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Cemented Versus Uncemented Total Knee Arthroplasty : a Prospective Randomized Study

NCT02355652 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2017-01-06

No results posted yet for this study

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.

Conditions

  • Total Knee Arthroplasty

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Philippe NEYRET, Pr · Hospices Civils de Lyon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2017-01-31
Completion
2017-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02355652 on ClinicalTrials.gov