Trinity™ BIOLOX Delta™ CoC THR Multi-center Study

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.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis; Rheumatoid Arthritis; Avascular Necrosis; CDH
• Intervention / Treatment: Device: Trinity CoC Total Hip System; Device: Trinity Ceramic-on-Poly THR

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 Type: Interventional
• Enrollment (Actual): 342
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Surrey
    • Epsom, Surrey, United Kingdom, KT18 7EG
      • Elective Orthopaedic Centre
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Arkansas Specialty Orthopaedics
  • Colorado
    • Parker, Colorado, United States, 80134
      • Denver Hip and Knee, Inc.
  • Connecticut
    • Hartford, Connecticut, United States, 06105
      • Connecticut Joint Replacement Institute (CJRI)
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Jacksonville
    • Tampa, Florida, United States, 33609
      • Florida Orthopaedic Institute
    • Tampa, Florida, United States, 33613
      • FMC Orthopedic Division
  • Georgia
    • Austell, Georgia, United States, 30106
      • Resurgens Orthopaedics
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • OrthoCarolina Hip & Knee Center
  • Texas
    • Houston, Texas, United States, 77043
      • Memorial Bone & Joint

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Clinical Success	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.	24 months post-operative

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Corin
• Investigators: Study Director: Kathy Trier, Ph.D., Corin

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: June 10, 2013
• First Submitted That Met QC Criteria: August 9, 2013
• First Posted (Estimate): August 13, 2013

Study Record Updates

• Last Update Posted (Actual): March 11, 2021
• Last Update Submitted That Met QC Criteria: March 10, 2021
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: osteoarthritis; rheumatoid arthritis; avascular necrosis; correction of functional deformity; dysplasia of the hip
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Osteoarthritis; Necrosis
• Other Study ID Numbers: G120038; #G120038 (Other Identifier: IDE approved by CDRH)