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: Completed

Administrative data

• NCT number: NCT02300909
• Other study ID #: AFLUD001
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: June 2018

Study information

• Verified date: August 2018
• Source: MiMedx Group, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT02380456

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Herniated Disc
• Intervertebral Disc Displacement
• Scarring
• Spinal Stenosis

Intervention

Procedure:
• Lumbar Decompression Surgery
Lumbar Decompression Surgery
• Microdiscectomy Surgery
Microdiscectomy Surgery

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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
MiMedx Group, Inc.	Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	MRI findings in first 20 patients		3 months post-op
Primary	Oswestry Disability Index	Patient Functional Outcomes Questionnaire	2 years
Secondary	Re-operation (Number of patients having re-operation during study)	Number of patients having re-operation during study	2 years
Secondary	Scar formation in revision cases	Dissection of scar formation required at re-operation	2 years
Secondary	Quality of Life (VAS Pain)	VAS Pain	2 years
Secondary	Quality of Life (SF-36)	SF-36	2 years
Secondary	Quality of Life	HSS Lumbar Expectations Survey	2 years