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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014