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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-25

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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This is a retrospective and prospective study that will include a maximum of 70 patients who were implanted with the JointMedica Polymotion Hip Resurfacing (PHR) device in Canada, New Zealand and Australia.

Patients will be invited to consent to participate in this study, which will require their attendance of a follow-up standard of care visit to gather clinical data on the safety and performance of their index hip, undergo an x-ray imaging and complete two questionnaires to assess their functionality and outcomes.

Patient data will be entered into electronic data capture systems and x-rays will be submitted to a core imaging laboratory, MMI, for analysis to assess the state and position of their acetabular cup.

Conditions

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Healthy Real World Data Safety and Effectiveness Patient Reported Outcome (PRO)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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Patient Group

The patient group is the entire group of patients who have been implanted with the Polymotion Hip Resurfacing (PHR) system. This is the only group in the study, all patients will be assessed under the same criteria.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age 21 or above at the time of the surgery.
* Have had the Polymotion Hip Resurfacing (PHR) (implanted between September 2020 to January 2025
* Written informed consent given by subject

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes