NCT02355652
Withdrawn
Phase 4
Comparison of Two Surgical Strategies of Total Knee Arthroplasty : Cemented Versus Uncemented HLS Knee-Tec Prosthesis System. A Prospective Randomized Study.
ConditionsTotal Knee Arthroplasty
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Total Knee Arthroplasty
- Sponsor
- Hospices Civils de Lyon
- Locations
- 1
- Primary Endpoint
- IKS 2011 Score measuring the clinical results of TKA
- Status
- Withdrawn
- Last Updated
- 9 years ago
Overview
Brief Summary
The goal of this prospective randomized double-blind study is to compare clinical and radiological results of cemented and uncemented total knee arthroplasty (TKA).
Two hundred and fifty patients will be randomized in two groups : cemented TKA and uncemented TKA.
The primary outcome is the comparison of the International Knee Society (IKS) Score revised in 2011 at one year postoperative.
The second outcome is the comparison of standard one year-postoperative x-rays looking for signs of loosening.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Knee osteoarthritis
- •Need for a total knee arthroplasty
Exclusion Criteria
- •Age \< 50 or \> 80
- •Need for a different procedure than a TKA
- •Preoperative knee flexion \< 90°
- •Need for a TKA associated with a combined femoral or tibial osteotomy
- •Knee already operated except for arthroscopy
- •Mediocre bone quality
Outcomes
Primary Outcomes
IKS 2011 Score measuring the clinical results of TKA
Time Frame: One year postoperative
IKS 2011 Score will be assessed for each patients and the mean IKS Score will be compared between both arms
Secondary Outcomes
- Number of patients in each arm with radiological loosening signs of the TKA components(One year postoperative)
Study Sites (1)
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