OsteoarthritisNCT01407029
R3® Acetabular System in Patients With Degenerative Hip Disease
An observational study of Osteoarthritis, run by Smith & Nephew, Inc. at 8 sites in 2 countries.
Trial summary
This is a prospective, non-randomized, consecutive series, multicenter clinical study that will include patients who will have total hip replacement with the R3 Acetabular System. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- How many people
- 158 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Oct 2009to 14 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- 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 of legal age to consent and skeletally mature.
- Patient requires primary total hip arthroplasty due to non-inflammatory degenerative joint disease (e.g. osteoarthritis, traumatic arthritis, avascular necrosis, and dysplasia/DDH)
- 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 will be available for follow-up throughout the duration of the study.
Who cannot join
- Patient has active infection or sepsis (treated or untreated)
- Patient has any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery.
- Patient is pregnant or plans to become pregnant during the course of the study Patient has inadequate bone stock to support the device (e.g. severe osteopenia, family history of severe osteoporosis or osteopenia)
- Patient has inflammatory joint disease (e.g. rheumatoid arthritis)
- Patient has known moderate to severe renal insufficiency.
- Patient has a known or suspected metal sensitivity.
Show all 10Show fewer
- Patient is immunosuppressed or receiving high doses of corticosteroids.
- Patient has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, or drug, alcohol abuse.
- Patient has BMI >40.
- Patient is a prisoner
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States5 sites
Ortho Carolina
Charlotte, North Carolina, 28207
Midwest Orthopedics at Rush University Medical Center
Chicago, Illinois, 60612
Novant Health Pinnacle Orthopedics
Salisbury, North Carolina, 28144
Washington University Orthopedics
St Louis, Missouri, 63110
Orthopedic Center of Vero Beach
Vero Beach, Florida, 32960
Canada3 sites
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7
London Health Science Center
London, Ontario
Concordia Hip and Knee Institute
Winnipeg, Manitoba, R2K 2M9
About this study
Official title: A Prospective, Multicenter, Non-randomized, Clinical Outcomes Study of the R3® Acetabular System in Patients With Degenerative Hip Disease
This is a prospective, non-randomized, consecutive series, multicenter clinical study that will include patients who will have total hip replacement with the R3 Acetabular System.
Read the detailed description
The study design was selected to assess the safety and effectiveness profile of the R3 Acetabular System in patients with degenerative joint disease requiring primary total hip replacement. A non¬-randomized, consecutive series of up to 158 patients will be enrolled, and a maximum of 8 sites will participate in the study. Each site is allowed to enroll up to 22 patients. When 158 patients are enrolled from all sites, enrollment will be stopped, regardless of the number contributed from each site. The clinical data from this study will be compared with a historical control. The study will include follow up through 5 years.
- Conditions
- Osteoarthritis
- Medical subject headings
- Osteoarthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness will be measured using the Harris Hip Score (HHS), The HOOS self assessment questionnaire, and radiographic assessment. Radiographic measures consist of radiolucencies, component position changes, and bony changes.
The objective of this study is to establish the safety and effectiveness of the R3 Acetabular System in primary total hip replacement.
Measured: 3 months, 1-5 years
Secondary outcomes (1)
Adverse Events
All perioperative and postoperative device-related and surgical adverse events will be recorded during this study.
Measured: Post Operative - 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study startOct 2009
- Primary completion14 Mar 2017
- Study completion14 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard McCalden, MD, Principal investigator, London Health Science Centre-University Hospital London OntarioColin Burnell, MD, Principal investigator, Concordia Hospital, Winnipeg, CanadaJames Comadoll, MD, Principal investigator, Ro Medical Orthopedics, Salisbury NCRichard Steinfeld, MD, Principal investigator, Orthopaedic Center of Vero Beach, Vero Beach, FLCraig Della Valle, MD, Principal investigator, Rush University Medical CenterJohn Masonis, MD, Principal investigator, OrthoCarolina Research InstituteRyan Nunley, MD, Principal investigator, Washington University OrthopedicsMichael Dunbar, MD, Principal investigator, Halifax Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01407029
- Sponsor's protocol ID
- R3H01
- Status last verified
- Apr 2017
- First submitted
- 6 Aug 2010
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. 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
- NCT01407029
- Acronym / sponsor ID
- R3H01
- Conditions
- Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2009 (actual)
- Primary completion
- 14 Mar 2017 (actual)
- Study completion
- 14 Mar 2017 (actual)
- First posted
- 1 Aug 2011 (estimated)
- 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.
This is a prospective, non-randomized, consecutive series, multicenter clinical study that will include patients who will have total hip replacement with the R3 Acetabular System.
Detailed description
The study design was selected to assess the safety and effectiveness profile of the R3 Acetabular System in patients with degenerative joint disease requiring primary total hip replacement. A non¬-randomized, consecutive series of up to 158 patients will be enrolled, and a maximum of 8 sites will participate in the study. Each site is allowed to enroll up to 22 patients. When 158 patients are enrolled from all sites, enrollment will be stopped, regardless of the number contributed from each site. The clinical data from this study will be compared with a historical control. The study will include follow up through 5 years.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- 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 of legal age to consent and skeletally mature.
- Patient requires primary total hip arthroplasty due to non-inflammatory degenerative joint disease (e.g. osteoarthritis, traumatic arthritis, avascular necrosis, and dysplasia/DDH)
- 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 will be available for follow-up throughout the duration of the study.
Key exclusion criteria (10 listed)
- Patient has active infection or sepsis (treated or untreated)
- Patient has any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery.
- Patient is pregnant or plans to become pregnant during the course of the study Patient has inadequate bone stock to support the device (e.g. severe osteopenia, family history of severe osteoporosis or osteopenia)
- Patient has inflammatory joint disease (e.g. rheumatoid arthritis)
- Patient has known moderate to severe renal insufficiency.
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
Effectiveness will be measured using the Harris Hip Score (HHS), The HOOS self assessment questionnaire, and radiographic assessment. Radiographic measures consist of radiolucencies, component position changes, and bony changes.
Time frame: 3 months, 1-5 years
The objective of this study is to establish the safety and effectiveness of the R3 Acetabular System in primary total hip replacement.
1 secondary outcome
Adverse Events
Time frame: Post Operative - 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- 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.
Richard McCalden, MD principal investigator
London Health Science Centre-University Hospital London Ontario
Colin Burnell, MD principal investigator
Concordia Hospital, Winnipeg, Canada
James Comadoll, MD principal investigator
Ro Medical Orthopedics, Salisbury NC
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by Smith & Nephew, Inc. at 8 sites in 2 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 10 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 25 Apr 2017. 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, Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effectiveness will be measured using the Harris Hip Score (HHS), The HOOS self assessment questionnaire, and radiographic assessment. Radiographic measures consist of radiolucencies, component position changes, and bony changes. (time frame: 3 months, 1-5 years). 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 25 Apr 2017.