Clinical and Radiographic Outcomes of the JointMedica Polymotion Resurfacing (PHR) Device
NCT07080671 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 105
Last updated 2025-07-23
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.
Conditions
- Healthy
- Real World Data
- Safety and Effectiveness
- Patient Reported Outcome (PRO)
Sponsors & Collaborators
-
JointMedica Inc.
lead OTHER
Principal Investigators
-
Ronan Treacy
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-07-25
- Primary Completion
- 2026-10-31
- Completion
- 2026-12-31
Countries
- Australia
- Canada
- New Zealand
Study Locations
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