HealthyNCT07094139
Clinical and Radiographic Outcomes of the JointMedica Custom-Made Resurfacing Device
An observational study of Healthy and Real World Data, run by JointMedica Inc. at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Real World Data, Safety and Effectiveness
- How many people
- 41 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- There is no exclusion criteria for this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
RBC Treacy Practice
Worcester, Bromsgrove, B60 4HJ
Wendy Richards, +44121 454 6161, Treacyhip@aol.com
About this study
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.
Read more
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.
Read the detailed 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.
- Keywords
- Custom-Made Hip Resurfacing, Hip Resurfacing, Hip Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acetabular Cup Survivorship
The number of acetabular cups which are functional and not requiring additional surgical intervention following the primary implantation
Measured: 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
Measured: 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.
Measured: From primary implantation to post-operative visit at 24-months or 27+months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study startAug 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JointMedica Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronan Treacy, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094139
- Sponsor's protocol ID
- CI003
- Status last verified
- Jul 2025
- First submitted
- 23 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Outcomes of the JointMedica Custom-Made Resurfacing Device
- ClinicalTrials.gov ID
- NCT07094139
- Acronym / sponsor ID
- CI003
- Keywords
- Custom-Made Hip Resurfacing, Hip Resurfacing, Hip Arthroplasty
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- JointMedica Inc.University, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- There is no exclusion criteria for this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ronan Treacy principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Real World Data, run by JointMedica Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Steve Meakins (+441905978264, steve@jointmedica.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acetabular Cup Survivorship (time frame: From the primary implantation to end through to 24 months and 27months+ post operation.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.