Humeral Resurfacing Hemiarthroplasty

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

Detailed Description
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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.

Official Title
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Humeral Resurfacing Hemiarthroplasty. Phase 2: Prospective Cohort Study

Conditions
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Advanced Glenohumeral Arthritis

Intervention / Treatment
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* Device: Humeral surface replacement hemiarthroplasty (CAP)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>C.A.P | Device: Humeral surface replacement hemiarthroplasty (CAP)<br>* C.A.P hemiarthroplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Shoulder And Elbow Surgeons Shoulder Index (ASES) |  | 24 months post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant Score |  | 24 months post-operative | 
| Western Ontario Osteoarthritis of the Shoulder Index (WOOS) |  | 24 months post-operative | 
| Simple Shoulder Test (SST) |  | 24 months post-operative | 
| Radiographic Evaluation |  | 3 months + yearly post-operative |