Do We Need Computer Assistance To Improve the Survival of Primary Total Knee Arthroplasty. A Minimum Ten Years Follow-up
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Ewha Womans University
- Enrollment
- 520
- Locations
- 2
- Primary Endpoint
- Improvement in Knee Society Knee Score
Study Overview
Brief Summary
The investigators asked: (1) Do computer-assisted total knee arthroplasty (TKAs) provide better alignment and clinical function? (2) Do computer-assisted TKAs provide better survivorship of implants and less complication? and (3) Do correction of the mechanical axis of the lower limb to within 3° of neutral is a prognostic marker for late revision surgery due to aseptic loosening?
Detailed Description
Computer-assisted total knee arthroplasty (TKA) is reported to improve the overall accuracy of positioning of the femoral and tibia components. However, an acceptable target for alignment remains a matter for debate. A mechanical axis within 3° of neutral axis has been used as the primary outcome measure in many clinical trials comparing computer-assisted- and conventional TKA. However, the evidence supporting this arbitrary value is unreliable because previous reports are limited by their small sample size, inadequate radiographs, short follow-up and lack of clarity when defining a margin of accuracy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 49 Years to 88 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •End stage osteoarthritis of the knee joint who require total knee arthroplasty with bilateral lesions.
Exclusion Criteria
- •Inflammatory disease
- •patient with other Lower extremity disease which may affect functional outcome
- •Neurologic disease effecting patients lower extremity
- •Revision surgery
- •Patient not medically cleared for bilateral surgery
Arms & Interventions
Non-Computer Assistance TKA
Non-Computer Assistance TKA
Intervention: Non-Computer Assistance TKA (Procedure)
Computer Assistance TKA
Computer Assistance TKA
Intervention: Computer Assistance TKA (Procedure)
Outcomes
Primary Outcomes
Improvement in Knee Society Knee Score
Time Frame: 10.5 years
change in knee score will be compared with initial score, until follow up of 10.5 years
Secondary Outcomes
- Improvement in the range of motion(10.5 years)
Investigators
Young Hoo Kim
Professor and Director
Ewha Womans University