Status:
COMPLETED
Roentgen Stereophotogrammetric Analysis (RSA) Trial Comparing Trabecular Metal Monoblock and Modular Tibial Components
Lead Sponsor:
Dalhousie University
Collaborating Sponsors:
Zimmer Biomet
Conditions:
Osteoarthritis
Eligibility:
All Genders
21-80 years
Phase:
PHASE4
Brief Summary
Total knee replacement is an effective option for treating chronic knee conditions that cause pain and functional impairment. Significant improvements in quality of life, as measured by both disease s...
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 :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2019
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01180595
Start Date
February 1 2011
End Date
September 1 2019
Last Update
August 19 2021
Active Locations (1)
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1
Halifax Infirmary
Halifax, Nova Scotia, Canada, B3H 3A7