This study will explore the use of recombinant OP-1 in conjunction with surgical treatment of single-level TLIF of the lumbar spine.
This pilot study is a randomized, multi-center, prospective, controlled study of the efficacy and safety of OP-1 Putty Spinal System in patients requiring a single level transforaminal interbody fusion of the lumbar spine (TLIF).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
TLIF with an AVS™TL PEEK Spacer System and XIA® Spinal System using either OP-1 Putty and/or Autograft.
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Los Angeles, California, United States
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San Diego, California, United States
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Durango, Colorado, United States
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Boston, Massachusetts, United States
Pain and function as measured by an Oswestry Disability Index, no revisions, removals or supplemental fixations, fusion success, defined as radiographic evidence of fusion, maintenance or improvement in lower extremity neurologic function
Time frame: 12 and 24 months post intervention
Quality of life determinations (SF-36), pain assessments (VAS), work status and assessment of additional radiographic parameters
Time frame: 12 and 24 months post intervention
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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Southfield, Michigan, United States
Unnamed facility
Minneapolis, Minnesota, United States
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Omaha, Nebraska, United States
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Charlotte, North Carolina, United States
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Philadelphia, Pennsylvania, United States
Unnamed facility
Temple, Texas, United States