This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Trinity™ BIOLOX Delta™ CoC THR Multi-center Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Corin
ClinicalTrials.gov Identifier:
NCT01921309
First received: June 10, 2013
Last updated: January 5, 2017
Last verified: January 2017
  Purpose
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
Osteoarthritis Avascular Necrosis Rheumatoid Arthritis CDH Device: Trinity CoC Total Hip System Device: Trinity Ceramic-on-Poly THR Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Corin:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).

  • 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


Enrollment: 342
Study Start Date: December 2012
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01921309

Locations
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
Sponsors and Collaborators
Corin
Investigators
Study Director: Kathy Trier, Ph.D. Corin
  More Information

Additional Information:
Responsible Party: Corin
ClinicalTrials.gov Identifier: NCT01921309     History of Changes
Other Study ID Numbers: G120038
#G120038 ( Other Identifier: IDE approved by CDRH )
Study First Received: June 10, 2013
Last Updated: January 5, 2017

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

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Arthritis, Rheumatoid
Necrosis
Osteonecrosis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Bone Diseases

ClinicalTrials.gov processed this record on September 20, 2017