A Randomized Controlled Trial for Partial Knee Arthroplasty

Zimmer Biomet

Status

Withdrawn

Conditions

Degenerative Joint Disease of Knee

Traumatic Arthritis

Osteoarthritis

Knee Pain Chronic

Varus Deformity

Treatments

Device: Persona Partial Knee System

Study type

Interventional

Funder types

Industry

Identifiers

NCT05037734

CMU2020-28CA

Details and patient eligibility

About

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.

Full description

Sites will enroll participants into two separate arms for this study (rUKA and Conventional Instrumentation), following the assigned randomization. Consecutive patients who meet all of the inclusion criteria and none of the exclusion criteria will be eligible for participation in the study and will be pre-screened for participation in the informed consent process.

The primary objective of this study is to evaluate and compare the accuracy of the ROSA® Partial Knee System in regards to implant placement with that of traditional instrumentation. This will include the assessment of the planned vs. actual component positioning.

Secondary Objectives include the evaluation of safety and efficacy of this system and will include the assessment of common adverse events, physical exam findings, radiologic results and patient reported outcome measures.

Data collection will occur at the following intervals: Pre-operative, Operative, 6-weeks, 3-months, 1-year, and 2-years. Enrollment for the study is anticipated to last approximately 12-18 months. Allowing for 24 months of follow-up, the total estimated study time to final-patient final-visit will be approximately 42 months.

Sex

All

Volunteers

Accepts Healthy Volunteers

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.
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.