The Effect of Arthroscopic Bankart Repair on Anterior-posterior Glenohumeral Translation and Shoulder Proprioception in Patients With Traumatic Anterior Shoulder Instability: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in anterior-posterior glenohumeral translation (range in millimeters)
研究概览
简要总结
The purpose of the study is to investigate biomechanical and proprioceptive conditions in patients with symptomatic traumatic anterior shoulder instability undergoing arthroscopic Bankart repair. To determine these, non-invasive and non-irradiating examination methods that have been proven valid and reliable will be used in a combination that has not been reported before. The objective is to determine whether the anatomical reconstruction affects biomechanical and proprioceptive measures in the traumatic unstable shoulder. The study will also investigate patient-reported and clinical outcomes.
The hypotheses are that the intervention improves biomechanical and proprioceptive conditions to the near-normal state, as measured after both 6 and 12 months. Further, hypotheses are that the intervention leads to improved patient-reported and clinical outcomes.
详细描述
• Aim: To investigate the effect of arthroscopic Bankart repair on shoulder biomechanics and proprioception, and increase understanding of traumatic anterior shoulder instability.
• Main research questions: A (biomechanics): Does arthroscopic Bankart repair have a stabilising effect on the anterior-posterior glenohumeral translation in patients with traumatic anterior shoulder instability? B (proprioception): Does arthroscopic Bankart repair improve neuromuscular control in patients with traumatic anterior shoulder instability?
• Objectives and hypotheses research question A: In patients with traumatic anterior shoulder instability undergoing arthroscopic Bankart repair, to investigate the anterior-posterior glenohumeral translation and the scapular rotations before and six and twelve months after surgery and whether the ranges are restored to the same as the non-injured contralateral shoulder.
Hypotheses:
- Arthroscopic Bankart repair results in a ≥2.5 mm decrease in anterior-posterior glenohumeral translation, remaining both six and twelve months after surgery.
- Arthroscopic Bankart repair reduces anterior-posterior glenohumeral translation to the same range as measured in the non-injured shoulder (±2.5 mm).
- Arthroscopic Bankart repair reduces superior-inferior glenohumeral translation significantly, as measured six and twelve months after surgery.
- Scapular rotations and tilt remain unchanged after arthroscopic Bankart repair.
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
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-40 years
- •Unilateral traumatic anterior shoulder instability booked for arthroscopic Bankart repair according to the department's guidelines (extent of symptoms, suffer recurrent dislocations, positive apprehension and relocation test, limited bone loss)
- •Willing to adhere to the study protocol, herein attend follow-up
- •The patient must be able to speak and understand Danish
- •The patient must be able to give written informed consent
排除标准
- •Traumatic instability in the opposite shoulder
- •For one or both shoulders: posterior, multi-directional or atraumatic instability
- •For one or both shoulders: traumatic rotator cuff or biceps tendon tear, Superior Labrum from Anterior to Posterior tear (SLAP-lesion)
- •For one or both shoulders: traumatic fracture of proximal humerus (other than Hill-Sachs lesion), clavicula, scapula (other than glenoid) or dislocation of sternoclavicular or acromioclavicular joints
- •For one or both shoulders: atraumatic shoulder pathologies (e.g. frozen shoulder, symptomatic osteoarthritis of the shoulder or acromioclavicular joints, acute calcific tendinitis)
- •Pregnancy
- •Terminal illness or severe medical illness: American Society of Anesthesiology (ASA) score ≥3.
结局指标
主要结局
Change in anterior-posterior glenohumeral translation (range in millimeters)
时间窗: baseline, 6 months
The effect of Bankart repair on anterior-posterior glenohumeral translation, measured 6 months after intervention and compared to pre-interventional. The translation will be measured using ultrasound examination.
次要结局
- Change in anterior-posterior glenohumeral translation (range in millimeters)(baseline, 12 months)
- Change in neuromuscular control (as assessed with the Copenhagen Assessment of Neuromuscular Control in the Unstable Shoulder (CANCUS) protocol).(baseline, 6 months, 12 months)
- Change in superior-inferior glenohumeral translation (range in millimeters)(baseline, 6 months, 12 months)
- Change in scapular rotations (degrees)(baseline, 6 months, 12 months)
研究者
Catarina Malmberg
MD
Copenhagen University Hospital, Hvidovre