Clinical trial NCT00251160: Electrothermal Arthroscopic Capsulorrhaphy (ETAC) and Open Inferior Capsular Shift in Patients With Shoulder Instability
Official title: Arthroscopic Electrothermal Capsulorrhaphy, ETAC, Versus Open Inferior Capsular Shift, ICS in Patients With Shoulder Instability: A Multicentre Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Dislocation
Keywords: Multi-directional instability
MDI
Ligamentous laxity
Multi-directional laxity
MDL-AII
Shoulder instability
electrothermal capsulorrhaphy, ETAC
inferior capsular shift, ICS
capsular redundancy
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: The Arthritis Society, Canada
name: Smith and Nephew (formerly Oratec Interventions)
First posted: 2005-11-09
Enrollment: 58
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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:

1. surgeon - to account for any differences between surgeons, and
2. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Western Ontario Shoulder Instability (WOSI) Index
timeFrame: Baseline, 3, 6, 12, 24 months post-operatively
Secondary outcomes:
measure: Constant score (European Shoulder Society)
timeFrame: Baseline, 3, 6, 12, 24 months post-operatively
measure: Recurrent instability
timeFrame: Up to 24 months post-operatively
measure: Complications
timeFrame: Intra-operatively and up to 8 weeks post-operatively
measure: Operative time
timeFrame: Day of surgery
measure: American Shoulder and Elbow Surgeon's Score (ASES)
timeFrame: Baseline, 3, 6, 12, 24 months post-operatively
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary Sport Medicine Centre
state: Alberta
city: Edmonton
country: Canada
facility: Grey Nuns Community Hospital
state: Alberta
city: New Westminster
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: Pan Am Medical and Surgical Centre
state: Manitoba
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: London
country: Canada
facility: Fowler Kennedy Sport Medicine Centre
state: Ontario
city: London
country: Canada
facility: St. Joseph's Health Centre
state: Ontario
Study officials:
affiliation: University of Calgary Sport Medicine Centre
name: Nicholas Mohtadi, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mohtadi NG, Hollinshead RM, Ceponis PJ, Chan DS, Fick GH. A multi-centre randomized controlled trial comparing electrothermal arthroscopic capsulorrhaphy versus open inferior capsular shift for patients with shoulder instability: protocol implementation and interim performance: lessons learned from conducting a multi-centre RCT [ISRCTN68224911; NCT00251160]. Trials. 2006 Feb 2;7:4. doi: 10.1186/1745-6215-7-4.
citation: Mohtadi NG, Kirkley A, Hollinshead RM, McCormack R, MacDonald PB, Chan DS, Sasyniuk TM, Fick GH, Paolucci EO; Joint Orthopaedic Initiative for National Trials of the Shoulder-Canada. Electrothermal arthroscopic capsulorrhaphy: old technology, new evidence. A multicenter randomized clinical trial. J Shoulder Elbow Surg. 2014 Aug;23(8):1171-80. doi: 10.1016/j.jse.2014.02.022. Epub 2014 Jun 15.