Evaluation of The Safety And Performance of The Freedom Total Knee® System With The PEEK-OPTIMA F… (NCT03224689) | Clinical Trial Compass
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Evaluation of The Safety And Performance of The Freedom Total Knee® System With The PEEK-OPTIMA Femoral Component
Belgium34 participantsStarted 2021-01-01
Plain-language summary
Prospective, multi-centre, non-comparative, post-market surveillance clinical study
Who can participate
Age range50 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
INCLUSION CRITERIA:
* Male and female subjects aged 50 years of age or older and less than 75 years of age (\>50 and \<75 years).
* Subjects who require a uni-lateral knee prosthesis and have been evaluated as appropriate candidates for a total knee arthroplasty by the Investigator.
* Subjects with a primary diagnosis of end-stage symptomatic primary knee osteoarthritis
* Subjects who, in the opinion of the Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
* Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
EXCLUSION CRITERIA:
* Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation.
* Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
* Subjects who have participated in a clinical study with an investigational product in the last 6 months.
* Subjects with other significant disabling problems from the muscular-skeletal system other than in the knees (i.e muscular dystrophy, polio, neuropathic joints).
* Subjects with a BMI of 32 or above.
* Subjects with a current or active history of malignancy, active or suspected infection, Paget…
What they're measuring
1
Knee Society Score (KSS)
Timeframe: Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months