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

This study has been completed.
Sponsor:
Information provided by:
Aesculap AG
ClinicalTrials.gov Identifier:
NCT00822640
First received: January 13, 2009
Last updated: May 13, 2013
Last verified: May 2013

January 13, 2009
May 13, 2013
March 2004
June 2007   (final data collection date for primary outcome measure)
Knee Society Score [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00822640 on ClinicalTrials.gov Archive Site
  • Oxford Score [ Time Frame: 12 ] [ Designated as safety issue: No ]
  • Range of Motion [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of Rotating vs. Fixed Platform of the COLUMBUS Knee Prosthesis
Clinical Outcome With Attention to Functional Results One Year After Fixed or Mobile Bearing Total Knee Replacement in a Randomized Controlled Trial

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Osteoarthritis
  • Rheumatoid Arthritis
  • Post-traumatic; Arthrosis
Device: Total Knee Arthroplasty
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 Name: Columbus Knee Prosthesis
  • Experimental: 1
    Columbus Knee Prosthesis with rotating Platform
    Intervention: Device: Total Knee Arthroplasty
  • Active Comparator: 2
    Columbus Knee Prosthesis with fixed platform
    Intervention: Device: Total Knee Arthroplasty

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
July 2008
June 2007   (final data collection date for primary outcome measure)

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
Both
40 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00822640
AAG-G-H-0301
No
Dr. med. Frank Lampe, Schön Kliniken, Klinikum Eilbek
Aesculap AG
Not Provided
Principal Investigator: Frank Lampe, MD Schön Kliniken Klinikum Eilbek
Aesculap AG
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP