Status:
COMPLETED
Comparison of Rotating vs. Fixed Platform of the COLUMBUS Knee Prosthesis
Lead Sponsor:
Aesculap AG
Conditions:
Osteoarthritis
Rheumatoid Arthritis
Eligibility:
All Genders
40-90 years
Phase:
PHASE4
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 postoperativ...
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...
Eligibility Criteria
Inclusion
- Indication for elective TKA
- agreement to participate in this study
- Patient age between 40 and 90 years
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00822640
Start Date
March 1 2004
End Date
July 1 2008
Last Update
May 14 2013
Active Locations (1)
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1
Frank Lampe, MD
Hamburg, Germany, 22081