Status:

COMPLETED

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

Lead Sponsor:

University of Calgary

Collaborating Sponsors:

Canadian Institutes of Health Research (CIHR)

The Arthritis Society, Canada

Conditions:

Shoulder Dislocation

Eligibility:

All Genders

14+ years

Phase:

NA

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 sho...

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-d...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

December 1 1999

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2010

Estimated Enrollment :

58 Patients enrolled

Trial Details

Trial ID

NCT00251160

Start Date

December 1 1999

End Date

February 1 2010

Last Update

July 13 2015

Active Locations (7)

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Page 1 of 2 (7 locations)

1

University of Calgary Sport Medicine Centre

Calgary, Alberta, Canada, T2N 1N4

2

Grey Nuns Community Hospital

Edmonton, Alberta, Canada, T6L 5X8

3

Royal Columbian Hospital

New Westminster, British Columbia, Canada, V3L 3W7

4

Pan Am Medical and Surgical Centre

Winnipeg, Manitoba, Canada, R3M 3E4

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