At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 100 enrolled
Drug / intervention
Total Knee Arthroplastydevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Outcome With Attention to Functional Results One Year After Fixed or Mobile Bearing Total Knee Replacement in a Randomized Controlled Trial
In Brief
A Phase 4 clinical trial evaluating Total Knee Arthroplasty for Osteoarthritis and 2 related conditions. Completed, enrolled 100 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany
Collaborators--
Timeline
Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2004
Primary CompletionJun 2007
Study CompletionJul 2008
First PostedJan 2009
TodayJul 2026
First PostedJan 14, 2009
Enrollment StartMar 1, 2004
Primary CompletionJun 1, 2007
Study CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 17.5 years ago
Interventions
Total Knee Arthroplastydevice
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.