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

July 15, 2025 updated by: JointMedica Inc.

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
      • Adelaide, Australia
        • Mark Rickman
        • Contact:
        • Principal Investigator:
          • Mark Rickman
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2C 3G3
        • Gateway Surgery Centre
        • Contact:
        • Principal Investigator:
          • James MacKenzie
  • New Zealand
      • Auckland, New Zealand
        • Orthopaedic Specialist Centre
        • Contact:
        • Principal Investigator:
          • Hugh Blackley
        • Sub-Investigator:
          • Bill Farrington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Subjects that underwent hip arthroplasty procedure with the Polymotion Hip Resurfacing (PHR) System (V3.1 Cup design) between September 2020 to January 2025.

Subjects who have previously had the Polymotion Hip Resurfacing (PHR) System implanted at the sites will be contacted to give consent to participate in the collection of additional follow-up visits described within this protocol.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acetabular Cup Survivorship
Time Frame: From the primary implantation to end through to 24 months and 27months+ post operation.
The number of acetabular cups which are functional and not requiring additional surgical intervention following the primary implantation
From the primary implantation to end through to 24 months and 27months+ post operation.
Radiographic success
Time Frame: Between primary implantation surgery and post-operative review at 24-months and 27+ months.
Quantitative motion assessment of the acetabular cup at implantation and follow-up visit
Between primary implantation surgery and post-operative review at 24-months and 27+ months.
Serious Device-Related Adverse Events
Time Frame: From primary implantation to post-operative visit at 24-months or 27+months
Occurrence and severity of adverse events including necessitation of secondary surgical intervention.
From primary implantation to post-operative visit at 24-months or 27+months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JointMedica Inc.

Investigators

  • Principal Investigator: Ronan Treacy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 25, 2025

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

July 15, 2025

First Submitted That Met QC Criteria

July 15, 2025

First Posted (Actual)

July 23, 2025

Study Record Updates

Last Update Posted (Actual)

July 23, 2025

Last Update Submitted That Met QC Criteria

July 15, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CI002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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