A Randomized Controlled Trial for Partial Knee Arthroplasty

NCT05037734 | Withdrawn FDA Device

• 1 other identifier: CMU2020-28CA
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Accuracy of implant position

  To compare and evaluate the accuracy of implant position of robotic-arm surgical assistant (ROSA® Partial Knee System) with that of conventional instrumentation (Traditional UKA). Accuracy of the Implemented Plan will be evaluated by assessing Implant alignment post-operatively for participants enrolled for both Conventional Instrumentation and the ROSA® Partial Knee System.

  6 Weeks

Secondary Outcomes (7)

• Evaluation of Patient safety

  24 months

• Evaluation of range of motion

  24 months

• Evaluation of Instability

  24 months

• Patient Reported Outcome Measure (Oxford Knee Score)

  24 months

• Patient Reported Outcome Measure (KOOS-12)

  24 months

Study Arms (2)

Robotic-Assisted UKA

ACTIVE COMPARATOR

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

Device: Persona Partial Knee System

Traditional/Conventional UKA

ACTIVE COMPARATOR

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

Device: Persona Partial Knee System

Interventions

Persona Partial Knee System DEVICE

Unicompartmental Knee Replacement

Robotic-Assisted UKA; Traditional/Conventional UKA

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

Mississippi Sports Medicine and Orthopaedic Center

Jackson, Mississippi, 39202, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Hillary Overholser

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participant will be randomized into one of the two available study arms, and will be blinded from treatment until surgery has occurred.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: September 8, 2021
• Study Start: June 1, 2023
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: June 5, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)