Total Knee Arthroplasty (TKA) Cemented Versus Cementless

This study has been completed.
Sponsor:
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00132587
First received: August 19, 2005
Last updated: June 30, 2008
Last verified: June 2008
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Prospective Randomized Study of 130 Total Knee Arthroplasty With Cemented Femoral Implant Versus Cementless

Resource links provided by NLM:


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

No publications provided

Responsible Party: Philippe Neyret, Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00132587     History of Changes
Other Study ID Numbers: 2003.313
Study First Received: August 19, 2005
Last Updated: June 30, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Knee arthroplasty
Femoral loosening
Total Knee Arthroplasty

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014