Clinical Trial

Clinical and Radiographic Outcomes of the JointMedica Polymotion Resurfacing (PHR) Device

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Summary
The goal of this observational study is to generate Real World Evidence (RWE) on the device performance of the Polymotion Hip Resurfacing (PHR) system and its use in patients who have been implanted with the device for the treatment of hip osteoarthritis. This study will assess the following endpoints: * The survivorship of the Acetabular Cup (Kaplan-Meier estimate) through 2 years of follow-up. * Radiographic success of the implanted cups, through quantitative motion analysis to assess migration of the acetabular cups. * Absence of subsequent surgical intervention at the acetabulum of there operated hip. * Absence of serious, device-related adverse events. * Patient reported outcomes through Harris Hip Score and SUSHI - UCLA Hip Score questionnaires.
Trial Details
NCT Number NCT07080671
Lead Sponsor JointMedica Inc.
Conditions Healthy, Real World Data, Safety and Effectiveness, Patient Reported Outcome (PRO)
Enrollment 105 participants
Start Date 2025-07-25
Primary Completion 2026-10-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-07-23