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About
The primary objective of this clinical trial is to evaluate the success rates of Actifuse ABX and INFUSE in achieving bone fusion.
The secondary objective of this clinical trial is to assess clinical outcome measurements.
Enrollment
Sex
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Volunteers
Inclusion criteria
Has degenerative disc disease of the lumbar spine as indicated by back pain of discogenic/degenerative origin, with or without leg pain, and has one or more of the following conditions as documented by plain X-rays, CT scan or MRI scan:
Has a preoperative Oswestry Back Disability Score of 30 or more.
Aged 18 to 75 years and skeletally mature at time of surgery.
Has not responded to non-operative treatment (e.g., bed rest, physical therapy, medications and/or spinal injections) for a period of six months.
If of childbearing potential, patient is non-pregnant, non-nursing and agrees not to become pregnant for one year following surgery.
Is willing to and able to comply with the study plan and able to understand and sign the Patient Informed Consent Form.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
20 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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