Trinity™ BIOLOX Delta™ CoC THR Multi-center Study

Not Applicable

• Conditions: Avascular Necrosis; Osteoarthritis; CDH; Rheumatoid Arthritis
• Interventions: Device: Trinity CoC Total Hip System; Device: Trinity Ceramic-on-Poly THR

• Registration Number: NCT01921309
• Lead Sponsor: Corin

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).

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-06-10
• Study First Submitted QC: 2013-08-09
• Study First Posted: 2013-08-13
• Status Verified: 2020-07
• Last Update Submitted: 2021-03-10
• Last Update Posted: 2021-03-11
• Primary Completion: 2021-09
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 342

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Trinity CoC Total Hip System	Trinity CoC Total Hip System	total hip replacement with a ceramic femoral head and ceramic acetabular cup liner
Trinity Ceramic-on-Poly THR	Trinity Ceramic-on-Poly THR	total hip replacement with a ceramic femoral head and polyethylene acetabular cup liner

Primary Outcome Measures

Name	Time	Method
Composite Clinical Success	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

Name	Time	Method
HHS	24 months post-operative	• Individual components of the Harris Hip Score (total score, pain and function).
HOOS score	24 months	Hip injury and Osteoarthritis Outcome Score (HOOS).
Subjective pain	24 months	VAS pain score
survival	24 months	Kaplan-Meier survival curve
adverse events	24 months	Summary of device-related complications

Trial Locations

Locations (10)

Denver Hip and Knee, Inc.; 🇺🇸 Parker, Colorado, United States

Arkansas Specialty Orthopaedics; 🇺🇸 Little Rock, Arkansas, United States

Florida Orthopaedic Institute; 🇺🇸 Tampa, Florida, United States

Connecticut Joint Replacement Institute (CJRI); 🇺🇸 Hartford, Connecticut, United States

OrthoCarolina Hip & Knee Center; 🇺🇸 Charlotte, North Carolina, United States

Elective Orthopaedic Centre; 🇬🇧 Epsom, Surrey, United Kingdom

Memorial Bone & Joint; 🇺🇸 Houston, Texas, United States

Mayo Clinic Jacksonville; 🇺🇸 Jacksonville, Florida, United States

FMC Orthopedic Division; 🇺🇸 Tampa, Florida, United States

Resurgens Orthopaedics; 🇺🇸 Austell, Georgia, United States