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ClinicalTrials.gov ID

NCT07080671

Lead Sponsor

JointMedica Inc.OTHER

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

105Estimated

Last Update Posted

Jul 23, 2025Actual

Start Date

Jul 25, 2025Estimated

Primary Completion Date

Oct 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

Official Title

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

Brief 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.

Detailed Description

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.

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

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

Eligibility Criteria

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

Exclusion Criteria:

• There is no exclusion criteria for this study

Observational Model

Case-Only

Time Perspective

Other

Lead Sponsor

JointMedica Inc.OTHER

jimmackenzie1@me.com(403) 910-4585

info@hughblackley.co.nz+649 522 2980