Comparison of Pivotal Medial Polyethylene Versus Ultra-congruent in Total Knee Arthroplasty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity Hospital, Clermont-Ferrand
About this trial
The aim of this study is to compare the forgotten joint score for the medial pivot polyethylene and ultra-congruent polyethylene which are used in total prosthetic replacement of the knee
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects 18 to 90 years of age, eligible for a primary total knee replacement for gonarthrosis
Competent subjects able to give informed consent to participate in the research
Affiliation to the social security system
Disqualifiers
Infection history of the knee to be replaced
Deformity greater than 15 degrees
Any surgical and/or anesthetic contraindication, or any condition deemed by the investigator to be incompatible with the research.
Any contraindication mentioned in the instructions for use of the medical device
Trial design
Design model
Parallel
Treatments tested in this trial
total knee arthroplasty with medial pivot polyethylene
Devicetotal knee arthroplasty with medial pivot polyethylene
total knee arthroplasty with ultra-congruent polyethylene
Devicetotal knee arthroplasty with ultra-congruent polyethylene
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: medial pivot polyethyleneActive comparator 1 intervention
Group B: ultra-congruent polyethyleneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
evaluation of the forgotten joint score (FJS12)
Forgotten knee score at 6 weeks (FJS-12, evaluated out of 100), which allows the analysis of quality of life specifically in relation to knee pathologies
Time frame
Day 452
evaluation of the forgotten joint score (FJS12)
Forgotten knee score at 6 weeks (FJS-12, evaluated out of 100), which allows the analysis of quality of life specifically in relation to knee pathologies
Time frame
Month 12Secondary outcomes
1
knee joint mobility
Measurement of mobility in degrees (scale from 0 to 10)
Time frame
Day -12
knee joint mobility
Measurement of mobility in degrees (scale from 0 to 10)
Time frame
Day 453
knee joint mobility
Measurement of mobility in degrees (scale from 0 to 10)
Time frame
month 124
pain assessment
assessment with a numeric pain rating scale ranging from 0 (none) to 10 (severe pain)
Time frame
Day -1Sponsors and contacts
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Source ClinicalTrials.gov