Hip DiseaseNCT07115732
ACE Acetabular Cup Spanish PMCF Study
An observational study of Hip Disease, run by JRI Orthopaedics at 1 site in Spain.
Trial summary
A total hip replacement is one of the most successful and cost-effective surgical procedures in orthopaedics, involving the replacement of both the hip ball and socket. Its goal is to provide pain relief and enable the patient to return to a normal lifestyle. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hip Disease
- What is being tested?
- Total Hip Replacement
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- Aug 2025to Jul 2036
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who require elective primary total hip replacement
Who may be able to join
- Patients deemed suitable for elective primary THR, as per indications in the IFU.
- Male or female, 18 years to 85 years.
Who cannot join
- Patients who are unable to provide written informed consent.
- Patients deemed unsuitable for THR, as per contra-indications in the IFU.
- Patients indicated for THR as a result of trauma (i.e. neck of femur fracture).
- Patients who are pregnant (exclusion criteria for THR in general).
- Patients receiving implants other than the approved combination, i.e. an ACE Acetabular Cup System with a JRI femoral stem and head.
- Patients who are unable to comply with the protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Single Centre Post Market Clinical Follow-up Study of the JRI Orthopaedic ACE Acetabular Cup System in Spain
A total hip replacement is one of the most successful and cost-effective surgical procedures in orthopaedics, involving the replacement of both the hip ball and socket. Its goal is to provide pain relief and enable the patient to return to a normal lifestyle. JRI Orthopaedics have developed the ACE Acetabular Cup System, which has an H-A.C. coating to promote osseointegration of the device within the host bone. To increase the surgeon's choice and thus suitability for the patient, there is the option of three different socket liners (ceramic, polymer, or dual mobility).
To ensure maximum safety and performance of medical devices, surveillance of the device should be carried out over the device's lifetime. This study is a 10-year surveillance study to assess the clinical, functional, and radiological outcomes of the CE-marked ACE Acetabular Cup System. This will be done by examining patient outcomes through questionnaires, reviews of X-rays, and recording any complications in patients who have received a total hip replacement using the ACE Acetabular Cup System at participating sites.
- Conditions
- Hip Disease
- Being tested
- Total Hip Replacement
- Keywords
- Total Hip Replacement, Patient reported outcome measures, Post Market Clinical Follow-up / Post Market Surveillance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Hip ReplacementDevice
Primary elective total hip replacement
| Study group | Role | What they receive |
|---|---|---|
| ACE Acetabular Cup System with XLPE Liner | Not described Receives: Device: Total Hip Replacement | |
| ACE Acetabular Cup System with Ceramic Liner | Not described Receives: Device: Total Hip Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford Hip Score
A patient completed functional score to assess pain and function of the affected hip joint. Score range: 0 (worse) to 48 (best)
Measured: 3 years post-op
Secondary outcomes (5)
Implant Survivorship
Implant survivorship based on revision rate and determined using the Kaplan-Meier analysis method
Measured: 6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op
Oxford Hip Score
A patient completed functional score to assess pain and function of the affected hip joint. Score range: 0 (worse) to 48 (best)
Measured: 6 months, 1 year, 5 years, 7 years and 10 years post-op
Modified Harris Hip Score
A patient completed functional score to assess pain and function of the affected hip joint. Score range: 0 (worse) to 100 (best)
Measured: 6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op
EQ-5D-5L
A patient completed functional score to assess quality of life of the patient. Score range: -0.594 (worse) to 1.0 (best).
Measured: 6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op
Radiological Assessment
Radiographs reviewed for signs of radiolucencies, osteolysis, sclerosis and atrophy around the device
Measured: 1 year, 5 years and 10 years post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionAug 2030 (estimated)
- Study completionJul 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JRI Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115732
- Sponsor's protocol ID
- JRI-CS-011
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single Centre Post Market Clinical Follow-up Study of the JRI Orthopaedic ACE Acetabular Cup System in Spain
- ClinicalTrials.gov ID
- NCT07115732
- Acronym / sponsor ID
- JRI-CS-011
- Conditions
- Hip Disease
- Keywords
- Total Hip Replacement, Patient reported outcome measures, Post Market Clinical Follow-up / Post Market Surveillance
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- JRI OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- Aug 2025 (estimated)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Jul 2036 (estimated)
- First posted
- 11 Aug 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.
A total hip replacement is one of the most successful and cost-effective surgical procedures in orthopaedics, involving the replacement of both the hip ball and socket. Its goal is to provide pain relief and enable the patient to return to a normal lifestyle. JRI Orthopaedics have developed the ACE Acetabular Cup System, which has an H-A.C. coating to promote osseointegration of the device within the host bone. To increase the surgeon's choice and thus suitability for the patient, there is the option of three different socket liners (ceramic, polymer, or dual mobility).
To ensure maximum safety and performance of medical devices, surveillance of the device should be carried out over the device's lifetime. This study is a 10-year surveillance study to assess the clinical, functional, and radiological outcomes of the CE-marked ACE Acetabular Cup System. This will be done by examining patient outcomes through questionnaires, reviews of X-rays, and recording any complications in patients who have received a total hip replacement using the ACE Acetabular Cup System at participating sites.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACE Acetabular Cup System with XLPE Liner | – | Device: Total Hip Replacement |
| ACE Acetabular Cup System with Ceramic Liner | – | Device: Total Hip Replacement |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who require elective primary total hip replacement
Key inclusion criteria (2 listed)
- Patients deemed suitable for elective primary THR, as per indications in the IFU.
- Male or female, 18 years to 85 years.
Key exclusion criteria (6 listed)
- Patients who are unable to provide written informed consent.
- Patients deemed unsuitable for THR, as per contra-indications in the IFU.
- Patients indicated for THR as a result of trauma (i.e. neck of femur fracture).
- Patients who are pregnant (exclusion criteria for THR in general).
- Patients receiving implants other than the approved combination, i.e. an ACE Acetabular Cup System with a JRI femoral stem and head.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Hip ReplacementPrimary elective total hip replacement | Device | ACE Acetabular Cup System with Ceramic Liner, ACE Acetabular Cup System with XLPE Liner |
Primary outcome
Oxford Hip Score
Time frame: 3 years post-op
A patient completed functional score to assess pain and function of the affected hip joint. Score range: 0 (worse) to 48 (best)
5 secondary outcomes
Implant Survivorship
Time frame: 6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op
Oxford Hip Score
Time frame: 6 months, 1 year, 5 years, 7 years and 10 years post-op
Modified Harris Hip Score
Time frame: 6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op
EQ-5D-5L
Time frame: 6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op
Radiological Assessment
Time frame: 1 year, 5 years and 10 years post-op
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 29 Aug 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hip Disease, run by JRI Orthopaedics at 1 site in Spain.
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 2 inclusion and 6 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 29 Aug 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 Spain. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxford Hip Score (time frame: 3 years post-op). 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 29 Aug 2025.