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Total Knee Arthroplasty (TKA) Cemented Versus Cementless

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status

Completed

Conditions

Osteoarthritis, Knee

Treatments

Device: cement Palacos R40 and LV40

Study type

Interventional

Funder types

Other

Identifiers

NCT00132587
2003.313

Details and patient eligibility

About

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.

Sex

All

Ages

50 to 90 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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