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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
122
Surgical implantation of OP-1 device or autograft bone graft material
Unnamed facility
Mesa, Arizona, United States
Unnamed facility
Modesto, California, United States
Unnamed facility
San Diego, California, United States
No further retreatment of the surgical site, function and pain at the site of the nonunion, evidence of bridging.
Time frame: 3, 6, 9, 12, 24 months
Medical events, treatment related events, laboratory tests, medication use.
Time frame: 3, 6, 9, 12, 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Stanford, California, United States
Unnamed facility
Denver, Colorado, United States
Unnamed facility
Fort Carson, Colorado, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
Orlando, Florida, United States
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
New Orleans, Louisiana, United States
...and 8 more locations