Open Versus Arthroscopic Stabilization of Shoulder Instability With Subcritical Bone Loss: The OASIS Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 30
- 主要终点
- Western Ontario Shoulder Instability Index (WOSI)
研究概览
简要总结
This clinical trial will determine the outcome trajectories of common surgeries (arthroscopic Bankart repair with remplissage of a Hill-Sachs lesion, open Bankart, Latarjet) with post-operative rehabilitation and identification of prognostic factors among patients with acute or recurrent anterior shoulder instability with subcritical bone loss. The results of the study assist in optimizing time to return to military duty, work and sports, and patient-reported physical function for military personnel and civilians with traumatic anterior shoulder instability and 10-20% glenoid bone loss. This study will provide a critical clinical advancement of a previously unaddressed and common clinical scenario.
详细描述
The objective of this study is to determine the outcome trajectories of common surgeries (arthroscopic Bankart repair with remplissage of a Hill-Sachs lesion, open Bankart, Latarjet) with post-operative rehabilitation and identification of prognostic factors among military personnel and civilians with acute or recurrent anterior shoulder instability with subcritical bone loss.
Aim 1: The investigators will determine the acute and long term patient relevant outcomes (Western Ontario Shoulder Instability score [WOSI], time to RTD/A at pre-injury levels, and recurrent instability/re-injury) at 6 months, 1, and 2 years of arthroscopic Bankart repair with remplissage of a Hill-Sachs lesion, open Bankart, and Latarjet.
Aim 2: The investigators will determine if participation in rehabilitation that optimizes range of motion, strength, and functional performance predicts successful RTD/A, WOSI score, and recurrent instability at 6 months, 1, and 2 years.
Subject Population: Male and female military personnel and civilians between the ages of 17 and 50 with a traumatic anterior shoulder dislocation with associated 10-20% glenoid bone loss, having undergone either an 1) arthroscopic Bankart repair with remplissage of a Hill-Sachs lesion, 2) open Bankart, or a 3) Latarjet, and plans to return to physically demanding work or sports.
Study / Experimental Design: Prospective Observational Cohort Study (Aims 1 & 2).
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
- 17 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Civilians and military personnel ages 17 to 50
- •Traumatic anterior shoulder dislocation
- •Associated subcritical bone loss between 10-20% less the glenoid width quantified by standard of care CT scan, MRI, or 3D-MRI scan
- •Had shoulder instability surgery using either 1) arthroscopic Bankart repair with remplissage of Hill-Sachs lesion; 2) open Bankart; or 3) Latarjet
排除标准
- •Chronic, non-traumatic multi-directional instability based on clinical exam
- •Concurrent shoulder injury in the involved shoulder (e.g., rotator cuff tears, motor nerve pathologies, osteoarthritis of a Samilson-Prieto grade >2)
- •Have a history of shoulder surgery in the involved shoulder (prior instability surgery that included any of the following and the planned procedure would be a repeat of the index procedure: 1) arthroscopic Bankart repair with a remplissage of Hill-Sachs lesion, 2) open Bankart, or 3) Latarjet [previous isolated arthroscopic Bankart repair only would not be an exclusion criterion], rotator cuff repair, intra-articular soft tissue surgery); rotator cuff repair, intra-articular soft tissue surgery)
- •Prior rotator cuff procedure on involved shoulder (including intra-articular soft tissue surgery
- •Humeral sided bone lesions (Hill-Sachs lesion) that is sufficiently large enough to render the lesion "off-track" even after a bony augmentation procedure would be performed
- •Neuromuscular, neurological and other movement control pathologies including seizures
- •Vascular injury associated with the shoulder trauma that compromise adequate/normal healing or interferes with usual course of care
- •Traumatic brain injury or any condition that would preclude the ability to comply with post-operative guidelines
- •Cartilage lesion finding in the involved shoulder that would interfere with usual course of care
- •Known pregnancy at time of imagining and/or surgery based upon standard of care testing procedures
- •Any issue with the contralateral shoulder that would preclude participation in research procedures
- •Any condition in the opinion of the investigator/clinician that would preclude or limit full participation in study activities
- •Absence of a fixed address or no means of contact
- •Known inability to be available at all follow-up time points
- •Does not plan to return to pre-injury levels of work, sports or military duty
结局指标
主要结局
Western Ontario Shoulder Instability Index (WOSI)
时间窗: 24 months after surgery
The Western Ontario Shoulder Instability Index (WOSI) is a 21-item instability-specific patient-reported outcome measure of physical symptoms, sports, recreation, work, lifestyle and emotions. The best possible score is 0 and a worst possible score is 2100. The WOSI was found to be responsive and sensitive to detecting change over time, demonstrating its utility as a primary outcome to evaluate treatments and to monitor participants' progress over time.
Time to Return to Pre-Injury Level of Activity
时间窗: Monthly starting at 3 months after surgery and continuing to 24 months
Time to return to pre-injury level military duty, work and sports.
Recurrent Instability / Re-injury
时间窗: 24 months after surgery
Recurrent instability will consist of any of the following events: dislocation, subluxation, revision stabilization procedure.
次要结局
- Single Assessment Numerical Evaluation (SANE)(24 months after surgery)
- Patient-Reported Outcome Measurement Information System (PROMIS) Global-10(24 months after surgery)
- Tampa Scale for Kinesiophobia-11 (TSK-11)(24 months after surgery)
- Performance on Functional Tests of the Upper Extremity - Upper Quarter Y-Balance test(6 months after surgery)
- Clinical Measures after Surgical Stabilization - Pain(12 months after surgery)
- Clinical Measures after Surgical Stabilization - Pain Medication Usage(12 months after surgery)
- Clinical Measures after Surgical Stabilization - Use of Post-op Brace(12 months after surgery)
- Clinical Measures after Surgical Stabilization - Wound Status(12 months after surgery)
- Clinical Measures after Surgical Stabilization - Neurovascular status(12 months after surgery)
- Clinical Measures after Surgical Stabilization - Additional Diagnostic Tests(12 months after surgery)
- Functional Comorbidity Index(24 months after surgery)
- Passive Range of Motion of the Shoulder(6 months after surgery)
- Isometric Muscle Strength of the Shoulder(6 months after surgery)
- Performance on Functional Tests of the Upper Extremity - Closed Kinetic Chain Upper Extremity Stability test(6 months after surgery)
- Performance on Functional Tests of the Upper Extremity - Unilateral Seated Shot-Put test(6 months after surgery)
- Performance on Functional Tests of the Upper Extremity - Push-ups(6 months after surgery)
- Performance on Functional Tests of the Upper Extremity - Weighted Overhead Ball Throw(6 months after surgery)
- Single Assessment Numerical Evaluation (SANE)(24 months after surgery)
- Brophy Shoulder Activity Level(24 months after surgery)
- Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) - Upper Extremity (UE)(24 months after surgery)
- Patient-Reported Outcome Measurement Information System (PROMIS) Global-10(24 months after surgery)
- Tampa Scale for Kinesiophobia-11 (TSK-11)(24 months after surgery)
- Brief Resilience Scale(24 months after surgery)
- Patient Acceptable Symptom State (PASS)(24 months after surgery)
- Functional Comorbidity Index(24 months after surgery)
- Passive Range of Motion of the Shoulder(6 months after surgery)
- Isometric Muscle Strength of the Shoulder(6 months after surgery)
- Performance on Functional Tests of the Upper Extremity - Closed Kinetic Chain Upper Extremity Stability test(6 months after surgery)
- Performance on Functional Tests of the Upper Extremity - Unilateral Seated Shot-Put test(6 months after surgery)
- Performance on Functional Tests of the Upper Extremity - Push-ups(6 months after surgery)
- Performance on Functional Tests of the Upper Extremity - Weighted Overhead Ball Throw(6 months after surgery)
- Performance on Functional Tests of the Upper Extremity - Upper Quarter Y-Balance test(6 months after surgery)
- Clinical Measures after Surgical Stabilization - Pain(12 months after surgery)
- Clinical Measures after Surgical Stabilization - Pain Medication Usage(12 months after surgery)
- Clinical Measures after Surgical Stabilization - Use of Post-op Brace(12 months after surgery)
- Clinical Measures after Surgical Stabilization - Wound Status(12 months after surgery)
- Clinical Measures after Surgical Stabilization - Neurovascular status(12 months after surgery)
- Clinical Measures after Surgical Stabilization - Additional Diagnostic Tests(12 months after surgery)
研究者
Adam Popchak
Associate Professor
University of Pittsburgh