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Trinity™ BIOLOX Delta™ CoC THR Multi-center Study

NCT01921309 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 342

Last updated 2021-03-11

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Corin

    lead INDUSTRY

Principal Investigators

  • Kathy Trier, Ph.D. · Corin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2021-09-30
Completion
2021-12-31

Countries

  • United States
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01921309 on ClinicalTrials.gov