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

NCT00251160 | Completed DMC

• 3 other identifiers: 10650MCT-64671 (CIHR)ISRCTN68224911
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 7

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.

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

Outcome Measures

Primary Outcomes (1)

• Western Ontario Shoulder Instability (WOSI) Index

  Baseline, 3, 6, 12, 24 months post-operatively

Secondary Outcomes (5)

• Constant score (European Shoulder Society)

  Baseline, 3, 6, 12, 24 months post-operatively

• Recurrent instability

  Up to 24 months post-operatively

• Complications

  Intra-operatively and up to 8 weeks post-operatively

• Operative time

  Day of surgery

• American Shoulder and Elbow Surgeon's Score (ASES)

  Baseline, 3, 6, 12, 24 months post-operatively

Study Arms (2)

ETAC

ACTIVE COMPARATOR

Procedure: Electrothermal arthroscopic capsulorrhaphy (ETAC)

Open ICS

ACTIVE COMPARATOR

Procedure: Open inferior capsular shift (ICS)

Interventions

Electrothermal arthroscopic capsulorrhaphy (ETAC) PROCEDURE

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.

Also known as: Heat probe

ETAC

Open inferior capsular shift (ICS) PROCEDURE

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.

Also known as: Open inferior capsular shift

Open ICS

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• The Arthritis Society, Canada: collaborator
• Smith and Nephew (formerly Oratec Interventions): collaborator

Study Sites (7)

University of Calgary Sport Medicine Centre

Calgary, Alberta, T2N 1N4, Canada

Location

Grey Nuns Community Hospital

Edmonton, Alberta, T6L 5X8, Canada

Location

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

Location

Pan Am Medical and Surgical Centre

Winnipeg, Manitoba, R3M 3E4, Canada

Location

Hamilton General Hospital

Hamilton, Ontario, L8L 5G8, Canada

Location

Fowler Kennedy Sport Medicine Centre

London, Ontario, N6A 3K7, Canada

Location

St. Joseph's Health Centre

London, Ontario, N6A 4L6, Canada

Location

Related Publications (2)

• 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.

  PMID: 16542033 BACKGROUND

• 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.

  PMID: 24939380 RESULT

Related Links

• Study protocol and Lessons learned from conducting a multi-centre RCT, in online journal "Trials"

MeSH Terms

Conditions

Shoulder Dislocation; Joint Instability

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Shoulder Injuries

Study Officials

• Nicholas Mohtadi, MD, FRCSC

  University of Calgary Sport Medicine Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: November 7, 2005
• First Posted: November 9, 2005
• Study Start: December 1, 1999
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: July 13, 2015

Record last verified: 2015-07

Locations

CA (7)