dHACM in Lumbar Decompression and Microdiscectomy Surgery

• Sponsor: MiMedx Group, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02300909
• Collaborator: Hospital for Special Surgery, New York (Other)
• Enrollment: 143
• Location: 1
• Arms: 2
• Duration (Months): 43
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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)	N/A

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.

Study Design

• Study Type: Interventional
• 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: Nov 1, 2014
• Actual Primary Completion Date: Jun 1, 2018
• Actual Study Completion Date: Jun 1, 2018

Arms and Interventions

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)
Other: 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

Outcome Measures

Primary Outcome Measures

1. Oswestry Disability Index [2 years]

   Patient Functional Outcomes Questionnaire

Secondary Outcome Measures

1. Re-operation (Number of patients having re-operation during study) [2 years]

   Number of patients having re-operation during study

2. Scar formation in revision cases [2 years]

   Dissection of scar formation required at re-operation

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

   VAS Pain

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

   SF-36

5. Quality of Life [2 years]

   HSS Lumbar Expectations Survey

Other Outcome Measures

1. MRI findings in first 20 patients [3 months post-op]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital for Special Surgery	New York	New York	United States	10021

Sponsors and Collaborators

• MiMedx Group, Inc.
• Hospital for Special Surgery, New York

Investigators

• Principal Investigator: Alexander Hughes, MD, Hospital for Special Surgery, New York

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: MiMedx Group, Inc.
• ClinicalTrials.gov Identifier: NCT02300909
• Other Study ID Numbers: AFLUD001; NCT02380456
• First Posted: Nov 25, 2014
• Last Update Posted: Aug 23, 2018
• Last Verified: Aug 1, 2018

• Additional relevant MeSH terms: Spinal Stenosis; Intervertebral Disc Displacement

Study Results

No Results Posted as of Aug 23, 2018