Degenerative Joint Disease of HipR3 EU PASNCT03566082

Post-Approval Study of the R3 Biolox Delta Ceramic Acetabular System - Europe

An observational study of Degenerative Joint Disease of Hip, run by Smith & Nephew Orthopaedics AG at 5 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Degenerative Joint Disease of Hip
How many people: 135 participants
Where: 5 sitesin 4 countries
Study dates: 28 May 2009to 15 Oct 2021
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.

Who may be able to join

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/ developmental dysplasia of the hip) 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

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

5 sites in 4 countries.

Country

City, postcode or hospital

5 sites in 4 countries

Finland2 sites

HUS Peijaksen sairaala, Ortopedia ja traumatologia
Helsinki, 00029
TYKS Turku University Hospital
Turku, 20880

Other trials in Finland

Belgium1 site

AZ Nikolaas
Sint-Niklaas

Other trials in Belgium

Spain1 site

La Paz Hospital
Madrid, 28046

Other trials in Spain

United Kingdom1 site

The Royal Orthopaedic Hospital, NHS Foundation Trust
Birmingham, B 31 2AP

Other trials in United Kingdom

About this study

Read the detailed description

This PAS is a long-term follow-up of the R3 delta Ceramic Acetabular System (DOD) hips enrolled in the study that was analyzed for the Premarket Approval Application (PMA) Study. The PMA Study analyzed 3 Year postoperative follow-up data on Biolox delta ceramic-on-Biolox delta ceramic (DOD) and Oxidized zirconium-on-Crosslinked Polyethylene (OxZr/XLPE) hips, enrolled and followed in a European Post-market Study ("A prospective, multicenter, non-randomized, clinical outcome study of the R3 Acetabular System in patients with degenerative hip disease").

The purpose of this prospective, multicenter, single arm study is to confirm the long-term safety and effectiveness of the R3 delta Ceramic Acetabular System PMA (P150030) by evaluating long-term (10 years after surgery) follow-up results. Hips are evaluated at the following intervals: 5, 7, 10 years postoperative. The primary study endpoint is implant survivorship at 10 years post surgery.

Conditions: Degenerative Joint Disease of Hip
Medical subject headings: Osteoarthritis, Hip

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03566082
Study group	Role	What they receive
Post Approval Study		The PAS cohort consisted of 137 subjects who were implanted with the R3 delta Ceramic Acetabular System (DoD) in the pivotal study. These patients will continue to be followed to 10 years post-operatively. The primary endpoint for the PAS study is implant survivorship at 10 years post study procedure.

What is being measured

The primary outcome is the main question the study is designed to answer.

Implant Survivorship
Number of participants hip implant survivorship with implant survival defined as no revision through 10 years (i.e., 'Hip Survived' or 'Hip Did Not Survive').
Measured: 10 Years

Secondary outcomes (2)

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-years, 5-years, 7-years, 10-years
Number of Participants With Radiographic Success
Count of participants with radiographic success, where success is defined as:
- No radiolucencies greater than 2 mm in 50% or more in any of the cup or stem zones; and
- No femoral or acetabular subsidence greater than or equal to 5mm from baseline; and
- No acetabular cup inclination changes greater than 4 degrees (4°)
Participants who did not meet criteria specified above were considered radiographic failures
Measured: 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.

28 May 200915 Oct 2021

First posted21 Jun 2018
Study start28 May 2009
Primary completion15 Oct 2021
Study completion15 Oct 2021

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Degenerative Joint Disease of HipStudies 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: 135 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03566082
Sponsor's protocol ID: R11019
Acronym: R3 EU PAS
Status last verified: Aug 2023
First submitted: 10 Jan 2018
Last updated: 30 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Davis ET, Remes V, Virolainen P, Gebuhr P, Van Backle B, Revell MP, Kopjar B. Mid-term outcomes of the R3 delta ceramic acetabular system in total hip arthroplasty. J Orthop Surg Res. 2021 Jan 9;16(1):35. doi: 10.1186/s13018-020-02192-6.
PubMed 33422084

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Degenerative Joint Disease of Hip trials

Study at a glance

From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-Approval Study of the R3 Biolox Delta Ceramic Acetabular System - Europe
ClinicalTrials.gov ID: NCT03566082
Acronym / sponsor ID: R3 EU PAS / R11019
Conditions: Degenerative Joint Disease of Hip
Study type: Observational
Recruitment status: Completed
Enrolment: 135 participants (actual)
Lead sponsor: Smith & Nephew Orthopaedics AGIndustry (pharma, biotech, devices)
Collaborators: eResearchTechnology, Inc, M Squared Associates, Inc., ExecuPharm PAREXEL, IQVIA Pty Ltd
Study start: 28 May 2009 (actual)
Primary completion: 15 Oct 2021 (actual)
Study completion: 15 Oct 2021 (actual)
First posted: 21 Jun 2018 (actual)
Results: Posted 30 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Post Approval Study	–	–The PAS cohort consisted of 137 subjects who were implanted with the R3 delta Ceramic Acetabular System (DoD) in the pivotal study. These patients will continue to be followed to 10 years post-operatively. The primary endpoint for the PAS study is implant survivorship at 10 years post study procedure.

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.

Key inclusion criteria (4 listed)

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/ developmental dysplasia of the hip) 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 (3 listed)

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.

Primary outcome

Implant Survivorship
Time frame: 10 Years
Number of participants hip implant survivorship with implant survival defined as no revision through 10 years (i.e., 'Hip Survived' or 'Hip Did Not Survive').

2 secondary outcomes

Modified Harris Hip Score (mHHS)
Time frame: Pre-operative, 3-years, 5-years, 7-years, 10-years
Number of Participants With Radiographic Success
Time frame: 3-years, 5-years, 7-years 10-years

Results and safety

Results posted to the registry on 30 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Post Approval Study	135	118

Primary outcome: Implant Survivorship

Time frame: 10 Years. Count of participants. Unit: Participants

Measure	Post Approval Study n = 135
Hip Survived	133
Hip Did Not Survive (Revision Required)	2

Population analysed: Participants with any data available at the time frame specified

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) through 10 years.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Post Approval Study	83 of 135 (61.5%)	99 of 135 (73.3%)	7 of 135

Limitations and caveats (from the sponsor): At the 10+ Year interval, the follow-up rates that require collection of additional data for the secondary endpoints, ActualA-In-Window and ActualA, are 77.0% and 78.6%, respectively, for all hips. The additional analyses that were done to assess the impact of protocol deviations incurred including those resulting from the COVID-19 pandemic support that the missing data are unlikely to have an impact on the primary or secondary endpoint results.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33422084Davis ET, Remes V, Virolainen P, Gebuhr P, Van Backle B, Revell MP, Kopjar B. Mid-term outcomes of the R3 delta ceramic acetabular system in total hip arthroplasty. J Orthop Surg Res. 2021 Jan 9;16(1):35. doi: 10.1186/s13018-020-02192-6.

Related trials for Degenerative Joint Disease of Hip

Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Recruiting
Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
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RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
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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.

The record lists no contact. Use the official record to reach the sponsor.

5 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Degenerative Joint Disease of Hip, run by Smith & Nephew Orthopaedics AG at 5 sites in 4 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 4 inclusion and 3 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 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Finland, Belgium, Spain, 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?

Yes. Results are posted in the registry (first posted 30 May 2024). 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: 10 Years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03566082, which also lists 1 linked publication.

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 May 2024.