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Total Knee Arthroplasty (TKA) Cemented Versus Cementless

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ClinicalTrials.gov Identifier: NCT00132587
Recruitment Status : Completed
First Posted : August 22, 2005
Last Update Posted : July 4, 2008
Information provided by:
Hospices Civils de Lyon

Brief Summary:

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 or disease Intervention/treatment
Osteoarthritis, Knee Device: cement Palacos R40 and LV40

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Prospective Randomized Study of 130 Total Knee Arthroplasty With Cemented Femoral Implant Versus Cementless
Study Start Date : March 2004
Primary Completion Date : December 2006
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Primary Outcome Measures :
  1. IKS (International Knee Society) score at 12 months

Secondary Outcome Measures :
  1. Analysis of femoral radiolucent line at the X-rays (profile and anterior-posterior [AP] view) at 12 months

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00132587

Hôpital de la Croix-Rousse
Lyon, France, 69317
Sponsors and Collaborators
Hospices Civils de Lyon
Principal Investigator: Philippe NEYRET, MD Hospices Civils de Lyon

Responsible Party: Philippe Neyret, Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00132587     History of Changes
Other Study ID Numbers: 2003.313
First Posted: August 22, 2005    Key Record Dates
Last Update Posted: July 4, 2008
Last Verified: June 2008

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

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Polymethyl Methacrylate
Vasodilator Agents
Antimutagenic Agents
Protective Agents
Physiological Effects of Drugs