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

JointMedica Inc.

Status: Not yet enrolling

Conditions: Real World Data; Healthy; Patient Reported Outcome (PRO); Safety and Effectiveness

Study type: Observational

Funder types: Other

Identifiers

NCT07094139

CI003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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 exclusion criteria for this study

Trial design

41 participants in 1 patient group

Patient Group

Description:

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.