NCT00679328

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

Study #91-01 - A Randomized Study of the Stryker OP Device vs. Bone Autograft for the Treatment of Tibial Nonunions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Olympus Biotech Corporation · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is to evaluate the safety and effectiveness of the OP device for the treatment of nonunion bone fractures and to compare the clinical safety and effectiveness (healing rates) of the OP Device to that of traditional bone autografts to repair nonunions.

Conditions

• Tibial Nonunions

Interventions

Type	Name	Description
DEVICE	Surgical implantation of OP-1 device or autograft bone graft material	Surgical implantation of OP-1 device or autograft bone graft material

Timeline

• Start date: 1992-02-01
• Primary completion: 1996-08-01
• Completion: 1999-12-01
• First posted: 2008-05-16
• Last updated: 2011-06-10

Locations

18 sites across 1 country: United States