Cemented Versus Uncemented Total Knee Arthroplasty : a Prospective Randomized Study
NCT ID: NCT02355652
Last Updated: 2017-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2015-01-31
2017-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cemented TKA
Surgical total knee replacement using cemented components
Each patient of this arm will go under a surgical procedure of total knee replacement (or total knee arthroplasty) using cemented femoral and tibial prosthetic components.
Uncemented TKA
Surgical total knee replacement using uncemented components
Each patient of this arm will go under a surgical procedure of total knee replacement (or total knee arthroplasty) using uncemented femoral and tibial prosthetic components.
Interventions
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Surgical total knee replacement using cemented components
Each patient of this arm will go under a surgical procedure of total knee replacement (or total knee arthroplasty) using cemented femoral and tibial prosthetic components.
Surgical total knee replacement using uncemented components
Each patient of this arm will go under a surgical procedure of total knee replacement (or total knee arthroplasty) using uncemented femoral and tibial prosthetic components.
Eligibility Criteria
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Inclusion Criteria
* Need for a total knee arthroplasty
Exclusion Criteria
* 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
50 Years
80 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Philippe NEYRET, Pr
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon
Locations
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Hôpital de la Croix-Rousse
Lyon, , France
Countries
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Related Links
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Related Info
Other Identifiers
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2014.883
Identifier Type: -
Identifier Source: org_study_id
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