Clinical Trial: TKA Cemented Versus Cementless

This study is currently recruiting patients.
Verified by Hospices Civils de Lyon July 2005

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 femoral implant with or without cement.

130 patients will be operate and include with 2 groups, the first with TKA all cemented and the second one with TKA with cementless femoral implant The study criteria is the IKS (international knee society) score and the analyse of a radiolucent line at the femur.

Patients will be review at 2, 6 and 12 months.

Condition Intervention
Knee Osteoarthritis
 Device: cement Palacos R40 and LV40

MedlinePlus related topics:  Osteoarthritis

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: 
Primary Outcomes: IKS score (International Knee Society) at 12 months
Secondary Outcomes: Analysis of femoral radiolucent line at the X-rays (profile and AP view) at 12 months
Expected Total Enrollment:  130

Study start: March 2004

Eligibility

Ages Eligible for Study:  50 Years   -   90 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • osteoarthritis (medial or/and lateral femoro-tibial arthritis or/and patello-femoral arthritis)
  • indication of surgical treatment by Total Knee Arthroplasty
  • age between 50 and 90 ys
  • acceptation and signature to participate

Exclusion Criteria:

  • Rheumatoïd or other inflammatory arthritis
  • Association with other surgical procedure (osteotomy)
  • Range of motion inferior to 90°
  • Previous knee surgery (except arthroscopy)

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00132587

Elvire SERVIEN, MD      33 472 071 794    elvire.servien@chu-lyon.fr

France
      Elvire SERVIEN, Lyon,  69300,  France; Recruiting
Elvire SERVIEN, MD  33 472 071 794    elvire.servien@chu-lyon.fr 
Philippe NEYRET, MD,  Principal Investigator

Study chairs or principal investigators

Philippe NEYRET, MD,  Principal Investigator,  Hospices Civils de Lyon   

More Information

Study ID Numbers:  2003-313
Last Updated:  August 19, 2005
Record first received:  August 19, 2005
ClinicalTrials.gov Identifier:  NCT00132587
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-08-23

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