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

Completed · Not applicable

Conditions studied: Tibial Nonunions

In brief

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.

Key facts

Study ID

NCT00679328

Run by

Olympus Biotech Corporation

People needed

122

Starts

1992-02-01

Expected to finish

1999-12-01

Last updated by the study team

2011-06-10

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must show radiographic skeletal maturity
• Documented evidence of previous fracture management
• Nonunion in the tibia and candidate to receive bone autografts and intramedullary (IM) Nail fixation
• Nonunion gap must not exceed half the diameter of the bone at the site of fracture, as assessed radiographically prior to study treatment

You may not qualify if…

• Patients who do not have adequate vascularity to permit healing
• Patients with inadequate skin coverage
• Patients with chronic use of steroidal medications
• Patients with active infection systemically or at the site of nonunion.

Where it is running

• Study site — Mesa, Arizona, United States
• Study site — Modesto, California, United States
• Study site — San Diego, California, United States
• Study site — Stanford, California, United States
• Study site — Denver, Colorado, United States
• Study site — Fort Carson, Colorado, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Detroit, Michigan, United States
• Study site — St Louis, Missouri, United States
• Study site — New York, New York, United States
• Study site — Cleveland, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Providence, Rhode Island, United States
• Study site — Galveston, Texas, United States
• Study site — Lubbock, Texas, United States

Full record on ClinicalTrials.gov

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