Total Knee Arthroplasty (TKA) Cemented Versus Cementless

Hospices Civils de Lyon130 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

130

Conditions

Osteoarthritis, Knee

Interventions

cement Palacos R40 and LV40DEVICE

Eligibility

Sex: ALLMin age: 50 YearsMax age: 90 Years

Medical Language ↔ Plain English

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)

Locations (1)

Hôpital de la Croix-Rousse

Lyon, France

Outcomes

Primary Outcomes

IKS (International Knee Society) score at 12 months

Secondary Outcomes

Analysis of femoral radiolucent line at the X-rays (profile and anterior-posterior [AP] view) at 12 months

Data from ClinicalTrials.gov

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