ROSA® Hip System THA PMCF

Status Not yet recruiting

Clinical Trial Summary

This study is a Prospective, Multicenter, Single-Arm, Cohort post-market study to evaluate the accuracy of acetabular implant position using the robotic-arm surgical assistant (ROSA® Hip System).

Clinical Trial Description

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 assess the accuracy of acetabular implant position by evaluating the percentage of participants who are within the range of the Callanan safe zones for Acetabular Inclination (30 - 45 degrees). A patient is considered a success if their intra-operative and/or post-operative full pelvis fluoroscopic or radiographic images show the postoperative acetabular inclination to be within this safe zone range. 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, 3-months, 1-year, and 2-years. Enrollment for the study is anticipated to last approximately 18 months. Allowing for 24 months of follow-up, the total estimated study time to final-patient final-visit will be approximately 42 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05497206
Study type	Interventional
Source	Zimmer Biomet
Contact	Megan McKinnie
Phone	1 (919) 381-7091
Email	megan.mckinnie@zimmerbiomet.com
Status	Not yet recruiting
Phase	N/A
Start date	June 2024
Completion date	December 2026

View Details

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