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dHACM in Lumbar Decompression and Microdiscectomy Surgery

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ClinicalTrials.gov Identifier: NCT02300909
Recruitment Status : Completed
First Posted : November 25, 2014
Last Update Posted : August 23, 2018
Sponsor:
Collaborator:
Hospital for Special Surgery, New York
Information provided by (Responsible Party):
MiMedx Group, Inc.

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.

Condition or disease Intervention/treatment Phase
Scarring Spinal Stenosis Herniated Disc Procedure: Lumbar Decompression Surgery Procedure: Microdiscectomy Surgery Other: Dehydrated Human Amnion/Chorion Membrane (dHACM) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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 Start Date : November 2014
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Arm Intervention/treatment
Experimental: dHACM
Lumbar Decompression Surgery or Microdiscectomy Surgery with Application of Dehydrated Human Amnion/Chorion Membrane (dHACM)
Procedure: Lumbar Decompression Surgery
Lumbar Decompression Surgery

Procedure: Microdiscectomy Surgery
Microdiscectomy Surgery

Other: Dehydrated Human Amnion/Chorion Membrane (dHACM)
Application of Dehydrated Human Amnion/Chorion Membrane (dHACM)

Surgery without dHACM
Control Group - Lumbar Decompression Surgery or Microdiscectomy Surgery without application of dHACM
Procedure: Lumbar Decompression Surgery
Lumbar Decompression Surgery

Procedure: Microdiscectomy Surgery
Microdiscectomy Surgery




Primary Outcome Measures :
  1. Oswestry Disability Index [ Time Frame: 2 years ]
    Patient Functional Outcomes Questionnaire


Secondary Outcome Measures :
  1. Re-operation (Number of patients having re-operation during study) [ Time Frame: 2 years ]
    Number of patients having re-operation during study

  2. Scar formation in revision cases [ Time Frame: 2 years ]
    Dissection of scar formation required at re-operation

  3. Quality of Life (VAS Pain) [ Time Frame: 2 years ]
    VAS Pain

  4. Quality of Life (SF-36) [ Time Frame: 2 years ]
    SF-36

  5. Quality of Life [ Time Frame: 2 years ]
    HSS Lumbar Expectations Survey


Other Outcome Measures:
  1. MRI findings in first 20 patients [ Time Frame: 3 months post-op ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300909


Locations
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United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
MiMedx Group, Inc.
Hospital for Special Surgery, New York
Investigators
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Principal Investigator: Alexander Hughes, MD Hospital for Special Surgery, New York

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Responsible Party: MiMedx Group, Inc.
ClinicalTrials.gov Identifier: NCT02300909     History of Changes
Obsolete Identifiers: NCT02380456
Other Study ID Numbers: AFLUD001
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
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Spinal Stenosis
Intervertebral Disc Displacement
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Hernia
Pathological Conditions, Anatomical