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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Acetabular Cup Survivorship | 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 | 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Steve Meakins | Contact | +441905978264 | steve@jointmedica.com | |
| Oyin Akintomide | Contact | +441905640008 | oyin@jointmedica.com |
| Name | Affiliation | Role |
|---|---|---|
| Ronan Treacy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mark Rickman | Adelaide | Australia |
|
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| Gateway Surgery Centre | Calgary | Alberta | T2C 3G3 | Canada |
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| Orthopaedic Specialist Centre | Auckland | New Zealand |
|