Status:
COMPLETED
Cemented vs. Non-Cemented TSA for OA of the Shoulder
Lead Sponsor:
Fowler Kennedy Sport Medicine Clinic
Collaborating Sponsors:
Zimmer Biomet
Conditions:
Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to investigate the fixation of the humeral component in total shoulder arthroplasty for primary osteoarthritis of the glenohumeral joint.Our hypothesis is that uncemented f...
Detailed Description
Currently, cement fixation of the humeral component is recommended as the standard of care and review of the literature indicates that this fixation is associated with a low complication rate. Uncemen...
Eligibility Criteria
Inclusion
- Primary osteoarthritis of the shoulder of grade III or higher (Kellgren and Lawrence modified for the shoulder
- Patients who have failed standard conservative management of their shoulder osteoarthritis
Exclusion
- Patients with secondary OA resulting from major joint trauma, infection, avascular necrosis, cuff tear arthropathy, chronic dislocation, massive rotator cuff tear, inflammatory arthropathy, Charcot's arthropathy or previous shoulder surgery (other than arthroscopic debridement)
- Patients with preoperative CT scans of the shoulder which show insufficient glenoid bone stock that would not allow for implantation of a glenoid prosthesis
- Active joint or systemic infection
- Significant muscle paralysis
- Major medical illness (life expectancy less then 2yrs or unacceptably high operative risk)
- Unable to speak or read English/French
- Psychiatric illness that precludes informed consent
- Unwilling to be followed for 2 years
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
End Date :
August 1 2008
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00158418
Start Date
August 1 2002
End Date
August 1 2008
Last Update
January 29 2009
Active Locations (1)
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1
Fowler Kennedy Sport Medicine Clinic
London, Ontario, Canada, N6A 3K7