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

Sponsors and Collaborators:	University of Calgary Canadian Institutes of Health Research (CIHR) The Arthritis Society Smith & Nephew, Inc. Oratec Interventions
Information provided by:	University of Calgary
ClinicalTrials.gov Identifier:	NCT00251160

Purpose

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	Intervention
Shoulder Dislocation	Procedure: Electrothermal arthroscopic capsulorrhaphy (ETAC) Procedure: Open inferior capsular shift (ICS)

MedlinePlus related topics: Dislocations Shoulder Injuries and Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Arthroscopic Electrothermal Capsulorrhaphy, ETAC, Versus Open Inferior Capsular Shift, ICS in Patients With Shoulder Instability: A Multicentre Randomized Clinical Trial

Further study details as provided by University of Calgary:

Primary Outcome Measures:

Western Ontario Shoulder Instability (WOSI) Index [ Time Frame: Baseline, 3, 6, 12, 24 months post-operatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Constant score (European Shoulder Society) [ Time Frame: Baseline, 3, 6, 12, 24 months post-operatively ] [ Designated as safety issue: No ]
Recurrent instability [ Time Frame: Up to 24 months post-operatively ] [ Designated as safety issue: No ]
Complications [ Time Frame: Intra-operatively and up to 8 weeks post-operatively ] [ Designated as safety issue: Yes ]
Operative time [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]
American Shoulder and Elbow Surgeon's Score (ASES) [ Time Frame: Baseline, 3, 6, 12, 24 months post-operatively ] [ Designated as safety issue: No ]

Estimated Enrollment:	58
Study Start Date:	December 1999
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
ETAC: Active Comparator	Procedure: Electrothermal arthroscopic capsulorrhaphy (ETAC) The Oratec Vulcan Generator electro-thermal system (Oratec Interventions Inc., Menlo Park, CA, USA) is 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.
Open ICS: Active Comparator	Procedure: Open inferior capsular shift (ICS) For MDI patients, the lateral capsule is released antero-superiorly from the rotator interval to the equator posteriorly on the humeral neck. For MDL-AII patients, release extends from the rotator interval to the 7 o'clock position (Right) or 5 o'clock position (Left) on the humeral neck, to tighten the two 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 0 deg flexion, 30 deg abduction, 30 deg 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. The superior leaflet is shifted inferiorly and sutured. The subscapularis is repaired at its anatomic length using interrupted sutures.

Arms

Assigned Interventions

ETAC: Active Comparator

Procedure: Electrothermal arthroscopic capsulorrhaphy (ETAC)

The Oratec Vulcan Generator electro-thermal system (Oratec Interventions Inc., Menlo Park, CA, USA) is 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.

Open ICS: Active Comparator

Procedure: Open inferior capsular shift (ICS)

For MDI patients, the lateral capsule is released antero-superiorly from the rotator interval to the equator posteriorly on the humeral neck. For MDL-AII patients, release extends from the rotator interval to the 7 o'clock position (Right) or 5 o'clock position (Left) on the humeral neck, to tighten the two 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 0 deg flexion, 30 deg abduction, 30 deg 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. The superior leaflet is shifted inferiorly and sutured. The subscapularis is repaired at its anatomic length using interrupted sutures.

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:

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.

Eligibility

Ages Eligible for Study:	14 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00251160

Locations

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
Fowler Kennedy Sport Medicine Centre
London, Ontario, Canada, N6A 3K7
St. Joseph's Health Centre
London, Ontario, Canada, N6A 4L6
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 5G8

Sponsors and Collaborators

University of Calgary

Canadian Institutes of Health Research (CIHR)

The Arthritis Society

Smith & Nephew, Inc.

Oratec Interventions

Investigators

Principal Investigator:

Nicholas Mohtadi, MD, FRCSC

University of Calgary Sport Medicine Centre

More Information

Study protocol and Lessons learned from conducting a multi-centre RCT, in online journal "Trials" This link exits the ClinicalTrials.gov site

Publications:

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.

Responsible Party:	University of Calgary ( Denise Chan, Orthopaedic Research Coordinator )
Study ID Numbers:	10650, MCT-64671 (CIHR)
Study First Received:	November 7, 2005
Last Updated:	July 9, 2008
ClinicalTrials.gov Identifier:	NCT00251160
Health Authority:	Canada: Health Canada

Keywords provided by University of Calgary:

Multi-directional instability
MDI
Ligamentous laxity
Multi-directional laxity
MDL-AII

Shoulder instability
electrothermal capsulorrhaphy, ETAC
inferior capsular shift, ICS
capsular redundancy

Study placed in the following topic categories:

Dislocations
Wounds and Injuries
Shoulder Dislocation
Disorders of Environmental Origin
Arm Injuries

ClinicalTrials.gov processed this record on January 16, 2009