Degenerative Joint DiseaseR3-PASNCT03056534

R3 Delta Ceramic Acetabular System PAS U.S.

An observational study of Degenerative Joint Disease, run by Smith & Nephew, Inc. at 8 sites in United States.

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

R3 Delta Post-Approval Study U.S. 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?: R3 Biolox Delta Ceramic Acetabular System
Type of treatment: Medical device
How many people: 189 participants
Where: 8 sitesUnited States
Study dates: 7 Feb 2018to 31 May 2023
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
Adult, Older adult

Study population: To eliminate the potential for selection bias, Investigators should consecutively pre-screen all subjects undergoing planned total hip replacement with the R3 delta Ceramic Acetabular System.

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 (degenerative joint disease) such as osteoarthritis, avascular necrosis, or traumatic 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
Patient is willing and able to participate in required follow-up visits and to complete study procedures and questionnaires
Patient has consented to participating in the study by signing the IRB/EC approved informed consent form

Who cannot join

Patients with insufficient quantity or quality of bone support; metabolic bone disease; osteoporosis
Patients with neurological or muscular conditions that would place extreme load or instability upon the hip joint
Patients with active joint infections or chronic systemic infection
Obese patients where obesity is defined as BMI ≥ 40
Skeletal immaturity
Known allergy to implant materials

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Luminis Health
Annapolis, Maryland, 21401
St. David's Center for Hip and Knee Replacement
Austin, Texas, 78750
Rubin Institute for Advanced Orthopedics, Sinai Hospital
Baltimore, Maryland, 21215
INOV8 Healthcare
Houston, Texas, 77043
University of Pennsylvania, Department of Orthopaedic Surgery
Philadelphia, Pennsylvania, 19104
Reno Orthopaedic Clinic Foundation
Reno, Nevada, 89503
Foundation for Orthopaedic Research and Education
Tampa, Florida, 33637
Emory University
Tucker, Georgia, 30084

Other trials in United States

About this study

Official title: Post-Approval Study of the R3 Biolox Delta Ceramic Acetabular System - US

R3 Delta Post-Approval Study U.S.

Read the detailed description

Post-Approval Study of the R3 Biolox Delta Ceramic Acetabular System - US The R3 Ceramic Acetabular System is indicated for use in skeletally mature patients requiring primary total hip arthroplasty due to non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, avascular necrosis, or traumatic arthritis. The expected timeline for the study is a total of approximately 5 years: 6 months for site initiation, 12 months for subject enrollment, 3 years until the last subject enrolled has reached the 3 year follow-up interval.

Conditions: Degenerative Joint Disease
Being tested: R3 Biolox Delta Ceramic Acetabular System
Keywords: Primary Total Hip Arthroplasty, Non-Inflammatory Arthritis, Degenerative Joint Disease, R3 Delta Ceramic Acetabular Insert
Medical subject headings: Joint Diseases

What participants receive

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

R3 Biolox Delta Ceramic Acetabular SystemDevice
All study related procedures with the R3 delta Ceramic Acetabular System must be performed according to the recommended surgical technique described in the labeling and in the instructions for use (IFU).

What is being measured

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

Overall Study Success at 3 Years Postoperative
Number of participants with overall study success were identified as "Success" or "Failure" where success indicated all the following:
- No component revision for any reason
- Modified Harris Hip Score (mHHS) greater than or equal to 80 points
- No radiographic failure (Radiographic failure was defined as no radiolucencies greater than 2 millimeters (mm) in 50% or more in any of the cup or stem zones, no femoral or acetabular subsidence greater than or equal to 5 mm from baseline, and no acetabular cup inclination changes greater than 4 degrees from baseline when accompanied by a "Mild", "Moderate", "Marked" or "Disabled" mHHS pain score.)
Measured: 3 Years Postoperative
Component Revisions at 3 Years Postoperative
Number of participants component revisions identified as "Success" or "Failure" with success defined as no component revision for any reason.
Measured: 3 Years Postoperative
Number of Participants With Modified Harris Hip Score Greater Than or Equal to 80 Points
The Harris Hip Score (HHS) is a joint specific score that consists of 10 items covering domains of pain, function, functional activities, absence of deformity, and hip range of motion. The modified Harris Hip Score (mHHS) includes all the same domains as the HHS except for the hip range of motion. Total mHHS scale ranges from 0 (worst) to 95 (best). The number of participants were identified as "Success" or "Failure" with success defined as a mHHS that is greater than or equal to 80 points.
Measured: 3 Years postoperative
Overall Radiographic Success at 3 Years Postoperative
Number of participants with overall radiographic success identified as "Success" or "Failure" where success indicated all of the following:
- No radiolucencies greater than 2 millimeters (mm) in 50% or more in any of the cup or stem zones
- No femoral or acetabular subsidence greater than or equal to 5 mm from baseline
- No acetabular cup inclination changes greater than 4 degrees from baseline when accompanied by a "Mild", "Moderate", "Marked" or "Disabled" mHHS pain score
Measured: 3 Years Postoperative
Number of Participants With Absence of Radiolucency at 3 Years Postoperative
Number of participants identified as "Success" or "Failure" with success defined as no radiolucencies greater than 2 millimeters (mm) in 50% or more in any of the cup or stem zones
Measured: 3 Years postoperative
Number of Participants With Absence of Femoral Subsidence or Acetabular Migration at 3 Years Postoperative
Number of participants identified as "Success" or "Failure" with success defined as no femoral subsidence or acetabular migration greater than or equal to 5 millimeters (mm) from baseline.
Measured: 3 Years postoperative
Number of Participants With Absence of Acetabular Cup Inclination Changes Greater Than 4 Degrees From Baseline at 3 Years Postoperative
Number of participants identified as "Success" or "Failure" with success defined as no acetabular cup inclination changes greater than 4 degrees from baseline when accompanied by a "Mild", "Moderate", "Marked" or "Disabled" mHHS pain score.
Measured: 3 Years postoperative

Secondary outcomes (5)

Modified Hip Harris Score (mHHS)
The Harris Hip Score (HHS) is a joint specific score that consists of 10 items covering domains of pain, function, functional activities, absence of deformity, and hip range of motion. The modified Harris Hip Score (mHHS) includes all the same domains as the HHS except for the hip range of motion. Total mHHS scale ranges from 0 (worst) to 95 (best).
Measured: Preoperative, 3 months, 1 year, 2 years, 3 years
Radiographic Findings: Number of Participants With Absence of Radiolucency
The number of participants identified as either "Success" or "Failure" with success defined as no radiolucencies greater than 2 millimeters (mm) in 50% or more in any of the cup or stem zones when accompanied by a "Mild", "Moderate", "Marked" or "Disabled" pain modified Harris Hip Score (mHHS).
Measured: 3 months, 1 year, 2 years
Radiographic Findings: Number of Participants With Absence of Femoral Subsidence or Acetabular Migration
The number of participants identified as either "Success" or "Failure" with success defined as no femoral subsidence or acetabular migration greater than or equal to 5 millimeters (mm) from baseline when accompanied by a "Mild", "Moderate", "Marked" or "Disabled" pain modified Harris Hip Score (mHHS).
Measured: 3 months, 1 year, 2 years
Radiographic Findings: Number of Participants With Absence of Acetabular Cup Inclination Changes
Number of participants identified as "Success" or "Failure" with success defined as no acetabular cup inclination changes greater than 4 degrees from baseline when accompanied by a "Mild", "Moderate", "Marked" or "Disabled" pain modified Harris Hip Score (mHHS).
Measured: 3 months, 1 year, and 2 years
Implant Survivorship Kaplan-Meier Estimate
The Kaplan-Meier estimate of implant survivorship was measured from date of surgery to date of final visit with survival defined as no revision for any reason. A revision indicated reoperation was needed where any component (acetabular cup, acetabular liner, femoral head, or femoral stem) was replaced.
Measured: Postoperatively, up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Feb 201831 May 2023

First posted17 Feb 2017
Study start7 Feb 2018
Primary completion31 May 2023
Study completion31 May 2023

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: 189 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03056534
Sponsor's protocol ID: 16-4565-10
Acronym: R3-PAS
Status last verified: Feb 2024
First submitted: 6 Feb 2017
Last updated: 13 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2025. 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 - US
ClinicalTrials.gov ID: NCT03056534
Acronym / sponsor ID: R3-PAS / 16-4565-10
Conditions: Degenerative Joint Disease
Keywords: Primary Total Hip Arthroplasty, Non-Inflammatory Arthritis, Degenerative Joint Disease, R3 Delta Ceramic Acetabular Insert
Study type: Observational
Recruitment status: Completed
Enrolment: 189 participants (actual)
Lead sponsor: Smith & Nephew, Inc.Industry (pharma, biotech, devices)
Study start: 7 Feb 2018 (actual)
Primary completion: 31 May 2023 (actual)
Study completion: 31 May 2023 (actual)
First posted: 17 Feb 2017 (actual)
Results: Posted 13 Apr 2025

Clinical summary

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

R3 Delta Post-Approval Study U.S.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 to 75 years
Sex: All
Age groups: Adult, Older adult
Study population: To eliminate the potential for selection bias, Investigators should consecutively pre-screen all subjects undergoing planned total hip replacement with the R3 delta Ceramic Acetabular System.

Key inclusion criteria (5 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 (degenerative joint disease) such as osteoarthritis, avascular necrosis, or traumatic 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
Patient is willing and able to participate in required follow-up visits and to complete study procedures and questionnaires
Patient has consented to participating in the study by signing the IRB/EC approved informed consent form

Key exclusion criteria (6 listed)

Patients with insufficient quantity or quality of bone support; metabolic bone disease; osteoporosis
Patients with neurological or muscular conditions that would place extreme load or instability upon the hip joint
Patients with active joint infections or chronic systemic infection
Obese patients where obesity is defined as BMI ≥ 40
Skeletal immaturity

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
R3 Biolox Delta Ceramic Acetabular SystemAll study related procedures with the R3 delta Ceramic Acetabular System must be performed according to the recommended surgical technique described in the labeling and in the instructions for use (IFU).	Device	–

Primary outcome

Overall Study Success at 3 Years Postoperative
Time frame: 3 Years Postoperative
Number of participants with overall study success were identified as "Success" or "Failure" where success indicated all the following: * No component revision for any reason * Modified Harris Hip Score (mHHS) greater than or equal to 80 points * No radiographic failure (Radiographic failure was defined as no radiolucencies greater than 2 millimeters (mm) in 50% or more in any of the cup or stem zones, no femoral or acetabular subsidence greater than or equal to 5 mm from baseline, and no acetabular cup inclination changes greater than 4 degrees from baseline when accompanied by a "Mild", "Moderate", "Marked" or "Disabled" mHHS pain score.)
Component Revisions at 3 Years Postoperative
Time frame: 3 Years Postoperative
Number of participants component revisions identified as "Success" or "Failure" with success defined as no component revision for any reason.
Number of Participants With Modified Harris Hip Score Greater Than or Equal to 80 Points
Time frame: 3 Years postoperative
The Harris Hip Score (HHS) is a joint specific score that consists of 10 items covering domains of pain, function, functional activities, absence of deformity, and hip range of motion. The modified Harris Hip Score (mHHS) includes all the same domains as the HHS except for the hip range of motion. Total mHHS scale ranges from 0 (worst) to 95 (best). The number of participants were identified as "Success" or "Failure" with success defined as a mHHS that is greater than or equal to 80 points.
Overall Radiographic Success at 3 Years Postoperative
Time frame: 3 Years Postoperative
Number of participants with overall radiographic success identified as "Success" or "Failure" where success indicated all of the following: * No radiolucencies greater than 2 millimeters (mm) in 50% or more in any of the cup or stem zones * No femoral or acetabular subsidence greater than or equal to 5 mm from baseline * No acetabular cup inclination changes greater than 4 degrees from baseline when accompanied by a "Mild", "Moderate", "Marked" or "Disabled" mHHS pain score
Number of Participants With Absence of Radiolucency at 3 Years Postoperative
Time frame: 3 Years postoperative
Number of participants identified as "Success" or "Failure" with success defined as no radiolucencies greater than 2 millimeters (mm) in 50% or more in any of the cup or stem zones
Number of Participants With Absence of Femoral Subsidence or Acetabular Migration at 3 Years Postoperative
Time frame: 3 Years postoperative
Number of participants identified as "Success" or "Failure" with success defined as no femoral subsidence or acetabular migration greater than or equal to 5 millimeters (mm) from baseline.
Number of Participants With Absence of Acetabular Cup Inclination Changes Greater Than 4 Degrees From Baseline at 3 Years Postoperative
Time frame: 3 Years postoperative
Number of participants identified as "Success" or "Failure" with success defined as no acetabular cup inclination changes greater than 4 degrees from baseline when accompanied by a "Mild", "Moderate", "Marked" or "Disabled" mHHS pain score.

5 secondary outcomes

Modified Hip Harris Score (mHHS)
Time frame: Preoperative, 3 months, 1 year, 2 years, 3 years
Radiographic Findings: Number of Participants With Absence of Radiolucency
Time frame: 3 months, 1 year, 2 years
Radiographic Findings: Number of Participants With Absence of Femoral Subsidence or Acetabular Migration
Time frame: 3 months, 1 year, 2 years
Radiographic Findings: Number of Participants With Absence of Acetabular Cup Inclination Changes
Time frame: 3 months, 1 year, and 2 years
Implant Survivorship Kaplan-Meier Estimate
Time frame: Postoperatively, up to 3 years

Results and safety

Results posted to the registry on 13 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
R3™ Biolox® Delta Ceramic Acetabular System	189	131

Primary outcome: Overall Study Success at 3 Years Postoperative

Time frame: 3 Years Postoperative. Count of participants. Unit: Participants

Measure	R3™ Biolox® Delta Ceramic Acetabular System n = 113
Success	100
Failure	13

Population analysed: Overall number of participants with data collected for the time frame indicated.

Primary outcome: Component Revisions at 3 Years Postoperative

Time frame: 3 Years Postoperative. Count of participants. Unit: Participants

Measure	R3™ Biolox® Delta Ceramic Acetabular System n = 136
Success	135
Failure	1

Population analysed: Overall number of participants with data collected for the time frame indicated.

Primary outcome: Number of Participants With Modified Harris Hip Score Greater Than or Equal to 80 Points

Time frame: 3 Years postoperative. Count of participants. Unit: Participants

Measure	R3™ Biolox® Delta Ceramic Acetabular System n = 124
Success	114
Failure	10

Population analysed: Overall number of participants with data collected for the time frame indicated.

Primary outcome: Overall Radiographic Success at 3 Years Postoperative

Time frame: 3 Years Postoperative. Count of participants. Unit: Participants

Measure	R3™ Biolox® Delta Ceramic Acetabular System n = 108
Success	106
Failure	2

Population analysed: Overall number of participants with data collected for the time frame indicated.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected upon implantation of device through study completion, up to 3 years.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
R3™ Biolox® Delta Ceramic Acetabular System	70 of 189 (37%)	101 of 189 (53.4%)	4 of 189

Limitations and caveats (from the sponsor): The impact of the COVID-19 pandemic on participant retention, out of window follow-up visits, and data acquisition due to participants being unable or not willing to undergo study assessments at follow-up visits. Primary outcome analyses were not impacted by COVID-19. Data missing for secondary outcome analyses was low and risks were mitigated by appropriate alternative data collection methods.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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. This study is not recruiting at the moment.

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

8 sites in 1 country: 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, Inc. at 8 sites in United States.

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 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: finished, as of the sponsor's last update on 13 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 United States. 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 13 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?

Overall Study Success at 3 Years Postoperative (time frame: 3 Years Postoperative). The study lists 7 primary outcomes in all. 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 NCT03056534.

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 13 Apr 2025.