NCT05037734

A Randomized Controlled Trial for Partial Knee Arthroplasty

A Post-Market, Multicenter, Randomized Controlled Trial of the ROSA® Partial Knee System for Unicompartmental Knee Arthroplasty

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	Persona Partial Knee System	Unicompartmental Knee Replacement

Timeline

• Start date: 2023-06-01
• Primary completion: 2030-06-01
• Completion: 2030-12-01
• First posted: 2021-09-08
• Last updated: 2023-06-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study