Healthy, Patient Reported Outcome (PRO), Real World Data, Safety and Effectiveness
Conditions
Keywords
Custom-Made Hip Resurfacing, Hip Resurfacing, Hip Arthroplasty
Brief summary
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: * 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 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.
Interventions
None listed
Sponsors
JointMedica Inc.
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age 21 or above at the time of the surgery. * Have had the JointMedica Custom-Made Hip Resurfacing device implanted between September 2020 to January 2025 * Written informed consent given by subject
Exclusion criteria
* There is no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acetabular Cup Survivorship | 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 | 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 | 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. |
Countries
United Kingdom
Contacts
Primary ContactSteve Meakins
Backup ContactOyin Akintomide
Outcome results
None listed