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Trinity™ BIOLOX Delta™ CoC THR Multi-center Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by Corin
Information provided by (Responsible Party):
Corin Identifier:
First received: June 10, 2013
Last updated: October 6, 2015
Last verified: October 2015
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.

Condition Intervention Phase
Avascular Necrosis
Rheumatoid Arthritis
Device: Trinity CoC Total Hip System
Device: Trinity Ceramic-on-Poly THR
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Phase 3 Randomized Controlled Study to Demonstrate Safety and Effectiveness of the BIOLOX Delta CoC THR System

Resource links provided by NLM:

Further study details as provided by Corin:

Primary Outcome Measures:
  • Composite Clinical Success [ Time Frame: 24 months post-operative ] [ Designated as safety issue: Yes ]
    • 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.

Secondary Outcome Measures:
  • HHS [ Time Frame: 24 months post-operative ] [ Designated as safety issue: No ]
    • Individual components of the Harris Hip Score (total score, pain and function).

  • HOOS score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Hip injury and Osteoarthritis Outcome Score (HOOS).

  • pain [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    VAS pain score

  • survival [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Kaplan-Meier survival curve

  • adverse events [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Summary of device-related complications

Estimated Enrollment: 402
Study Start Date: December 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trinity CoC Total Hip System
total hip replacement with a ceramic femoral head and ceramic acetabular cup liner
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
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

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).


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. preoperative Harris Hip Score of ≤ 70.
  2. preoperative Harris Hip Total Pain score of at least moderate.
  3. 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).
  4. pain rating of none or slight and are at least 12 months post-operative in the contralateral hip, if applicable.
  5. 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:

  1. have a nutritional problem (protein, calorie, or vitamin/mineral deficiency) that may impair wound healing mechanisms as determined by the clinician /investigator.
  2. have a neurological disorders which may interfere or adversely affect gait, balance, or weight bearing (e.g. muscular dystrophy, multiple sclerosis).
  3. diagnosed with metabolic disorders (e.g. osteomalacia), which may impair bone metabolism.
  4. diagnosed systemic disease that would affect their welfare or the overall outcome of study (i.e. Paget's disease, renal osteodystrophy)
  5. immunologically suppressed.
  6. receiving systemic steroid therapy, excluding inhalers, within 3 months prior to surgery.
  7. diagnosed Charcot's disease, metastatic or neoplastic disease.
  8. 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.).
  9. presence of a previous prosthetic hip replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.) in the hip joint to be operated.
  10. previous Girdlestone procedure (resection arthroplasty) or surgical fusion of the hip to be operated.
  11. diagnosed with systemic lupus erythematosus, pigmented villonodular synovitis, juvenile rheumatoid arthritis or other diagnoses with autoimmune etiology.
  12. 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).
  13. require structural bone grafts in order to support the prosthetic component(s) or to shape the bone to receive the implant(s).
  14. have acute femoral neck fracture or hip fractures.
  15. have an above the knee amputation of the contralateral and/or ipsilateral leg.
  16. 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".
  17. have had a total hip arthroplasty in the contralateral hip within the past 12 months.
  18. have previously received a metal-on-metal hip arthroplasty.
  19. have a highly communicable disease or diseases that may limit follow-up (e.g. immunocompromised conditions, hepatitis, active tuberculosis, etc.).
  20. have any known sensitivity to device material.
  21. Females who are pregnant.
  22. Patients who are prisoners.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01921309

Contact: Weslynn Baird 813-977-4469
Contact: Katie Kolb 813-977-4469

United States, Arkansas
Arkansas Specialty Orthopaedics Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Becky Wilson    501-246-4439   
Principal Investigator: C. Lowry Barnes, M.D.         
Sub-Investigator: Paul Edwards, M.D.         
Sub-Investigator: Gordon Newbern, M.D.         
United States, Colorado
Denver Hip and Knee, Inc. Recruiting
Parker, Colorado, United States, 80134
Contact: Amy Gridley    303-250-3828   
Principal Investigator: Derek Johnson, M.D.         
United States, Connecticut
Connecticut Joint Replacement Institute (CJRI) Recruiting
Hartford, Connecticut, United States, 06105
Contact: Gina Panek    203-598-0700   
Principal Investigator: John Keggi, MD         
United States, Florida
Mayo Clinic Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Contact: Shari Kazmerchak    904-953-8354   
Principal Investigator: Courtney Sherman, M.D.         
Sub-Investigator: Kurt Blasser, M.D.         
Florida Orthopaedic Institute Recruiting
Tampa, Florida, United States, 33609
Contact: Sherri Leverett    813-558-6834   
Principal Investigator: David Watson, M.D.         
Sub-Investigator: Michael Miranda, D.O.         
FMC Orthopedic Division Recruiting
Tampa, Florida, United States, 33613
Contact: Jessica Sommers    813-979-0440   
Principal Investigator: Stephen J. Raterman, M.D.         
United States, Georgia
Resurgens Orthopaedics Recruiting
Austell, Georgia, United States, 30106
Contact: April Skinner    770-944-1100   
Principal Investigator: Freddy A Achecar, M.D.         
United States, North Carolina
OrthoCarolina Hip & Knee Center Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Barbara Davis    704-323-2269   
Principal Investigator: John Masonis, M.D.         
United States, Texas
Memorial Bone & Joint Recruiting
Houston, Texas, United States, 77043
Contact: Ashish Arya    713-486-3925   
Principal Investigator: Stefan Kreuzer, M.D.         
Sub-Investigator: Adam Freedhand, MD         
United Kingdom
Elective Orthopaedic Centre Recruiting
Epsom, Surrey, United Kingdom, KT18 7EG
Contact: Jas Curtis    +44 (0) 1372 735424    Jas.curtis@eoc.nhs.rk   
Principal Investigator: Andrew Cobb, M.D.         
Sponsors and Collaborators
Study Director: Kathy Trier, Ph.D. Corin
  More Information

Additional Information:
Responsible Party: Corin Identifier: NCT01921309     History of Changes
Other Study ID Numbers: G120038  #G120038 
Study First Received: June 10, 2013
Last Updated: October 6, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Corin:
avascular necrosis
rheumatoid arthritis
correction of functional deformity
dysplasia of the hip

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Bone Diseases processed this record on October 25, 2016