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
  Purpose

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 Intervention Phase
Osteoarthritis
Rheumatoid Arthritis
Post-traumatic; Arthrosis
Device: Total Knee Arthroplasty
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Aesculap AG:

Primary Outcome Measures:
  • Knee Society Score [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Oxford Score [ Time Frame: 12 ] [ Designated as safety issue: No ]
  • Range of Motion [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: March 2004
Study Completion Date: July 2008
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00822640

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

Publications:

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
Study First Received: January 13, 2009
Last Updated: May 13, 2013
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on October 23, 2014