Overview

This trial is active, not recruiting.

Condition advanced glenohumeral arthritis
Treatment humeral surface replacement hemiarthroplasty (cap)
Sponsor University of Calgary
Collaborator DePuy International
Start date January 2007
End date February 2013
Trial size 30 participants
Trial identifier NCT00477360, 15052007

Summary

The primary objective of this study is to examine quality of life outcomes in patients who have undergone a humeral surface replacement hemiarthroplasty.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
C.A.P
humeral surface replacement hemiarthroplasty (cap)
C.A.P hemiarthroplasty

Primary Outcomes

Measure
American Shoulder And Elbow Surgeons Shoulder Index (ASES)
time frame: 24 months post-operative

Secondary Outcomes

Measure
Constant Score
time frame: 24 months post-operative
Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
time frame: 24 months post-operative
Simple Shoulder Test (SST)
time frame: 24 months post-operative
Radiographic Evaluation
time frame: 3 months + yearly post-operative

Eligibility Criteria

Male or female participants of any age.

Pre-Operative Inclusion Criteria: - Failed standard non-surgical management (analgesics, nsaids, physiotherapy, activity modification) - Persistent pain and disability for at least 6 months - Imaging demonstrates advanced humeral head cartilage loss Pre-Operative Exclusion Criteria: - Active or systemic joint infection - Significant muscle paralysis of shoulder girdle - Charcot's Arthropathy - Major medical illness (life expectancy <2years) - Unable to speak and read English/French - Psychiatric illness that precludes informed consent - Unwilling/unable to remain in study for one year Intra-Operative Inclusion Criteria: Advanced humeral head cartilage loss AND ONE of: - minimal/no glenoid cartilage loss - complete glenoid cartilage loss and no bony erosion - complete glenoid cartilage loss and concentric bony erosion with no humeral anterior/posterior subluxation Intra-Operative Exclusion Criteria: - Eccentric glenoid erosion with biconcavity of glenoid and subluxation of humeral head - Inability of humeral head to support the CAP surface replacement

Additional Information

Official title Humeral Resurfacing Hemiarthroplasty. Phase 2: Prospective Cohort Study
Principal investigator Dr. Richard Boorman
Description Resurfacing arthroplasty is gaining popularity for the reconstruction of advanced shoulder arthritis. New generation re-surfacing prostheses are engineered to anatomically restore a smooth articulating surface to the humeral head, while preserving bone stock, and potentially minimizing the risk for diaphyseal fracture. The results for shoulder resurfacing prostheses have largely been reported in retrospective reviews and have been very favorable. The purpose of this multi-centered, prospective study will be to determine the extent to which patient self-assessed outcomes (American Shoulder and Elbow Society (ASES) Score) following humeral resurfacing improve compared to pre-operative ASES scores.
Trial information was received from ClinicalTrials.gov and was last updated in August 2011.
Information provided to ClinicalTrials.gov by University of Calgary.