dHACM in Lumbar Decompression and Microdiscectomy Surgery

Study Overview
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Brief Summary
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Prospective evaluation of the safety and efficacy of dHACM on clinical outcomes in lumbar laminectomy and microdiscectomy patients as assessed by Oswestry Disability Index.

Detailed Description
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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.

Official Title
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A Randomized, Single Blind, Controlled Trial of Clinical Outcomes of Dehydrated Human Amnion/Chorion Membrane (dHACM) in Lumbar Decompression and Microdiscectomy Surgery

Conditions
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Scarring, Spinal Stenosis, Herniated Disc

Intervention / Treatment
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* Procedure: Lumbar Decompression Surgery
* Procedure: Microdiscectomy Surgery
* Other: Dehydrated Human Amnion/Chorion Membrane (dHACM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are 18 (eighteen) years of age or older at the time of surgery. 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 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. Are willing and able to sign study specific informed consent. Exclusion Criteria: Non-English speaking patients 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. Allergic to aminoglycoside antibiotics Is a prisoner Is involved in worker's compensation or other litigation relative to the spine injury Has a history of drug or alcohol abuse within the last 12 months Is currently participating in another drug or device clinical trial Previous spinal surgery History of deformity, mechanical instability, or spinal fusion requirement History of hard- or soft-tissue spinal infection 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 Patients unable to undergo a MRI

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dHACM<br>Lumbar Decompression Surgery or Microdiscectomy Surgery with Application of Dehydrated Human Amnion/Chorion Membrane (dHACM) | Procedure: Lumbar Decompression Surgery<br>* Lumbar Decompression Surgery<br>Procedure: Microdiscectomy Surgery<br>* Microdiscectomy Surgery<br>Other: Dehydrated Human Amnion/Chorion Membrane (dHACM)<br>* Application of Dehydrated Human Amnion/Chorion Membrane (dHACM)<br>|
| Other: Surgery without dHACM<br>Control Group - Lumbar Decompression Surgery or Microdiscectomy Surgery without application of dHACM | Procedure: Lumbar Decompression Surgery<br>* Lumbar Decompression Surgery<br>Procedure: Microdiscectomy Surgery<br>* Microdiscectomy Surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index | Patient Functional Outcomes Questionnaire | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-operation (Number of patients having re-operation during study) | Number of patients having re-operation during study | 2 years | 
| Scar formation in revision cases | Dissection of scar formation required at re-operation | 2 years | 
| Quality of Life (VAS Pain) | VAS Pain | 2 years | 
| Quality of Life (SF-36) | SF-36 | 2 years | 
| Quality of Life | HSS Lumbar Expectations Survey | 2 years |