Total Knee Arthroplasty (TKA) Cemented Versus Cementless

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

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2007-03-31

Brief Summary

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The aim of the study is to analyse and to compare the quality of fixation of a femoral implant with or without cement.

One hundred thirty patients will be operated on and included with 2 groups, the first one with TKA all cemented and the second one with TKA with a cementless femoral implant. The study criteria include the IKS (International Knee Society) score and the analysis of a radiolucent line at the femur.

Patients will be reviewed at 2, 6 and 12 months.

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Detailed Description

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Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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cement Palacos R40 and LV40

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Osteoarthritis (medial and/or lateral femoro-tibial arthritis and/or patellofemoral arthritis)
* Indication of surgical treatment by total knee arthroplasty
* Age between 50 and 90 years
* Acceptance and signature to participate

Exclusion Criteria

* Rheumatoid or other inflammatory arthritis
* Association with other surgical procedure (osteotomy)
* Range of motion inferior to 90°
* Previous knee surgery (except arthroscopy)

Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No