Arthroscopic Electrothermal Capsulorrhaphy, ETAC, Versus Open Inferior Capsular Shift, ICS in Patients With Shoulder Instability: A Multicentre Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 14
- 主要终点
- Western Ontario Shoulder Instability (WOSI) Index
研究概览
简要总结
This trial will compare the effectiveness of electrothermal arthroscopic capsulorrhaphy (ETAC) to the current reference standard procedure, open inferior capsular shift (ICS), for the treatment of shoulder instability caused by ligamentous capsular redundancy. Multi-directional instability (MDI) and multi-directional laxity with anteroinferior instability (MDL-AII) are the two types of shoulder instabilities included in this trial.
Hypothesis: There is no difference in disease-specific quality of life between patients undergoing an ETAC versus an open ICS for the treatment of shoulder instability caused by capsular ligamentous redundancy.
详细描述
The shoulder is the most frequently dislocated joint in the body. Multiple causes and pathologies account for the various types of shoulder instability. Multi-directional instability (MDI) and multi-directional laxity with anteroinferior instability (MDL-AII) are similar in pathology, less common and more difficult to treat. These types of shoulder instability are caused by ligamentous capsular redundancy. When non-operative management fails for these patients, their quality of life is significantly impaired and surgical treatment is required to tighten the loose ligaments and joint capsule. A new way to treat these patients involves arthroscopic thermal shrinkage of the tissue to tighten the joint. However, there is a lack of scientific evidence to support the use of this technique called, electrothermal arthroscopic capsulorrhaphy (ETAC). The current reference (gold) standard treatment for these patients is an open inferior capsular shift (ICS) procedure. Therefore, this trial will compare the effectiveness of these surgical techniques (ETAC vs. ICS) in patients with MDI and MDL-AII by determining patient related quality of life.
This study is designed as a multicentre, randomized controlled trial. Patients diagnosed with either MDI or MDL-AII who failed standardized non-operative management will undergo a diagnostic shoulder arthroscopy, and if appropriate, will be subsequently randomized in the operating room to either an ETAC or ICS surgical procedure. Computer-generated, stratified block randomization is used. Stratification is based on two variables:
- surgeon - to account for any differences between surgeons, and
- diagnosis (MDI or MDL-AII) - to account for any differences in the severity of pathology.
The disease-specific quality of life is assessed using a validated questionnaire, the Western Ontario Shoulder Instability Index, measured at baseline, and 3, 6, 12 and 24 months. The WOSI index has 21 questions, divided into four categories to assess physical symptoms, sport/recreation/work, lifestyle and emotions. Each question is scored out of 100 using a visual analog scale response format. A lower score reflects a better quality of life.
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
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 14 years or greater
- •Diagnosis of MDI or MDL-AII. Diagnosis will require two or more of the following:
- •Symptomatic translation (pain or discomfort) in one or more directions: anterior, inferior and/or posterior;
- •Ability to elicit unwanted glenohumeral translations that reliably produce symptoms with one of the following tests: the anterior and posterior apprehension tests, the anterior and posterior load and shift tests, the fulcrum test, the relocation test, the Fukuda test, and/or the push-pull or stress test with the patient supine;
- •Presence of a positive sulcus sign of 1 centimetre or greater gap that reproduces the patient's clinical symptoms of instability and should be both palpable and visible;
- •Symptoms of instability: subluxation or dislocation.
- •Written informed consent
- •Failed at least 6 months of non-operative treatment
- •Confirmed capsular-ligamentous redundancy as determined by diagnostic arthroscopy examination.
排除标准
- •Neurologic disorder (ie: axillary nerve injury; syringomyelia)
- •Cases involving third party compensation
- •Patients with primary posterior instability
- •A bony abnormality (Hill Sachs/bony Bankart) on standard series of x-rays consisting of a minimum of an anteroposterior view, lateral in the scapular plane and an axillary view
- •Presence of a Bankart lesion on arthroscopic exam of the joint
- •Presence of an unstable biceps anchor (ie: superior labral anterior and posterior [SLAP] lesion) on arthroscopic exam of the joint
- •Presence of a full-thickness rotator cuff tear.
结局指标
主要结局
Western Ontario Shoulder Instability (WOSI) Index
时间窗: Baseline, 3, 6, 12, 24 months post-operatively
次要结局
- Constant score (European Shoulder Society)(Baseline, 3, 6, 12, 24 months post-operatively)
- Complications(Intra-operatively and up to 8 weeks post-operatively)
- Recurrent instability(Up to 24 months post-operatively)
- Operative time(Day of surgery)
- American Shoulder and Elbow Surgeon's Score (ASES)(Baseline, 3, 6, 12, 24 months post-operatively)
研究者
Dr. Nicholas Mohtadi
Clinical Associate Professor
University of Calgary