subjective Shoulder Value Score at 10 years(Baseline and 10 years)
- Change in Rowe Score at 6 months(Baseline and 6 months)
- Time to baseline functional status(Measured once per patient, depending on the time required to return to full activity (up to 10 years)
- Change in Constant-Murley Score at 3 months(Baseline and 3 months)
- Change in Constant-Murley Score at 1 year(Baseline and 1 year)
- Change in Constant-Murley Score at 10 years(Baseline and 10 years)
- Change in Rowe Score at 1 year(Baseline and 1 year)
- Change in Rowe Score at 2 years(Baseline and 2 years)