Comparing Two Surgical Methods of Fixation of Subscapularis During Shoulder Arthroplasty

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2011-12-31

Brief Summary

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This pilot study is being conducted to compare 2 methods of access to the shoulder for arthroplasty in patients with Osteoarthritis as we do not know has a better outcome.

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Detailed Description

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The study investigates the difference in disease specific quality of life between patients who undergo a subscapularis peel versus morselized osteotomy of the lesser tuberosity, as measured by the Western Ontario Osteoarthritis of the Shoulder (WOOS) at one year post-operatively in patients who undergo shoulder arthroplasty ?

Conditions

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Subscapularis Peel Morselized Osteotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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subscapularis peel

Group Type ACTIVE_COMPARATOR

subscapularis peel

Intervention Type PROCEDURE

Detachment of the subscapularis tendon from its insertion on the lesser tuberosity "the peel".

osteotomy

Group Type ACTIVE_COMPARATOR

osteotomy

Intervention Type PROCEDURE

This group will use a technique that involves elevation of the tendon with a wafer of bone in order to gain access to the shoulder.

Interventions

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subscapularis peel

Detachment of the subscapularis tendon from its insertion on the lesser tuberosity "the peel".

Intervention Type PROCEDURE

osteotomy

This group will use a technique that involves elevation of the tendon with a wafer of bone in order to gain access to the shoulder.

Intervention Type PROCEDURE

Other Intervention Names

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non applicable non applicable

Eligibility Criteria

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Inclusion Criteria

* Patients who have failed standard non-surgical management of their shoulder arthritis who would benefit from a shoulder arthroplasty.

Exclusion Criteria

* Active joint or systemic infection
* Significant muscle paralysis
* Rotator cuff tear arthroplasty
* Major medical illness
* Unable to speak or read English/French
* Psychiatric illness that precludes informed consent
* Unwilling to be followed for 1 year

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No