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OpenTrials
Completed

NCT Number: NCT00822640

Comparison of Rotating vs. Fixed Platform of the COLUMBUS Knee Prosthesis

A population of 100 patients randomised to rotating and fixed PE inlays in the Columbus knee prosthesis received a navigated TKR. Knee Society Score as primary endpoint, Oxford Score, and postoperative ROM after one year will be compared.

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Key information

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Frank Lampe, MD

Hamburg, 22081, Germany

About this study

Mobile bearing tibial platform designs are advocated to improve functional results of total knee replacement (TKR), and to reduce wear in the longer term. This study investigates short term functional results with two patient groups who are systematically different in the fixed or mobile tibial bearing only.

Methods: 100 knees in 97 patients are stratified according to age and gender and randomized into two groups fixed bearing (FB) with 52 knees and mobile bearing (MB) with 48 knees. All receive the same posterior cruciate retaining implant but the tibial tray and bearing (B. Braun Aesculap Columbus CR and RP) by two experienced surgeons and follow an identical rehabilitation regime. Physical examinations are performed in a double-blinded manner before the operation and three, six and twelve months thereafter, using the Oxford and Knee Society scoring systems.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Indication for elective TKA
  • agreement to participate in this study
  • Patient age between 40 and 90 years

Exclusion criteria

  • Malalignment of the knee to be operated of more than 20° varus or 15° valgus
  • Former operations on the concerned knee (except diagnostic or therapeutic arthroscopy with only meniscus refixation or cartilage smoothing)
  • Joint replacement of another joint of the same leg
  • Infections in the operated joint during the follow-up period
  • Thromboses during the follow-up period
  • Preoperative classification according to ASA 4, 5 or 6

Treatment and study plan

Total knee arthroplasty

Device

All patients receive the same posterior cruciate retaining implant but the tibial tray and bearing (B. Braun Aesculap Columbus CR and RP) by two experienced surgeons and will follow an identical rehabilitation regime.

Other names: Columbus Knee Prosthesis

Primary outcomes

  1. Knee Society Score

    Time frame: 12 Months

Secondary outcomes

  1. Oxford Score

    Time frame: 12

  2. Range of Motion

    Time frame: 12 Months

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Registry information

Official study title

Clinical Outcome With Attention to Functional Results One Year After Fixed or Mobile Bearing Total Knee Replacement in a Randomized Controlled Trial

Important dates

Study start
2004
Primary completion
2007
Study completion
2008
First posted
Jan 14, 2009
Registry last updated
May 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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