Clinical and Radiographic Outcomes of the JointMedica Polymotion Resurfacing (PHR) Device
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Healthy, Real World Data, Safety and Effectiveness, Patient Reported Outcome (PRO). Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia, Canada, New Zealand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Acetabular Cup Survivorship [Time frame: 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.]
- Serious Device-Related Adverse Events [Time frame: From primary implantation to post-operative visit at 24-months or 27+months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-only
Study locations
Australia · 1 center
- Mark Rickman — Adelaide
Canada · 1 center
- Gateway Surgery Centre — Calgary
New Zealand · 1 center
- Orthopaedic Specialist Centre — Auckland
Identifiers
NCT: NCT07080671 · CI002