Status:
COMPLETED
Roentgen Stereophotogrammetric Analysis (RSA) to Evaluate Fixation of Biofoam Advance Total Knee Arthroplasty Components
Lead Sponsor:
Dalhousie University
Collaborating Sponsors:
Stryker Trauma and Extremities
Conditions:
Osteoarthritis
Eligibility:
All Genders
21-80 years
Phase:
NA
Brief Summary
Hip and knee replacement arthroplasty are profoundly successful operative interventions, however, some joint replacements do fail and the life expectancy of a hip or knee arthroplasty is finite. This ...
Detailed Description
Hip and knee replacement arthroplasty are profoundly successful operative interventions, however, some joint replacements do fail and the life expectancy of a hip or knee arthroplasty is finite. This ...
Eligibility Criteria
Inclusion
- Symptomatic osteoarthritis of the knee indicating surgical intervention
- Between the ages of 21 and 80 inclusive
- Ability to give informed consent
Exclusion
- Significant co-morbidity affecting ability to ambulate
- Flexion contracture greater than 15°
- Extension lag greater than 10°
- Tibial subluxation greater than 10 mm on standing AP radiograph
- Prior arthroplasty, patellectomy or osteotomy with the affected knee
- Lateral or medial collateral ligament instability (\> 10° varus/valgus)
- Leg length discrepancy greater than 10 mm
- Active or prior infection
- Morbid Obesity (BMI \> 40)
- Medical condition precluding major surgery
- Severe osteoporosis or osteopenia
- Neuromuscular impairment
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00657956
Start Date
April 1 2008
End Date
January 1 2013
Last Update
March 31 2014
Active Locations (1)
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1
Halifax Infirmary
Halifax, Nova Scotia, Canada, B3H 3A7