Status:
UNKNOWN
Trinity™ BIOLOX Delta™ CoC THR Multi-center Study
Lead Sponsor:
Corin
Conditions:
Osteoarthritis
Avascular Necrosis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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....
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 fu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
342 Patients enrolled
Trial Details
Trial ID
NCT01921309
Start Date
December 1 2012
End Date
December 1 2021
Last Update
March 11 2021
Active Locations (10)
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1
Arkansas Specialty Orthopaedics
Little Rock, Arkansas, United States, 72205
2
Denver Hip and Knee, Inc.
Parker, Colorado, United States, 80134
3
Connecticut Joint Replacement Institute (CJRI)
Hartford, Connecticut, United States, 06105
4
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224