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NCT Number: NCT07094139

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

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.

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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Acetabular Cup Survivorship

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

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

  2. Radiographic Success

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

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

  3. Serious Device-Related Adverse Events

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Oyin Akintomide

CONTACT

[email protected]

+441905640008

Steve Meakins

CONTACT

[email protected]

+441905978264

Sponsors and collaborators

Lead sponsor

JointMedica Inc.

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 30, 2025
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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