A Randomized Controlled Trial for Partial Knee Arthroplasty
Withdrawn before enrolling · Not applicable
Conditions studied: Degenerative Joint Disease of Knee, Osteoarthritis, Traumatic Arthritis, Varus Deformity, Knee Pain Chronic
In brief
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.
Key facts
- Study ID
- NCT05037734
- Run by
- Zimmer Biomet
- People needed
- 0
- Starts
- 2023-06-01
- Expected to finish
- 2030-12-01
- Last updated by the study team
- 2023-06-05
Who can join
Age: any. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
- Patient has a condition which would, in the judgement of the investigator, place the patient at undue risk or interfere with the conduct of the study.
Where it is running
- Mississippi Sports Medicine and Orthopaedic Center — Jackson, Mississippi, United States
Full record on ClinicalTrials.gov
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