dHACM in Lumbar Decompression and Microdiscectomy Surgery | NCT02300909

Studies
dHACM in Lumbar Decompression and Microdiscectomy Surgery

NCT02300909

Sponsor

MiMedx Group, Inc.

Status

Completed

Last Update Posted

Aug 23, 2018Actual

Enrollment

143Actual

Phase

Not Applicable

Conditions

Scarring
Spinal Stenosis
Herniated Disc

Interventions

Lumbar Decompression Surgery
Microdiscectomy Surgery
Dehydrated Human Amnion/Chorion Membrane (dHACM)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Jun 2018Actual

Completion Date

Jun 2018Actual

First Submitted Date

Nov 18, 2014

First Submission Date that Met QC Criteria

Nov 24, 2014

First Posted Date

Nov 25, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 22, 2018

Last Update Posted Date

Aug 23, 2018Actual

Name	Class
Hospital for Special Surgery, New York	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

143Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
dHACM	Experimental	Lumbar Decompression Surgery or Microdiscectomy Surgery with Application of Dehydrated Human Amnion/Chorion Membrane (dHACM)	Procedure: Lumbar Decompression Surgery Procedure: Microdiscectomy Surgery Other: Dehydrated Human Amnion/Chorion Membrane (dHACM)
Surgery without dHACM	Other	Control Group - Lumbar Decompression Surgery or Microdiscectomy Surgery without application of dHACM	Procedure: Lumbar Decompression Surgery Procedure: Microdiscectomy Surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lumbar Decompression Surgery	Procedure	Lumbar Decompression Surgery	Surgery without dHACM dHACM

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Oswestry Disability Index	Patient Functional Outcomes Questionnaire	2 years

Secondary Outcomes

Measure	Description	Time Frame
Re-operation (Number of patients having re-operation during study)	Number of patients having re-operation during study	2 years
Scar formation in revision cases	Dissection of scar formation required at re-operation

Other Outcomes

Measure	Description	Time Frame
MRI findings in first 20 patients		3 months post-op

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Are 18 (eighteen) years of age or older at the time of surgery.
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
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.
Are willing and able to sign study specific informed consent.

Exclusion Criteria:

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.
Allergic to aminoglycoside antibiotics
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
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 a MRI

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D002921	Cicatrix
D013130	Spinal Stenosis
D007405	Intervertebral Disc Displacement

ID	Term
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D013122	Spinal Diseases