OP Device vs. Bone Autograft for the Treatment of Tibial Nonunions
NCT ID: NCT00679328
Last Updated: 2011-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
122 participants
INTERVENTIONAL
1992-02-29
1999-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Surgical implantation of OP-1
Surgical implantation of OP-1 device or autograft bone graft material
Surgical implantation of OP-1 device or autograft bone graft material
2
Surgical implantation of bone graft material
Surgical implantation of OP-1 device or autograft bone graft material
Surgical implantation of OP-1 device or autograft bone graft material
Interventions
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Surgical implantation of OP-1 device or autograft bone graft material
Surgical implantation of OP-1 device or autograft bone graft material
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
85 Years
ALL
No
Sponsors
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Olympus Biotech Corporation
INDUSTRY
Responsible Party
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Olympus Biotech
Locations
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Mesa, Arizona, United States
Modesto, California, United States
San Diego, California, United States
Stanford, California, United States
Denver, Colorado, United States
Fort Carson, Colorado, United States
Miami, Florida, United States
Orlando, Florida, United States
Atlanta, Georgia, United States
New Orleans, Louisiana, United States
Detroit, Michigan, United States
St Louis, Missouri, United States
New York, New York, United States
Cleveland, Ohio, United States
Philadelphia, Pennsylvania, United States
Providence, Rhode Island, United States
Galveston, Texas, United States
Lubbock, Texas, United States
Countries
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Other Identifiers
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TR-0056
Identifier Type: -
Identifier Source: secondary_id
91-01
Identifier Type: -
Identifier Source: org_study_id
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