NCT02924961|Terminated
Study Stopped
Mobile-bearing insert dislocation
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Mobile-bearing insert dislocation
Sponsor study identifier
interventional
48
1 country
1
Study Start
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2011
Actual (reported)Study Completion
February 2016
Actual (reported)The goal of this study is to compare the fixed bearing (FB) Triathlon knee (Stryker, USA) and the mobile bearing (MB) Triathlon knee (Stryker, USA) and study the effect of implant design on kinematics and micromotion. During two tasks the kinematics measured with fluoroscopy (kinematics and movement of the polyethylene bearing). Roentgen Stereophotogrammetric Analysis (RSA) will be used to evaluate micromotion between prosthesis and the bone for the MB and FB Triathlon knee.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
July 2011
Actual (reported)February 2016
Actual (reported)September 21, 2016
Actual (reported)October 5, 2016
Actual (reported)Migration, measured by means of RSA on the first 20 patients (fluoroscopy subset)
Migration (MTPM in mm) of the prosthesis with respect to the host bone measured by means of roentgen stereophotogrammetric analysis (RSA)
First or second day postoperatively, 6 months, 1 year
Migration, measured by means of RSA
First or second day postoperatively, 6 months, 1 year and annually thereafter up to 20 years
Assessment of the knee flexion range by means of fluoroscopy during step-up motions
6 months and 13 months postoperatively
Assessment of the axial rotation range of femoral component by means of fluoroscopy during step-up motions
6 months and 13 months postoperatively
Assessment of the knee flexion range by means of fluoroscopy during lunge motions
6 months and 13 months postoperatively
Assessment of the axial rotation range of femoral component by means of fluoroscopy during lunge motions
6 months and 13 months postoperatively
Primary total knee replacement with cemented Triathlon posterior stabilized mobile-bearing
Primary total knee replacement with cemented Triathlon posterior stabilized fixed-bearing
Department of Orthopaedics, Leiden University Medical Center
Leiden, 2300RC, Netherlands
R.G.H.H. Nelissen, MD, PhD
Head of Department of Orthopaedics, Leiden University Medical Center
48 participants (actual enrollment reported by the registry).
First Submitted
September 21, 2016
First Posted
October 5, 2016
Study Start
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
Economic-demographic Assessment of the Aseptic Mobilization of Knee Prostheses Through the RIPO Registry and Radiographic Analysis of the Case Series From the II Clinic of IOR
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Primary Completion
July 2011
Actual (reported)Study Completion
February 2016
Actual (reported)Last Updated
March 7, 2018
Record last verified: 2018-03
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Source: ClinicalTrials.gov.
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