OsteoarthritisNCT01921309
Trinity™ BIOLOX Delta™ CoC THR Multi-center Study
A study testing Trinity CoC Total Hip System and Trinity Ceramic-on-Poly THR in people with Osteoarthritis and Avascular Necrosis, run by Corin at 10 sites in 2 countries.
Trial summary
To demonstrate the safety and effectiveness of the Trinity™ BIOLOX delta™ Ceramic-on-Ceramic Total Hip System in comparison to the Trinity™ Acetabular Hip System,which is FDA cleared for use in the U.S. The comparison will be based upon clinical success at the Month 24 endpoint. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis
- What is being tested?
- Trinity CoC Total Hip System and Trinity Ceramic-on-Poly THR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Dec 2012to Dec 2021
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- preoperative Harris Hip Score of ≤ 70.
- preoperative Harris Hip Total Pain score of at least moderate.
- diagnosed with non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, rheumatoid arthritis, correction of functional deformity, developmental hip dysplasia (DDH) and congenital hip dysplasia (CDH).
- pain rating of none or slight and are at least 12 months post-operative in the contralateral hip, if applicable.
- have sufficient femoral and acetabular bone stock as determined by a clinician, and are suitable to receive implants as confirmed by x-rays.
Who cannot join
- have a nutritional problem (protein, calorie, or vitamin/mineral deficiency) that may impair wound healing mechanisms as determined by the clinician /investigator.
- have a neurological disorders which may interfere or adversely affect gait, balance, or weight bearing (e.g. muscular dystrophy, multiple sclerosis).
- diagnosed with metabolic disorders (e.g. osteomalacia), which may impair bone metabolism.
- diagnosed systemic disease that would affect their welfare or the overall outcome of study (i.e. Paget's disease, renal osteodystrophy)
- immunologically suppressed.
- receiving systemic steroid therapy, excluding inhalers, within 3 months prior to surgery.
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- diagnosed Charcot's disease, metastatic or neoplastic disease.
- evidence of active infections that may spread to other areas of the body (e.g. osteomyelitis, pyogenic infection of the hip joint, overt infection, untreated urinary tract infection, etc.).
- presence of a previous prosthetic hip replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.) in the hip joint to be operated.
- previous Girdlestone procedure (resection arthroplasty) or surgical fusion of the hip to be operated.
- diagnosed with systemic lupus erythematosus, pigmented villonodular synovitis, juvenile rheumatoid arthritis or other diagnoses with autoimmune etiology.
- diagnosed with osteoporosis or as evidenced on a DEXA scan for males over 75 or females over 65 years of age (within the last 12 months).
- require structural bone grafts in order to support the prosthetic component(s) or to shape the bone to receive the implant(s).
- have acute femoral neck fracture or hip fractures.
- have an above the knee amputation of the contralateral and/or ipsilateral leg.
- have an existing total hip arthroplasty in the contralateral hip with a pain rating of 3 or more on a scale of 0 to 10, where 0 is "no pain" and 10 is "severe pain".
- have had a total hip arthroplasty in the contralateral hip within the past 12 months.
- have previously received a metal-on-metal hip arthroplasty.
- have a highly communicable disease or diseases that may limit follow-up (e.g. immunocompromised conditions, hepatitis, active tuberculosis, etc.).
- have any known sensitivity to device material.
- Females who are pregnant.
- Patients who are prisoners.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
Resurgens Orthopaedics
Austell, Georgia, 30106
OrthoCarolina Hip & Knee Center
Charlotte, North Carolina, 28207
Connecticut Joint Replacement Institute (CJRI)
Hartford, Connecticut, 06105
Memorial Bone & Joint
Houston, Texas, 77043
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Arkansas Specialty Orthopaedics
Little Rock, Arkansas, 72205
Denver Hip and Knee, Inc.
Parker, Colorado, 80134
Florida Orthopaedic Institute
Tampa, Florida, 33609
FMC Orthopedic Division
Tampa, Florida, 33613
United Kingdom1 site
Elective Orthopaedic Centre
Epsom, Surrey, KT18 7EG
About this study
Official title: Phase 3 Randomized Controlled Study to Demonstrate Safety and Effectiveness of the BIOLOX Delta CoC THR System
To demonstrate the safety and effectiveness of the Trinity™ BIOLOX delta™ Ceramic-on-Ceramic Total Hip System in comparison to the Trinity™ Acetabular Hip System,which is FDA cleared for use in the U.S. The comparison will be based upon clinical success at the Month 24 endpoint.
Read the detailed description
The clinical research results for the Trinity™ BIOLOX delta™ Ceramic-on-Ceramic Total Hip System will be compared to the control device
Clinical success is based upon Harris Hip Scores to evaluate functional status, adverse events, radiological assessments and no device failure (defined as removal, replacement, or modification of any device component).
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, CDH
- Being tested
- Trinity CoC Total Hip System, Trinity Ceramic-on-Poly THR
- Keywords
- osteoarthritis, avascular necrosis, rheumatoid arthritis, correction of functional deformity, dysplasia of the hip
- Medical subject headings
- Osteoarthritis, Osteonecrosis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trinity CoC Total Hip SystemDevice
total hip replacement with a ceramic femoral head which moves on a ceramic acetabular cup liner
Trinity Ceramic-on-Poly THRDevice
total hip replacement with a ceramic femoral head which moves on a highly cross-linked ultra high molecular weight polyethylene acetabular cup liner
| Study group | Role | What they receive |
|---|---|---|
| Trinity CoC Total Hip System | Experimental | total hip replacement with a ceramic femoral head and ceramic acetabular cup liner Receives: Device: Trinity CoC Total Hip System |
| Trinity Ceramic-on-Poly THR | Active comparator | total hip replacement with a ceramic femoral head and polyethylene acetabular cup liner Receives: Device: Trinity Ceramic-on-Poly THR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Clinical Success
- HHS ≥ 80 at Month 24 (good/excellent)
- No serious, definitely device related complications with onset on or prior to Month 24
- No radiographic failure at Month 24
- No removal, replacement, or modification of any component on or prior to Month 24.
Measured: 24 months post-operative
Secondary outcomes (5)
HHS
- Individual components of the Harris Hip Score (total score, pain and function).
Measured: 24 months post-operative
HOOS score
Hip injury and Osteoarthritis Outcome Score (HOOS).
Measured: 24 months
Subjective pain
VAS pain score
Measured: 24 months
survival
Kaplan-Meier survival curve
Measured: 24 months
adverse events
Summary of device-related complications
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2013 (estimated)
- Study startDec 2012
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (estimated)
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corin
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kathy Trier, Ph.D., Study director, Corin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01921309
- Sponsor's protocol ID
- G120038
- Other IDs
- #G120038
- Status last verified
- Jul 2020
- First submitted
- 10 Jun 2013
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Randomized Controlled Study to Demonstrate Safety and Effectiveness of the BIOLOX Delta CoC THR System
- ClinicalTrials.gov ID
- NCT01921309
- Acronym / sponsor ID
- G120038
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, CDH
- Keywords
- osteoarthritis, avascular necrosis, rheumatoid arthritis, correction of functional deformity, dysplasia of the hip
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 342 participants (actual)
- Lead sponsor
- CorinIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 13 Aug 2013 (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.
To demonstrate the safety and effectiveness of the Trinity™ BIOLOX delta™ Ceramic-on-Ceramic Total Hip System in comparison to the Trinity™ Acetabular Hip System,which is FDA cleared for use in the U.S. The comparison will be based upon clinical success at the Month 24 endpoint.
Detailed description
The clinical research results for the Trinity™ BIOLOX delta™ Ceramic-on-Ceramic Total Hip System will be compared to the control device
Clinical success is based upon Harris Hip Scores to evaluate functional status, adverse events, radiological assessments and no device failure (defined as removal, replacement, or modification of any device component).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trinity CoC Total Hip System | Experimental | Device: Trinity CoC Total Hip Systemtotal hip replacement with a ceramic femoral head and ceramic acetabular cup liner |
| Trinity Ceramic-on-Poly THR | Active comparator | Device: Trinity Ceramic-on-Poly THRtotal hip replacement with a ceramic femoral head and polyethylene acetabular cup liner |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- preoperative Harris Hip Score of ≤ 70.
- preoperative Harris Hip Total Pain score of at least moderate.
- diagnosed with non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, rheumatoid arthritis, correction of functional deformity, developmental hip dysplasia (DDH) and congenital hip dysplasia (CDH).
- pain rating of none or slight and are at least 12 months post-operative in the contralateral hip, if applicable.
- have sufficient femoral and acetabular bone stock as determined by a clinician, and are suitable to receive implants as confirmed by x-rays.
Key exclusion criteria (22 listed)
- have a nutritional problem (protein, calorie, or vitamin/mineral deficiency) that may impair wound healing mechanisms as determined by the clinician /investigator.
- have a neurological disorders which may interfere or adversely affect gait, balance, or weight bearing (e.g. muscular dystrophy, multiple sclerosis).
- diagnosed with metabolic disorders (e.g. osteomalacia), which may impair bone metabolism.
- diagnosed systemic disease that would affect their welfare or the overall outcome of study (i.e. Paget's disease, renal osteodystrophy)
- immunologically suppressed.
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 |
|---|---|---|
| Trinity CoC Total Hip Systemtotal hip replacement with a ceramic femoral head which moves on a ceramic acetabular cup liner | Device | Trinity CoC Total Hip System |
| Trinity Ceramic-on-Poly THRtotal hip replacement with a ceramic femoral head which moves on a highly cross-linked ultra high molecular weight polyethylene acetabular cup liner | Device | Trinity Ceramic-on-Poly THR |
Primary outcome
Composite Clinical Success
Time frame: 24 months post-operative
* HHS ≥ 80 at Month 24 (good/excellent) * No serious, definitely device related complications with onset on or prior to Month 24 * No radiographic failure at Month 24 * No removal, replacement, or modification of any component on or prior to Month 24.
5 secondary outcomes
HHS
Time frame: 24 months post-operative
HOOS score
Time frame: 24 months
Subjective pain
Time frame: 24 months
survival
Time frame: 24 months
adverse events
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
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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.
Kathy Trier, Ph.D. study director
Corin
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trinity CoC Total Hip System and Trinity Ceramic-on-Poly THR in people with Osteoarthritis and Avascular Necrosis, run by Corin at 10 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 5 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, 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?
Results are not available in the source record.
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?
Composite Clinical Success (time frame: 24 months post-operative). 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 Mar 2021.