Humeral Resurfacing Hemiarthroplasty
- Conditions
- Advanced Glenohumeral Arthritis
- Interventions
- Device: Humeral surface replacement hemiarthroplasty (CAP)
- Registration Number
- NCT00477360
- Lead Sponsor
- University of Calgary
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Humeral surface replacement hemiarthroplasty (CAP) C.A.P
- Primary Outcome Measures
Name Time Method American Shoulder And Elbow Surgeons Shoulder Index (ASES) 24 months post-operative
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
University of Calgary Sport Medicine Centre
🇨🇦Calgary, Alberta, Canada