TerminatedNot Applicable

ATTUNE Cementless FB Tibial Base Clinical Study

Stopped: Study was unfunded.

United States80 participantsStarted 2022-05-09

Plain-language summary

This is a prospective, multi-center, non-randomized, single arm observational study. The primary objective of this clinical investigation is to evaluate functional responder rates with an objective performance criteria (OPC) of 85% as measured by the KOOS questionnaire for the first 225 tibia (CR FB and PS FB combined) implanted with the ATTUNE Cementless FB tray (primary and revision procedures) and will be analyzed when these patients have passed the 1 year preferred post-op window.

Who can participate

Age range22 Years – 80 Years

SexALL

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Inclusion criteria

✓. Subject is male or female and between the ages of 22 and 80 years at the time of consent, inclusive.
✓. Subject has a severely painful knee and/or impaired knee function resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant provided that adequate bone is present.
✓. Subject that is willing to give voluntary, written informed consent to participate in this clinical investigation and authorize the transfer of his/her information to the Sponsor.
✓. Subject is currently not bedridden.
✓. Subject, in the opinion of the Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedures and follow-up visits and co-operate with investigational procedures.
✓. Subject is able to read and comprehend the Informed Consent Document as well as complete the required PROMs in either English or one of the available translations.

What they're measuring

One Year Functional Responder Rate of First 225 Subjects

Timeframe: through study completion, up to 10 months

Trial details

NCT IDNCT04630262

SponsorDePuy Orthopaedics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-03-31

Results submitted2024-01-25

View on ClinicalTrials.gov More Osteoarthritis of the Knee trials