MedTrace Logo

OP Device vs. Bone Autograft for the Treatment of Tibial Nonunions

NCT00679328 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2011-06-10

No results posted yet for this study

Summary

This study is to evaluate the safety and effectiveness of the OP device for the treatment of nonunion bone fractures and to compare the healing rates of the OP Device to that of autograft.

Conditions

  • Tibial Nonunions

Interventions

DEVICE

Surgical implantation of OP-1 device or autograft bone graft material

Surgical implantation of OP-1 device or autograft bone graft material

Sponsors & Collaborators

  • Olympus Biotech Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
1992-02-29
Primary Completion
1996-08-31
Completion
1999-12-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00679328 on ClinicalTrials.gov