Tibial Nonunions
Conditions
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.
Interventions
DEVICESurgical implantation of OP-1 device or autograft bone graft material
Surgical implantation of OP-1 device or autograft bone graft material
Sponsors
Olympus Biotech Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Medical events, treatment related events, laboratory tests, medication use. | 3, 6, 9, 12, 24 months |
Countries
United States
Outcome results
None listed