Trinity™ BIOLOX Delta™ CoC THR Multi-center Study

Rheumatoid Arthritis Clinical Trial

Official title:

Phase 3 Randomized Controlled Study to Demonstrate Safety and Effectiveness of the BIOLOX Delta CoC THR System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01921309
• Other study ID #: G120038
• Secondary ID: #G120038
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2012
• Est. completion date: December 2021

Study information

• Verified date: July 2020
• Source: Corin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 342
• Est. completion date: December 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Avascular Necrosis
• CDH
• Necrosis
• Osteoarthritis
• Rheumatoid Arthritis

Intervention

Device:
• Trinity CoC Total Hip System
total hip replacement with a ceramic femoral head which moves on a ceramic acetabular cup liner
• 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

Locations

Country	Name	City	State
United Kingdom	Elective Orthopaedic Centre	Epsom	Surrey
United States	Resurgens Orthopaedics	Austell	Georgia
United States	OrthoCarolina Hip & Knee Center	Charlotte	North Carolina
United States	Connecticut Joint Replacement Institute (CJRI)	Hartford	Connecticut
United States	Memorial Bone & Joint	Houston	Texas
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	Arkansas Specialty Orthopaedics	Little Rock	Arkansas
United States	Denver Hip and Knee, Inc.	Parker	Colorado
United States	Florida Orthopaedic Institute	Tampa	Florida
United States	FMC Orthopedic Division	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Corin

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

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