Trinity™ BIOLOX Delta™ CoC THR Multi-center Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01921309 |
Recruitment Status :
Active, not recruiting
First Posted : August 13, 2013
Last Update Posted : October 27, 2020
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Condition or disease | Intervention/treatment | Phase |
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Osteoarthritis Avascular Necrosis Rheumatoid Arthritis CDH | Device: Trinity CoC Total Hip System Device: Trinity Ceramic-on-Poly THR | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 342 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Phase 3 Randomized Controlled Study to Demonstrate Safety and Effectiveness of the BIOLOX Delta CoC THR System |
Study Start Date : | December 2012 |
Estimated Primary Completion Date : | March 2021 |
Estimated Study Completion Date : | March 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Trinity CoC Total Hip System
total hip replacement with a ceramic femoral head and ceramic acetabular cup liner
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Device: Trinity CoC Total Hip System
total hip replacement with a ceramic femoral head which moves on a ceramic acetabular cup liner |
Active Comparator: Trinity Ceramic-on-Poly THR
total hip replacement with a ceramic femoral head and polyethylene acetabular cup liner
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Device: Trinity Ceramic-on-Poly THR
total hip replacement with a ceramic femoral head which moves on a highly cross-linked ultra high molecular weight polyethylene acetabular cup liner |
- 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.
- HHS [ Time Frame: 24 months post-operative ]• Individual components of the Harris Hip Score (total score, pain and function).
- HOOS score [ Time Frame: 24 months ]Hip injury and Osteoarthritis Outcome Score (HOOS).
- Subjective pain [ Time Frame: 24 months ]VAS pain score
- survival [ Time Frame: 24 months ]Kaplan-Meier survival curve
- adverse events [ Time Frame: 24 months ]Summary of device-related complications

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01921309
United States, Arkansas | |
Arkansas Specialty Orthopaedics | |
Little Rock, Arkansas, United States, 72205 | |
United States, Colorado | |
Denver Hip and Knee, Inc. | |
Parker, Colorado, United States, 80134 | |
United States, Connecticut | |
Connecticut Joint Replacement Institute (CJRI) | |
Hartford, Connecticut, United States, 06105 | |
United States, Florida | |
Mayo Clinic Jacksonville | |
Jacksonville, Florida, United States, 32224 | |
Florida Orthopaedic Institute | |
Tampa, Florida, United States, 33609 | |
FMC Orthopedic Division | |
Tampa, Florida, United States, 33613 | |
United States, Georgia | |
Resurgens Orthopaedics | |
Austell, Georgia, United States, 30106 | |
United States, North Carolina | |
OrthoCarolina Hip & Knee Center | |
Charlotte, North Carolina, United States, 28207 | |
United States, Texas | |
Memorial Bone & Joint | |
Houston, Texas, United States, 77043 | |
United Kingdom | |
Elective Orthopaedic Centre | |
Epsom, Surrey, United Kingdom, KT18 7EG |
Study Director: | Kathy Trier, Ph.D. | Corin |
Responsible Party: | Corin |
ClinicalTrials.gov Identifier: | NCT01921309 |
Other Study ID Numbers: |
G120038 #G120038 ( Other Identifier: IDE approved by CDRH ) |
First Posted: | August 13, 2013 Key Record Dates |
Last Update Posted: | October 27, 2020 |
Last Verified: | July 2020 |
osteoarthritis avascular necrosis rheumatoid arthritis correction of functional deformity dysplasia of the hip |
Arthritis Osteoarthritis Arthritis, Rheumatoid Necrosis Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes |