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

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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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mark Rickman, Adelaide, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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
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
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.

Study contacts

Contact information is provided by the study sponsor or research team.

Oyin Akintomide

CONTACT

[email protected]

+441905640008

Steve Meakins

CONTACT

[email protected]

+441905978264

Sponsors and collaborators

Lead sponsor

JointMedica Inc.

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jul 23, 2025
Registry last updated: Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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