Degenerative Joint DiseaseNCT04399928
EU Safety and Efficacy Study Regarding the R3 Acetabular Hip System
An observational study of Degenerative Joint Disease, run by Smith & Nephew Orthopaedics AG at 8 sites in 7 countries.
Trial summary
The objective of this study is to determine the long-term safety and effectiveness from the R3 Acetabular Hip System. The study hypothesis is that implant survivorship of the R3 cup is at least 97% at 3 years, 95% at 5 years, 93% at 7 years, and 90% at 10 years follow-up. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Degenerative Joint Disease
- What is being tested?
- Total Hip Arthroplasty
- Type of treatment
- Medical device
- How many people
- 479 participants
- Where
- 8 sitesin 7 countries
- Study dates
- 18 May 2009to 1 Apr 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This clinical study can fulfill its objectives only if appropriate subjects are enrolled. All relevant medical and non-medical conditions should be taken into consideration when deciding whether a particular patient is suitable. Subjects will be enrolled consecutively.
Who may be able to join
- Subjects must meet all of the following characteristics for inclusion in the study.
- Patient is 18-75 years old and he/she is skeletally mature
- Patient requires primary total hip arthroplasty due to non-inflammatory degenerative joint disease (e.g. osteoarthritis, post-traumatic arthritis, avascular necrosis, dysplasia/DDH or inflammatory joint disease (e.g., rheumatoid arthritis)
- Patient has met an acceptable preoperative medical clearance and is free from or treated for cardiac, pulmonary, hematological, etc., conditions that would pose excessive operative risk
- The patient is willing to comply the follow-up schedule
Who cannot join
- Subjects with any of the following characteristics must be excluded from the participation in the study.
- Patient has active infection or sepsis (treated or untreated)
- Patient is a prisoner or has an emotional or neurological condition that would pre-empt their ability or unwillingness to participate in the study including mental illness, mental retardation, linguistic insufficiencies (i.e. immigrants), or drug/alcohol abuse.
- Patients with acute hip trauma (femoral neck fracture)
Trial locations and contacts
8 sites in 7 countries.
8 sites in 7 countries
Finland2 sites
Helsinki University Hospital
Helsinki, FI-00029
TYKS Turku University Hospital
Turku, 20880
United Kingdom1 site
The Royal Orthopaedic Hospital, NHS Foundation Trust
Birmingham, B 31 2AP
About this study
Official title: A Prospective, Multicenter, Non-randomized, Clinical Outcomes Study of the R3◊ Acetabular System in Patients With Degenerative Hip Disease
The objective of this study is to determine the long-term safety and effectiveness from the R3 Acetabular Hip System. The study hypothesis is that implant survivorship of the R3 cup is at least 97% at 3 years, 95% at 5 years, 93% at 7 years, and 90% at 10 years follow-up.
Read the detailed description
This is a multicenter prospective observational post-market clinical follow-up study that will include 500 patients who will have total hip replacement with the R3 Acetabular System and either cemented or cementless hip stem.
Effectiveness will be assessed by comparison of changes in parameters contained in the HOOS questionnaire and based upon incidence of revision and change in Harris Hip Score and UCLA Rating. Safety will be measured by assessing all adverse events experienced by patients from study enrolment through to study completion.
- Conditions
- Degenerative Joint Disease
- Being tested
- Total Hip Arthroplasty
- Keywords
- Degenerative joint disease, Total Hip Arthroplasty
- Medical subject headings
- Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Hip ArthroplastyDevice
Total hip arthroplasty with the R3 Acetabular Hip system.
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Survivorship
Implant survivorship by 10 years post study procedure measured by Kaplan-Meier survival rate. Implant survival determined by no revision required for any reason. A revision is a surgical procedure of the study hip where one or more of the study components are removed and replaced with new implants.
Measured: up to 10 years post-operatively
Secondary outcomes (7)
Patient Reported Outcome (PRO): Hip Disability and Osteoarthritis Outcome Score (HOOS)
HOOS is a measurement of function and outcomes of daily living that ranges from 0 to 100 where 0 indicated extreme symptoms (i.e., worse outcome) and 100 indicated no symptoms (i.e., better outcome).
Measured: Pre-operative, 3 months, 1 years, 3 years, 5 years, 7 years, 10 years
Patient Reported Outcome (PRO): Modified Harris Hip Score (mHHS)
The mHHS scoring assessment ranges from 0 (worst) to 100 (best). Scores assessed during the pre-operative, 3-year, 5-year, 7-year and 10-year visit.
Measured: Pre-operative, 3 months, 1 years, 3 years, 5 years, 7 years, 10 years
Patient Reported Outcome (PRO): University of California, Los Angeles (UCLA) Rating
UCLA Activity Score is a measure of physical activity levels in participants undergoing total joint arthroplasty. The scale ranges from 1 to 10 with higher scores indicating greater physical function (i.e., a better outcome).
Measured: Pre-operative, 3 months, 1 years, 3 years, 5 years, 7 years, 10 years
Radiographic Findings: Atrophy
Number of participant hips with radiographic findings for atrophy indicated with a 'No', 'Yes', or 'N/A' (response not available) response at 1 year, 3 years, 5 years, 7 years, \& 10 years for the following:
- Atrophy in any Cup Zones
- Atrophy in any Stem Zones
Measured: 1 years, 3 years, 5 years, 7 years, 10 years
Radiographic Findings: Hypertrophy
Number of participant hips with radiographic findings for hypertrophy indicated with a 'No', 'Yes', or 'N/A' (response not available) response at 1 year, 3 years, 5 years, 7 years, \& 10 years for the following:
- Hypertrophy in any Cup Zones
- Hypertrophy in any Stem Zones
Measured: 1 years, 3 years, 5 years, 7 years, 10 years
Radiographic Findings: Osteolysis
Number of participant hips with radiographic findings for osteolysis greater than 2 millimeters in any cup or stem zones indicated with a 'No', 'Yes', or 'N/A' (response not available) response at 1 year, 3 years, 5 years, 7 years, \& 10 years as the following:
- Osteolysis > 2mm in any Cup Zones
- Osteolysis > 2mm in any Stem Zones
Measured: 1 years, 3 years, 5 years, 7 years, 10 years
Radiographic Findings: Radiolucent Lines (RLL)
Number of participant hips with radiographic findings for radiolucent lines (RLL) greater than 2 millimeters in any cup or stem zones indicated with a 'No', 'Yes', or 'N/A' (response not available) response at 1 year, 3 years, 5 years, 7 years, \& 10 years as the following:
- RLL > 2mm in any Cup Zones
- RLL > 2mm in any Stem Zones
Measured: 1 years, 3 years, 5 years, 7 years, 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start18 May 2009
- Primary completion18 Feb 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Degenerative Joint 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
- 479 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew Orthopaedics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Remes, Associate Professor, Principal investigator, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04399928
- Sponsor's protocol ID
- SR 16-4845-15 (R11019)
- Status last verified
- May 2022
- First submitted
- 19 May 2020
- Last updated
- 11 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Non-randomized, Clinical Outcomes Study of the R3◊ Acetabular System in Patients With Degenerative Hip Disease
- ClinicalTrials.gov ID
- NCT04399928
- Acronym / sponsor ID
- SR 16-4845-15 (R11019)
- Conditions
- Degenerative Joint Disease
- Keywords
- Degenerative joint disease, Total Hip Arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 479 participants (actual)
- Lead sponsor
- Smith & Nephew Orthopaedics AGIndustry (pharma, biotech, devices)
- Study start
- 18 May 2009 (actual)
- Primary completion
- 18 Feb 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 22 May 2020 (actual)
- Results
- Posted 11 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine the long-term safety and effectiveness from the R3 Acetabular Hip System. The study hypothesis is that implant survivorship of the R3 cup is at least 97% at 3 years, 95% at 5 years, 93% at 7 years, and 90% at 10 years follow-up.
Detailed description
This is a multicenter prospective observational post-market clinical follow-up study that will include 500 patients who will have total hip replacement with the R3 Acetabular System and either cemented or cementless hip stem.
Effectiveness will be assessed by comparison of changes in parameters contained in the HOOS questionnaire and based upon incidence of revision and change in Harris Hip Score and UCLA Rating. Safety will be measured by assessing all adverse events experienced by patients from study enrolment through to study completion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This clinical study can fulfill its objectives only if appropriate subjects are enrolled. All relevant medical and non-medical conditions should be taken into consideration when deciding whether a particular patient is suitable. Subjects will be enrolled consecutively.
Key inclusion criteria (5 listed)
- Subjects must meet all of the following characteristics for inclusion in the study.
- Patient is 18-75 years old and he/she is skeletally mature
- Patient requires primary total hip arthroplasty due to non-inflammatory degenerative joint disease (e.g. osteoarthritis, post-traumatic arthritis, avascular necrosis, dysplasia/DDH or inflammatory joint disease (e.g., rheumatoid arthritis)
- Patient has met an acceptable preoperative medical clearance and is free from or treated for cardiac, pulmonary, hematological, etc., conditions that would pose excessive operative risk
- The patient is willing to comply the follow-up schedule
Key exclusion criteria (4 listed)
- Subjects with any of the following characteristics must be excluded from the participation in the study.
- Patient has active infection or sepsis (treated or untreated)
- Patient is a prisoner or has an emotional or neurological condition that would pre-empt their ability or unwillingness to participate in the study including mental illness, mental retardation, linguistic insufficiencies (i.e. immigrants), or drug/alcohol abuse.
- Patients with acute hip trauma (femoral neck fracture)
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 ArthroplastyTotal hip arthroplasty with the R3 Acetabular Hip system. | Device | – |
Primary outcome
Implant Survivorship
Time frame: up to 10 years post-operatively
Implant survivorship by 10 years post study procedure measured by Kaplan-Meier survival rate. Implant survival determined by no revision required for any reason. A revision is a surgical procedure of the study hip where one or more of the study components are removed and replaced with new implants.
7 secondary outcomes
Patient Reported Outcome (PRO): Hip Disability and Osteoarthritis Outcome Score (HOOS)
Time frame: Pre-operative, 3 months, 1 years, 3 years, 5 years, 7 years, 10 years
Patient Reported Outcome (PRO): Modified Harris Hip Score (mHHS)
Time frame: Pre-operative, 3 months, 1 years, 3 years, 5 years, 7 years, 10 years
Patient Reported Outcome (PRO): University of California, Los Angeles (UCLA) Rating
Time frame: Pre-operative, 3 months, 1 years, 3 years, 5 years, 7 years, 10 years
Radiographic Findings: Atrophy
Time frame: 1 years, 3 years, 5 years, 7 years, 10 years
Radiographic Findings: Hypertrophy
Time frame: 1 years, 3 years, 5 years, 7 years, 10 years
Radiographic Findings: Osteolysis
Time frame: 1 years, 3 years, 5 years, 7 years, 10 years
Radiographic Findings: Radiolucent Lines (RLL)
Time frame: 1 years, 3 years, 5 years, 7 years, 10 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
Remes, Associate Professor principal investigator
University of Helsinki
8 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Joint Disease, run by Smith & Nephew Orthopaedics AG at 8 sites in 7 countries.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Finland, Belgium, Denmark, Germany, Netherlands and 2 more countries. 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?
Yes. Results are posted in the registry (first posted 11 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Implant Survivorship (time frame: up to 10 years post-operatively). 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 11 Apr 2025.