dHACM in Lumbar Decompression and Microdiscectomy Surgery



Status:Recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:November 2014
End Date:December 2017
Contact:Oliver C Sax, BA
Email:SaxO@HSS.EDU
Phone:646-714-6516

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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

The present study investigates the product dHACM, which is unique in that it utilizes an
amniotic membrane that has anti-scarring and anti-keloid formation properties. dHACM also
contains growth factors that promote healing. The growth factors present in dHACM are
Epidermal Growth Factor (EGF), Transforming Growth Factor Beta (TGF-β), Fibroblast Growth
Factor (FGF), and Platelet Derived Growth Factors (PDGF) A&B. These growth factors may play
a role in diminishing EF and have a positive effect on patient treatment outcomes.


Inclusion Criteria:

- Patients over 18 years of age

- 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

- Ability to provide full written consent

Exclusion Criteria:

- Patients under the age 18 years of age

- 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.

- Patient allergic to aminoglycosides

- 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

- Patients with 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 an MRI

- Patients unwilling or unable to return for routine follow-up or complete outcome
instruments at the specified timepoints pre-and post-operatively
We found this trial at
1
site
535 E 70th St
New York, New York 10021
(212) 606-1000
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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mi
from
New York, NY
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