Trinity™ BIOLOX Delta™ CoC THR Multi-center Study

Status:Active, not recruiting
Conditions:Arthritis, Osteoarthritis (OA), Rheumatoid Arthritis, Orthopedic
Therapuetic Areas:Rheumatology, Orthopedics / Podiatry
Age Range:18 - 80
Start Date:December 2012
End Date:November 2020

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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.

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).

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

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

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.
We found this trial at
Hartford, Connecticut 06105
Principal Investigator: John Keggi, MD
Phone: 203-598-0700
Hartford, CT
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13020 N Telecom Pkwy
Tampa, Florida 33637
Principal Investigator: David Watson, M.D.
Phone: 813-558-6834
Tampa, FL
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Austell, Georgia 30106
Principal Investigator: Freddy A Achecar, M.D.
Phone: 770-944-1100
Austell, GA
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Charlotte, North Carolina 28207
Principal Investigator: John Masonis, M.D.
Phone: 704-323-2269
Charlotte, NC
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Epsom, Surrey
Principal Investigator: Andrew Cobb, M.D.
Phone: +44 (0) 1372 735424
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Houston, Texas 77024
Principal Investigator: Stefan Kreuzer, M.D.
Phone: 713-486-3925
Houston, TX
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Jacksonville, Florida 32216
Principal Investigator: Courtney Sherman, M.D.
Phone: 904-953-8354
Jacksonville, FL
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Little Rock, Arkansas 72205
Principal Investigator: C. Lowry Barnes, M.D.
Phone: 501-246-4439
Little Rock, AR
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Parker, Colorado 80134
Principal Investigator: Derek Johnson, M.D.
Phone: 303-250-3828
Parker, CO
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Tampa, Florida 33613
Principal Investigator: Stephen J. Raterman, M.D.
Phone: 813-979-0440
Tampa, FL
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