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

NACompletedINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

December 31, 1999

Primary Completion Date

February 28, 2010

Study Completion Date

February 28, 2010

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.

Trial Locations (7)

T2N 1N4

University of Calgary Sport Medicine Centre, Calgary

T6L 5X8

Grey Nuns Community Hospital, Edmonton

V3L 3W7

Royal Columbian Hospital, New Westminster

R3M 3E4

Pan Am Medical and Surgical Centre, Winnipeg

L8L 5G8

Hamilton General Hospital, Hamilton

N6A 3K7

Fowler Kennedy Sport Medicine Centre, London

N6A 4L6

St. Joseph's Health Centre, London

All Listed Sponsors
collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

collaborator

The Arthritis Society, Canada

OTHER

collaborator

Smith and Nephew (formerly Oratec Interventions)

UNKNOWN

lead

University of Calgary

OTHER

NCT00251160 - Electrothermal Arthroscopic Capsulorrhaphy (ETAC) and Open Inferior Capsular Shift in Patients With Shoulder Instability | Biotech Hunter | Biotech Hunter