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 |
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.
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
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
Click here to add this to my saved trials
