Status:
COMPLETED
Application of Radiostereometric Analysis (RSA) to Triathlon Knee Components Inserted Using the OtisMed Custom-fit Total Knee Replacement System
Lead Sponsor:
Dalhousie University
Conditions:
Osteoarthritis
Eligibility:
All Genders
21-80 years
Phase:
NA
Brief Summary
The OtisMed Custom-fit system for total knee replacements replaces conventional surgical techniques for templating and intra-operative instrumentation with a preoperative virtual surgery process that ...
Detailed Description
Knee and hip arthroplasty are profoundly successful operative interventions, however, some joint replacements do fail and the life expectancy of a knee or hip arthroplasty is finite. This fact has lar...
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
- Pregnancy
- 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 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01262430
Start Date
April 1 2011
End Date
December 1 2019
Last Update
August 21 2020
Active Locations (1)
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1
Capital District Health Authority
Halifax, Nova Scotia, Canada, B3H 4A7