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Electrothermal Arthroscopic Capsulorrhaphy (ETAC) and Open Inferior Capsular Shift in Patients With Shoulder Instability

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ClinicalTrials.gov Identifier: NCT00251160
Recruitment Status : Completed
First Posted : November 9, 2005
Last Update Posted : July 13, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Shoulder Dislocation Procedure: Electrothermal arthroscopic capsulorrhaphy (ETAC) Procedure: Open inferior capsular shift (ICS)

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Arthroscopic Electrothermal Capsulorrhaphy, ETAC, Versus Open Inferior Capsular Shift, ICS in Patients With Shoulder Instability: A Multicentre Randomized Clinical Trial
Study Start Date : December 1999
Primary Completion Date : February 2010
Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: ETAC Procedure: Electrothermal arthroscopic capsulorrhaphy (ETAC)
The Oratec Vulcan Generator electro-thermal system (Oratec Interventions Inc., Menlo Park, CA, USA) delivers heat at 75C and 40 watts. An anterior portal is established above the superior border of the subscapularis tendon. For MDI patients, the heat probe is introduced through the posterior portal. The capsule is shrunk using a grid pattern until excess volume is diminished. The extent of the heat probe application is identical to the landmarks used for the open ICS. Care is taken to avoid applying heat to the capsule in the region from 5-7 o'clock within 1cm of the glenoid rim to avoid the axillary nerve. The method of heat application utilizes a grid pattern, which is less likely to cause dissolution of the capsule and subsequent catastrophic capsular loss.
Other Name: Heat probe
Active Comparator: Open ICS Procedure: Open inferior capsular shift (ICS)
MDI: lateral capsule released antero-superiorly from rotator interval to equator, posteriorly on the humeral neck. MDL-AII: release from the rotator interval to 7 o'clock (Right) or 5 o'clock (Left) position on humeral neck, to tighten the 2 bands of the inferior GH ligaments, middle GH ligament and rotator interval. Bone adjacent to the articular surface on the surgical neck of the humerus is roughened to create a bleeding bony bed. With the arm in 0deg flexion, 30deg abduction, 30deg external rotation, the inferior leaflet of the capsule is shifted superiorly and slightly laterally, and sutured to the rim of the capsule using a non-absorbable suture. Superior leaflet is shifted inferiorly and sutured. Subscapularis is repaired at its anatomic length using interrupted sutures.
Other Name: Open inferior capsular shift

Outcome Measures

Primary Outcome Measures :
  1. Western Ontario Shoulder Instability (WOSI) Index [ Time Frame: Baseline, 3, 6, 12, 24 months post-operatively ]

Secondary Outcome Measures :
  1. Constant score (European Shoulder Society) [ Time Frame: Baseline, 3, 6, 12, 24 months post-operatively ]
  2. Recurrent instability [ Time Frame: Up to 24 months post-operatively ]
  3. Complications [ Time Frame: Intra-operatively and up to 8 weeks post-operatively ]
  4. Operative time [ Time Frame: Day of surgery ]
  5. American Shoulder and Elbow Surgeon's Score (ASES) [ Time Frame: Baseline, 3, 6, 12, 24 months post-operatively ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00251160

Canada, Alberta
University of Calgary Sport Medicine Centre
Calgary, Alberta, Canada, T2N 1N4
Grey Nuns Community Hospital
Edmonton, Alberta, Canada, T6L 5X8
Canada, British Columbia
Royal Columbian Hospital
New Westminster, British Columbia, Canada, V3L 3W7
Canada, Manitoba
Pan Am Medical and Surgical Centre
Winnipeg, Manitoba, Canada, R3M 3E4
Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 5G8
Fowler Kennedy Sport Medicine Centre
London, Ontario, Canada, N6A 3K7
St. Joseph's Health Centre
London, Ontario, Canada, N6A 4L6
Sponsors and Collaborators
University of Calgary
Canadian Institutes of Health Research (CIHR)
The Arthritis Society, Canada
Smith and Nephew (formerly Oratec Interventions)
Principal Investigator: Nicholas Mohtadi, MD, FRCSC University of Calgary Sport Medicine Centre
More Information

Additional Information:
Responsible Party: Dr. Nicholas Mohtadi, Clinical Associate Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT00251160     History of Changes
Other Study ID Numbers: 10650
MCT-64671 (CIHR) ( Other Grant/Funding Number: Canadian Institutes of Health Research )
ISRCTN68224911 ( Registry Identifier: Current Controlled Trials )
First Posted: November 9, 2005    Key Record Dates
Last Update Posted: July 13, 2015
Last Verified: July 2015

Keywords provided by Dr. Nicholas Mohtadi, University of Calgary:
Multi-directional instability
Ligamentous laxity
Multi-directional laxity
Shoulder instability
electrothermal capsulorrhaphy, ETAC
inferior capsular shift, ICS
capsular redundancy

Additional relevant MeSH terms:
Shoulder Dislocation
Joint Dislocations
Bone Diseases
Musculoskeletal Diseases
Wounds and Injuries
Shoulder Injuries