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

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.

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.

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.