NCT07094139

Clinical and Radiographic Outcomes of the JointMedica Custom-Made Resurfacing Device

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 41 (estimated)
• Sponsor: JointMedica Inc. · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-03-01
• Completion: 2026-12-01
• First posted: 2025-07-30
• Last updated: 2025-07-30

Locations

1 site across 1 country: United Kingdom