Cemented Versus Uncemented Total Knee Arthroplasty : a Prospective Randomized Study

NCT ID: NCT02355652

Last Updated: 2017-01-06

Study Results

Results pending

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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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-03-31

Brief Summary

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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

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Conditions

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Total Knee Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cemented TKA

Group Type ACTIVE_COMPARATOR

Surgical total knee replacement using cemented components

Intervention Type DEVICE

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

Group Type ACTIVE_COMPARATOR

Surgical total knee replacement using uncemented components

Intervention Type DEVICE

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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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France

Related Links

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Other Identifiers

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2014.883

Identifier Type: -

Identifier Source: org_study_id

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