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

NCT07094139 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 41

Last updated 2025-07-30

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • JointMedica Inc.

    lead OTHER

Principal Investigators

  • Ronan Treacy

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-31
Primary Completion
2026-03-31
Completion
2026-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07094139 on ClinicalTrials.gov