A Randomized Controlled Trial for Partial Knee Arthroplasty

NCT ID: NCT05037734

Last Updated: 2023-06-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2030-12-31

Brief 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.

Detailed 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.

Conditions

Degenerative Joint Disease of Knee; Osteoarthritis; Traumatic Arthritis; Varus Deformity; Knee Pain Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Robotic-Assisted UKA

Randomized participant will receive UKA via the ROSA Partial Knee System.

Group Type: ACTIVE_COMPARATOR

Persona Partial Knee System

Intervention Type: DEVICE

Unicompartmental Knee Replacement

Traditional/Conventional UKA

Randomized participant will receive the UKA via Conventional/Traditional UKA Methods.

Group Type: ACTIVE_COMPARATOR

Persona Partial Knee System

Intervention Type: DEVICE

Unicompartmental Knee Replacement

Interventions

Persona Partial Knee System

Unicompartmental Knee Replacement

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Body mass index ≤40 kg/m2

3. Patient is of legal age and skeletally mature

4. Patient is willing and able to provide informed consent.

5. Patient is willing to be randomized into one of two study groups of UKA performed using ROSA® and UKA using Conventional Instrumentation

6. Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol.

7. Patient qualifies for primary UKA based on investigator's clinical judgement and has an intact anterior cruciate ligament.

8. Independent of study participation, patient is a candidate for the commercially available Persona Partial Knee System.

Exclusion Criteria

1. 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.

2. Orthopaedic procedure or pain management study of any joint within the last or next 6 months; furthermore, bilateral enrollment is excluded in this study.

3. Prior ACL Repair

4. Moderate to severe patello-femoral arthritis, that in the opinion of the investigator, would require patella-femoral arthroplasty.

5. Patient is unwilling to sign the Informed Consent.

6. Would, in the investigator's opinion, be unwilling or unable to comply with the postoperative care instructions or study follow-up schedule.

7. Patient is considered a member of a protected/vulnerable population (Pregnant, prisoner, mentally incompetent, etc.).

8. Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation.

9. 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hillary Overholser

Role: STUDY_DIRECTOR

Zimmer Biomet

Locations

Mississippi Sports Medicine and Orthopaedic Center

Jackson, Mississippi, United States

Countries

United States

Other Identifiers

CMU2020-28CA

Identifier Type: -

Identifier Source: org_study_id