Clinical trial NCT00477360: Humeral Resurfacing Hemiarthroplasty
Official title: Humeral Resurfacing Hemiarthroplasty. Phase 2: Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Advanced Glenohumeral Arthritis
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: DePuy International
name: Johnson & Johnson
First posted: 2007-05-23
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: American Shoulder And Elbow Surgeons Shoulder Index (ASES)
timeFrame: 24 months post-operative
Secondary outcomes:
measure: Constant Score
timeFrame: 24 months post-operative
measure: Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
timeFrame: 24 months post-operative
measure: Simple Shoulder Test (SST)
timeFrame: 24 months post-operative
measure: Radiographic Evaluation
timeFrame: 3 months + yearly post-operative
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary Sport Medicine Centre
state: Alberta
Study officials:
affiliation: University of Calgary
name: Dr. Richard Boorman
role: PRINCIPAL_INVESTIGATOR
affiliation: Western University, Canada
name: Dr. Dianne Bryant
role: PRINCIPAL_INVESTIGATOR
References: