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

NCT07080671 | Not Yet Recruiting

• 1 other identifier: CI002
• Study Type: observational
• Target: 105
• Locations: 3 countries
• Sites: 3

Brief Summary

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

PHR; Polymotion Hip Resurfacing; Polymotion

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 Polymotion Hip Resurfacing (PHR) 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 Polymotion Hip Resurfacing (PHR) System (V3.1 Cup design) between September 2020 to January 2025. Subjects who have previously had the Polymotion Hip Resurfacing (PHR) System implanted at the sites 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 Polymotion Hip Resurfacing (PHR) (implanted between September 2020 to January 2025
• Written informed consent given by subject

Sponsors & Collaborators

• JointMedica Inc.: lead

Study Sites (3)

Mark Rickman

Adelaide, Australia

Location

Gateway Surgery Centre

Calgary, Alberta, T2C 3G3, Canada

Location

Orthopaedic Specialist Centre

Auckland, New Zealand

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 15, 2025
• First Posted: July 23, 2025
• Study Start: July 25, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

NZ (1); AU (1); CA (1)