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

NCT00251160 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2015-07-13

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • The Arthritis Society, Canada

    collaborator OTHER

  • Smith and Nephew (formerly Oratec Interventions)

    collaborator UNKNOWN

  • University of Calgary

    lead OTHER

Principal Investigators

  • Nicholas Mohtadi, MD, FRCSC · University of Calgary Sport Medicine Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-12-31
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00251160 on ClinicalTrials.gov