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

Olympus

Status: Completed

Conditions: Tibial Nonunions

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00679328

91-01

TR-0056

Details and patient eligibility

About

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.

Full 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.

Enrollment: 122 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

1

Experimental group

Description:

Surgical implantation of OP-1

Treatment:

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

2

Active Comparator group

Description:

Surgical implantation of bone graft material

Treatment:

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