RecruitingNot Applicable

Persona Revision Knee System Outcomes

United States380 participantsStarted 2021-06-14

Plain-language summary

The study will evaluate the performance, clinical benefits and safety of the Persona Revision Knee System in patients who have received primary or revision total knee arthroplasty (TKA) treatment. This will be done using a multicenter, single-arm, consecutive series, retrospective cohort study with prospective follow-up.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Male or female of at least 18 years of age at the time of screening.
✓. Signed an institutional review board approved informed consent.
✓. Willingness and ability to comply with the study procedures and visit schedules and ability to understand and follow oral and written post-operative care instructions.
✓. Previous medical diagnosis/ history of at least one of the following conditions requiring treatment using the Persona Revision Knee System within a pre-specified study variant configuration (cohort), in accordance with the instructions for use (IFU):
✓. Rheumatoid arthritis, osteoarthritis, traumatic arthritis or polyarthritis
✓. Collagen disorders, and/or avascular necrosis of the femoral condyle
✓. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
✓. Moderate valgus, varus, or flexion deformities

Exclusion criteria

✕. An ulcer of the skin
✕. History of recurrent breakdown of the skin
✕. Use of steroids

What they're measuring

Knee Society Clinical Rating System objective knee score (KS-KS)

Timeframe: 2 years

Trial details

NCT IDNCT04821154

SponsorZimmer Biomet

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-12-31

Contact for this trial

Chelsea Smith

714-740-9438 chelsea.smith2@zimmerbiomet.com

View on ClinicalTrials.gov More Arthroplasty Complications trials