Trinity™ BIOLOX Delta™ CoC THR Multi-center Study

• Sponsor: Corin
• Information provided by (Responsible Party): Corin

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Osteoarthritis; Avascular Necrosis; Rheumatoid Arthritis; CDH	Device: Trinity CoC Total Hip System; Device: Trinity Ceramic-on-Poly THR	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 342 participants
• 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
• Study Start Date: December 2012
• Estimated Primary Completion Date: August 2020
• Estimated Study Completion Date: November 2020

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. HHS [ Time Frame: 24 months post-operative ]
   • Individual components of the Harris Hip Score (total score, pain and function).
2. HOOS score [ Time Frame: 24 months ]
   Hip injury and Osteoarthritis Outcome Score (HOOS).
3. Subjective pain [ Time Frame: 24 months ]
   VAS pain score
4. survival [ Time Frame: 24 months ]
   Kaplan-Meier survival curve
5. adverse events [ Time Frame: 24 months ]
   Summary of device-related complications

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• 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

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

• Responsible Party: Corin
• ClinicalTrials.gov Identifier: NCT01921309 History of Changes
• Other Study ID Numbers: G120038; #G120038 ( Other Identifier: IDE approved by CDRH )
• First Posted: August 13, 2013
• Last Update Posted: November 21, 2018
• Last Verified: November 2018

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