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The Custom Resurfacing (CR) Implants are indicated for use for the reduction or relief of pain and/or improved hip function all skeletally mature patients where a total joint replacement is indicated, and where there is no other suitable, commercially distributed device available.
The Resurfacing System is a metal-on-polyethylene hip resurfacing device consisting of a metallic femoral component and an acetabular component made of Vitamin E HXLPE with a titanium coating on its bone-contacting surface.
The custom-Made Hip Resurfacing System is a single use device intended for hybrid fixation: cemented femoral head component and cementless acetabular component.
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 41patients who were implanted with the JointMedica Custom-Made Hip Resurfacing device in the UK.
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 JointMedica Custom-Made Hip Resurfacing 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 JointMedica Custom-Made Hip Resurfacing device (V2.1+ Cup design) between September 2020 to January 2025.
Subjects who have previously had the JointMedica Custom-Made Hip Resurfacing device implanted 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 |
|---|---|---|---|---|---|---|
| RBC Treacy Practice | Worcester | Bromsgrove | B60 4HJ | United Kingdom |
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