Should my New Knee Rotate?
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|ClinicalTrials.gov Identifier: NCT02892838|
Recruitment Status : Completed
First Posted : September 8, 2016
Last Update Posted : April 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Arthritis of the Knee Joint||Device: mobile bearing knee system for total knee arthroplasty Device: fixed bearing total knee prosthesis||Phase 4|
This is a prospective, comparative, randomised, open-label, single center, multiple surgeons clinical study. The Scorpio PS Superflex and the Scorpio PS mobile bearing are to be implanted for evaluation in this study. Patients will be randomised to one of two equal sized groups. In the first group patients will be treated with the Scorpio PS Superflex, whilst in the second group patients will be treated with the Scorpio PS mobile bearing implant.
Evaluations consist of the KSS score, Chair rise and stair climb tests, radiology assessments, patient questionnaires, at multiple timepoints: pre-operative, 6 weeks, 3 months, 6 months 1 year, 2 years and 5 years post-operatively.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Should my New Knee Rotate? A Randomised, Controlled Clinical Trial to Compare Fixed and Mobile Bearing Total Knee Arthroplasties Using the SCORPIO PS and SCORPIO+ PS Knee Systems|
|Study Start Date :||September 2003|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||December 2011|
Experimental: mobile bearing knee prosthesis
use of the Scorpio mobile bearing knee system for total knee arthroplasty
Device: mobile bearing knee system for total knee arthroplasty
Active Comparator: fixed bearing
use of the Scorpio fixed bearing knee system for total knee arthoplasty
Device: fixed bearing total knee prosthesis
- Anterior knee pain during stair rise [ Time Frame: 5 years ]Anterior knee pain using VAS during stair rise at different follow up moments until 5 years after surgery
- Anterior knee pain during stair climb [ Time Frame: 5 years ]Anterior knee pain using VAS during stair climb at different FU moments
- passive and active Range of motion [ Time Frame: 5 years ]measuring passive and active range of motion (flexion / extension) using a goniometer at different FU moments
- patella compression pain [ Time Frame: 5 years ]patella compression pain at physical examination at different FU moments defined as yes of no when putting mild pressure on the patella
- patient satisfaction [ Time Frame: 5 years ]measuring patient satisfaction using the RAND-36 questionnaire at different FU moments
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): NCT02892838
|Principal Investigator:||Peter Feczko, MD||orthopedic surgeon MUMC Maastricht|