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

NCT07094139 | Not Yet Recruiting

• 1 other identifier: CI003
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Custom-Made Hip Resurfacing; Hip Resurfacing; Hip Arthroplasty

Outcome Measures

Primary Outcomes (3)

• Acetabular Cup Survivorship

  The number of acetabular cups which are functional and not requiring additional surgical intervention following the primary implantation

  From the primary implantation to end through to 24 months and 27months+ post operation.

• Radiographic Success

  Quantitative motion assessment of the acetabular cup at implantation and follow-up visit

  Between primary implantation surgery and post-operative review at 24-months and 27+ months.

• Serious Device-Related Adverse Events

  Occurrence and severity of adverse events including necessitation of secondary surgical intervention.

  From primary implantation to post-operative visit at 24-months or 27+months

Study Arms (1)

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.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects that underwent hip arthroplasty procedure with the JointMedica Custom-Made Hip Resurfacing device (V2.1+ Cup design) between September 2020 to January 2025. Subjects who have previously had the JointMedica Custom-Made Hip Resurfacing device implanted will be contacted to give consent to participate in the collection of additional follow-up visits described within this protocol.

You may qualify if:

• 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

Sponsors & Collaborators

• JointMedica Inc.: lead

Study Sites (1)

RBC Treacy Practice

Worcester, Bromsgrove, B60 4HJ, United Kingdom

Location

Study Officials

• Ronan Treacy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steve Meakins

CONTACT

+441905978264; steve@jointmedica.com

Oyin Akintomide

CONTACT

+441905640008; oyin@jointmedica.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: July 30, 2025
• Study Start: August 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)