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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-31

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical and Radiographic Outcomes of the JointMedica Polymotion Resurfacing (PHR) Device

NCT07080671

Healthy Real World Data Safety and Effectiveness +1 more

NOT_YET_RECRUITING

Metasul Monoblock Component™ Cup in a Hip Resurfacing Application With the Durom® Hip Resurfacing Femoral Component

NCT03681639

Avascular Necrosis of Hip Osteoarthritis, Hip Rheumatoid Arthritis +2 more

COMPLETED NA

Birmingham Hip Resurfacing (BHR) Study: Implantation of a Hip Resurfacing Endoprosthesis

NCT00180206

Arthritis

UNKNOWN PHASE4

Investigation of a Customized Femoral Resurfacing Implant

NCT01690689

Articular Cartilage Disorder

COMPLETED NA

Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Shell Using Simplex® or Palacos® Bone Cement

NCT00588861

Osteoarthritis, Hip Traumatic Arthritis of Hip

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes