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

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ClinicalTrials.gov Identifier: NCT00822640
Recruitment Status : Completed
First Posted : January 14, 2009
Last Update Posted : May 14, 2013
Sponsor:
Information provided by:
Aesculap AG

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Rheumatoid Arthritis Post-traumatic; Arthrosis Device: Total Knee Arthroplasty Phase 4

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Outcome With Attention to Functional Results One Year After Fixed or Mobile Bearing Total Knee Replacement in a Randomized Controlled Trial
Study Start Date : March 2004
Actual Primary Completion Date : June 2007
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Columbus Knee Prosthesis with rotating Platform
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
Active Comparator: 2
Columbus Knee Prosthesis with fixed platform
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



Primary Outcome Measures :
  1. Knee Society Score [ Time Frame: 12 Months ]

Secondary Outcome Measures :
  1. Oxford Score [ Time Frame: 12 ]
  2. Range of Motion [ Time Frame: 12 Months ]


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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00822640


Locations
Germany
Frank Lampe, MD
Hamburg, Germany, 22081
Sponsors and Collaborators
Aesculap AG
Investigators
Principal Investigator: Frank Lampe, MD Schön Kliniken Klinikum Eilbek

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. med. Frank Lampe, Schön Kliniken, Klinikum Eilbek
ClinicalTrials.gov Identifier: NCT00822640     History of Changes
Other Study ID Numbers: AAG-G-H-0301
First Posted: January 14, 2009    Key Record Dates
Last Update Posted: May 14, 2013
Last Verified: May 2013

Keywords provided by Aesculap AG:
Prosthesis Design
Range of Motion, Articular
Arthroplasty, Replacement, Knee

Additional relevant MeSH terms:
Osteoarthritis
Arthritis, Rheumatoid
Joint Diseases
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases