Clinical trial NCT02300909: dHACM in Lumbar Decompression and Microdiscectomy Surgery
Official title: A Randomized, Single Blind, Controlled Trial of Clinical Outcomes of Dehydrated Human Amnion/Chorion Membrane (dHACM) in Lumbar Decompression and Microdiscectomy Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scarring
Spinal Stenosis
Herniated Disc
Lead sponsor: MiMedx Group, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Hospital for Special Surgery, New York
First posted: 2014-11-25
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Oswestry Disability Index
timeFrame: 2 years
Secondary outcomes:
measure: Re-operation (Number of patients having re-operation during study)
timeFrame: 2 years
measure: Scar formation in revision cases
timeFrame: 2 years
measure: Quality of Life (VAS Pain)
timeFrame: 2 years
measure: Quality of Life (SF-36)
timeFrame: 2 years
measure: Quality of Life
timeFrame: 2 years
Other outcomes:
measure: MRI findings in first 20 patients
timeFrame: 3 months post-op
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Alexander Hughes, MD
role: PRINCIPAL_INVESTIGATOR
References: