Cemented Versus Uncemented Total Knee Arthroplasty : a Prospective Randomized Study

Phase 4

Withdrawn

• Conditions: Total Knee Arthroplasty
• Interventions: Device: Surgical total knee replacement using uncemented components; Device: Surgical total knee replacement using cemented components

• Registration Number: NCT02355652
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-26
• Study First Submitted QC: 2015-02-03
• Study First Posted: 2015-02-04
• Status Verified: 2017-01
• Primary Completion: 2017-01
• Last Update Submitted: 2017-01-05
• Last Update Posted: 2017-01-06
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Knee osteoarthritis
• Need for a total knee arthroplasty

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Uncemented TKA	Surgical total knee replacement using uncemented components	-
Cemented TKA	Surgical total knee replacement using cemented components	-

Primary Outcome Measures

Name	Time	Method
IKS 2011 Score measuring the clinical results of TKA	One year postoperative	IKS 2011 Score will be assessed for each patients and the mean IKS Score will be compared between both arms

Secondary Outcome Measures

Name	Time	Method
Number of patients in each arm with radiological loosening signs of the TKA components	One year postoperative	At one year postoperative, each patient will go under standard radiological exam seeking for signs of loosening of the prosthetic components. The number of patients presenting radiological signs of loosening will be compared between both arms.

Trial Locations

Locations (1)

Hôpital de la Croix-Rousse; 🇫🇷 Lyon, France