Clinical trial NCT01921309: Trinity™ BIOLOX Delta™ CoC THR Multi-center Study
Official title: Phase 3 Randomized Controlled Study to Demonstrate Safety and Effectiveness of the BIOLOX Delta CoC THR System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis
Avascular Necrosis
Rheumatoid Arthritis
CDH
Keywords: osteoarthritis
avascular necrosis
rheumatoid arthritis
correction of functional deformity
dysplasia of the hip
Lead sponsor: Corin
Sponsor class: INDUSTRY
First posted: 2013-08-13
Enrollment: 342
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.S. The comparison will be based upon clinical success at the Month 24 endpoint.

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 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.

Primary outcomes:
measure: Composite Clinical Success
timeFrame: 24 months post-operative
Secondary outcomes:
measure: HHS
timeFrame: 24 months post-operative
measure: HOOS score
timeFrame: 24 months
measure: Subjective pain
timeFrame: 24 months
measure: survival
timeFrame: 24 months
measure: adverse events
timeFrame: 24 months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Specialty Orthopaedics
state: Arkansas
city: Parker
country: United States
facility: Denver Hip and Knee, Inc.
state: Colorado
city: Hartford
country: United States
facility: Connecticut Joint Replacement Institute (CJRI)
state: Connecticut
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Tampa
country: United States
facility: Florida Orthopaedic Institute
state: Florida
city: Tampa
country: United States
facility: FMC Orthopedic Division
state: Florida
city: Austell
country: United States
facility: Resurgens Orthopaedics
state: Georgia
city: Charlotte
country: United States
facility: OrthoCarolina Hip & Knee Center
state: North Carolina
city: Houston
country: United States
facility: Memorial Bone & Joint
state: Texas
city: Epsom
country: United Kingdom
facility: Elective Orthopaedic Centre
state: Surrey
Study officials:
affiliation: Corin
name: Kathy Trier, Ph.D.
role: STUDY_DIRECTOR
References: