NCT01921309

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 342 (actual)
• Sponsor: Corin · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Osteoarthritis
• Avascular Necrosis
• Rheumatoid Arthritis
• CDH

Interventions

Type	Name	Description
DEVICE	Trinity CoC Total Hip System	total hip replacement with a ceramic femoral head which moves on a ceramic 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

Timeline

• Start date: 2012-12-01
• Primary completion: 2021-09-01
• Completion: 2021-12-01
• First posted: 2013-08-13
• Last updated: 2021-03-11

Locations

10 sites across 2 countries: United States, United Kingdom