dHACM in Lumbar Decompression and Microdiscectomy Surgery

Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02380456
• Other study ID #: 2014-119
• Status: Recruiting
• Phase: N/A
• First received: February 26, 2015
• Last updated: March 2, 2015
• Start date: November 2014
• Est. completion date: December 2017

Study information

• Verified date: March 2015
• Source: Hospital for Special Surgery, New York
• Contact: Oliver C Sax, BA
• Phone: 646-714-6516
• Email: SaxO[@]HSS.EDU
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 224
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Herniated Disc
• Spinal Stenosis

Intervention

Other:
• dHACM
dHACM is a composite of dehydrated amniotic membrane graft layers designed to be a natural barrier that protects the collagen matrix and optimize surgical performance. The product is processed from human tissue according to the American Association of Tissue Banks (AATB) standards and is regulated as a tissue product under Section 361 of the Public Health Service Act.

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Alexander P. Hughes, MD	MiMedx Group, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oswestry Disability Index		2 years	No
Secondary	Visual Analog Scale (Back and Leg Pain)		2 years	No
Secondary	SF-36		2 years	No
Secondary	Hospital for Special Surgery Lumbar Spine Expectations Survey		2 years	No
Secondary	Safety Evaluations (Adverse events including intra- and post-operative complications, infections)	Adverse events including intra- and post-operative complications, infections	2 years	No
Secondary	Revision Surgery or Re-operation		2 years	No
Secondary	Disc Re-herniation		2 years	No
Secondary	MRI Findings of Major Pathology (20 Pilot Patients)		3 months post-operatively	No