Total Knee Arthroplasty (TKA) Cemented Versus Cementless - Full Text View

Sponsored by:	Hospices Civils de Lyon
Information provided by:	Hospices Civils de Lyon
ClinicalTrials.gov Identifier:	NCT00132587

Purpose

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.

Condition	Intervention
Osteoarthritis, Knee	Device: cement Palacos R40 and LV40

MedlinePlus related topics: Knee Replacement Osteoarthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment
Official Title:	Prospective Randomized Study of 130 Total Knee Arthroplasty With Cemented Femoral Implant Versus Cementless

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:

IKS (International Knee Society) score at 12 months

Secondary Outcome Measures:

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

Estimated Enrollment:	130
Study Start Date:	March 2004
Study Completion Date:	March 2007
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	50 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00132587

Locations

France
Hôpital de la Croix-Rousse
Lyon, France, 69317

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator:

Philippe NEYRET, MD

Hospices Civils de Lyon

More Information

Responsible Party:	Hospices Civils de Lyon ( Philippe Neyret )
Study ID Numbers:	2003.313
Study First Received:	August 19, 2005
Last Updated:	June 30, 2008
ClinicalTrials.gov Identifier:	NCT00132587
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Hospices Civils de Lyon:

Knee arthroplasty
Femoral loosening
Total Knee Arthroplasty

Study placed in the following topic categories:

Polymethyl Methacrylate
Osteoarthritis, Knee
Musculoskeletal Diseases
Osteoarthritis

Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on January 14, 2009