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Clinical Trials/NCT00132587
NCT00132587
Completed
Not Applicable

Prospective Randomized Study of 130 Total Knee Arthroplasty With Cemented Femoral Implant Versus Cementless

Hospices Civils de Lyon1 site in 1 country130 target enrollmentMarch 2004

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis, Knee
Sponsor
Hospices Civils de Lyon
Enrollment
130
Locations
1
Primary Endpoint
IKS (International Knee Society) score at 12 months
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2004
End Date
March 2007
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility 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)

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

Study Sites (1)

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