dHACM in Lumbar Decompression and Microdiscectomy Surgery
dHACM in Lumbar Decompression and Microdiscectomy Surgery
Prospective evaluation of the safety and efficacy of dHACM on clinical outcomes in lumbar
 laminectomy and microdiscectomy patients as assessed by Oswestry Disability Index.
The objective of this prospective study is to evaluate the safety and efficacy of dHACM on
 clinical outcomes in lumbar laminectomy and microdiscectomy patients randomized to one of two
 groups: 1) without dHACM (control) or 2) dHACM.
Inclusion Criteria:

 1. Are 18 (eighteen) years of age or older at the time of surgery.

 2. Patients with single- or multi-level spinal stenosis undergoing open lumbar
 laminectomy, or patients with single-level herniated nucleus pulposus undergoing
 single-level lumbar microdiscectomy

 3. Are willing and able to return for the scheduled follow-up visits, follow post
 operative instructions and undergo the required radiographic exams for up to 5 time
 points between 4 weeks and 24 months post-surgery (6 weeks ± 2 weeks, 12 weeks ± 2
 weeks, 6 months ±1 month, 1 year±2 months, and 2 years ±2 months post-surgery),
 including one study MRI-scan at 12 weeks ±2 weeks for the first 20 patients enrolled.

 4. Are willing and able to sign study specific informed consent.

 Exclusion Criteria:

 1. Non-English speaking patients

 2. Non-surgical candidate defined as any patient deemed by the surgeon not to be a
 surgical candidate cannot participate for the following reasons: that patient does not
 meet indications for lumbar laminectomy or microdiscectomy surgery, patient has a
 contraindication to surgery such as medical comorbidities, pregnancy, etc.

 3. Allergic to aminoglycoside antibiotics

 4. Is a prisoner

 5. Is involved in worker's compensation or other litigation relative to the spine injury

 6. Has a history of drug or alcohol abuse within the last 12 months

 7. Is currently participating in another drug or device clinical trial

 8. Previous spinal surgery

 9. History of deformity, mechanical instability, or spinal fusion requirement

 10. History of hard- or soft-tissue spinal infection

 11. Has signs or symptoms of any disease, such as autoimmune disease, which could result
 in allograft failure, or has experienced allograft failure in the past

 12. Patients unable to undergo a MRI