WithdrawnNot Applicable

A Randomized Controlled Trial for Partial Knee Arthroplasty

Stopped: Relaunch at later date with updated product.

United States0Started 2023-06

Plain-language summary

This is a prospective, multi-center, two-arm, randomized, controlled post-market study to evaluate and compare the clinical accuracy of component placement in robotic-assisted UKA and that of traditional methods.

Who can participate

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

✓. Patient meets the approved indications for use in accordance with product labeling for both the Persona Partial Knee System and the ROSA® Partial Knee System.
✓. Body mass index ≤40 kg/m2
✓. Patient is of legal age and skeletally mature
✓. Patient is willing and able to provide informed consent.
✓. Patient is willing to be randomized into one of two study groups of UKA performed using ROSA® and UKA using Conventional Instrumentation
✓. Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol.
✓. Patient qualifies for primary UKA based on investigator's clinical judgement and has an intact anterior cruciate ligament.
✓. Independent of study participation, patient is a candidate for the commercially available Persona Partial Knee System.

Exclusion criteria

✕. Independent of study participation, patient meets any of the contraindications for use in accordance with product labeling of the Persona Partial Knee System and/or the ROSA® Partial Knee System.
✕. Orthopaedic procedure or pain management study of any joint within the last or next 6 months; furthermore, bilateral enrollment is excluded in this study.
✕. Prior ACL Repair
✕. Moderate to severe patello-femoral arthritis, that in the opinion of the investigator, would require patella-femoral arthroplasty.
✕. Patient is unwilling to sign the Informed Consent.
✕. Would, in the investigator's opinion, be unwilling or unable to comply with the postoperative care instructions or study follow-up schedule.
✕. Patient is considered a member of a protected/vulnerable population (Pregnant, prisoner, mentally incompetent, etc.).
✕. Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation.

What they're measuring

Accuracy of implant position

Timeframe: 6 Weeks

Trial details

NCT IDNCT05037734

SponsorZimmer Biomet

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2030-06

View on ClinicalTrials.gov More Degenerative Joint Disease of Knee trials