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

Not Applicable

Completed

• Conditions: Tibial Nonunions
• Interventions: Device: Surgical implantation of OP-1 device or autograft bone graft material

• Registration Number: NCT00679328
• Lead Sponsor: Olympus Biotech Corporation

Brief 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.

Study Timeline

• Study Start: 1992-02
• Primary Completion: 1996-08
• Study Completion: 1999-12
• Study First Submitted: 2008-05-13
• Study First Submitted QC: 2008-05-14
• Study First Posted: 2008-05-16
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-09
• Last Update Posted: 2011-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Surgical implantation of OP-1 device or autograft bone graft material	Surgical implantation of OP-1
2	Surgical implantation of OP-1 device or autograft bone graft material	Surgical implantation of bone graft material

Primary Outcome Measures

Name	Time	Method
No further retreatment of the surgical site, function and pain at the site of the nonunion, evidence of bridging.	3, 6, 9, 12, 24 months

Secondary Outcome Measures

Name	Time	Method
Medical events, treatment related events, laboratory tests, medication use.	3, 6, 9, 12, 24 months