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Efficacy of a Full-Thickness Placental Allograft in Lumbar Microdiscectomy

Primary Purpose

Surgical Wound, Herniation

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Other: Full-thickness placental allograft
Sponsored by
StimLabs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Wound

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Ambulatory with radiating low back and leg pain for greater than 6 months prior to surgery with clinical diagnosis of lumbar protruding disc.
  • Consent and compliance with all aspects of the study protocol, methods, providing data during follow-up contact.

Exclusion Criteria:

  • Severe hypertension systolic blood pressure (greater than or equal to 200 mm -Hg or diastolic blood pressure greater than or equal to 182 mm Hg)
  • BMI greater than 45 kg/m2
  • Subject has had major surgery at the index level
  • Is an active smoker or stopped smoking in the last 6 months
  • Any pain that could interfere with the assessment of index level pain (e.g. pain in any other part of the spine)
  • Active rheumatoid arthritis
  • Active, local or systemic malignancy such as lung cancer or leukemia
  • History of vascular disease or sickle cell anemia
  • Use of the following medications:

No significant anticoagulant therapy (e.g. Heparin or Lovenox) during the study (treatment such as Aspirin and Plavix are allowed)

  • No systemic treatments that may interfere with safety or efficacy assessments during the study
  • No immunosuppressants

  • No use of corticosteroids

    • Subject is pregnant or plans to become pregnant within 24 months of treatment
    • Subject does not provide full consent
    • Personal injury, workman's compensation or other legally-related treatment patients.

Sites / Locations

  • Polaris Spine and NeurosurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment

Control

Arm Description

91 patients will undergo a typical lumbar microdiscectomy with the addition of a full-thickness placental allograft after the microdiscectomy has been performed.

91 patients will undergo a typical lumbar microdiscectomy without the addition of a full-thickness placental allograft.

Outcomes

Primary Outcome Measures

Measuring efficacy of full-thickness placental allograft in reducing back and leg pain post-microdiscectomy.
Oswestry Disability Index (ODI)
Measuring efficacy of full-thickness placental allograft in reducing back and leg pain post-microdiscectomy.
12-Item Short Form Survey (SF12)

Secondary Outcome Measures

Evaluation of post-microdiscectomy reherniation rate.
Reherniation rates will be compared between the experimental and control groups.

Full Information

First Posted
April 30, 2018
Last Updated
May 14, 2019
Sponsor
StimLabs
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1. Study Identification

Unique Protocol Identification Number
NCT03536013
Brief Title
Efficacy of a Full-Thickness Placental Allograft in Lumbar Microdiscectomy
Official Title
A Clinical Investigation Evaluating Efficacy of a Full-Thickness Placental Allograft in Lumbar Microdiscectomy Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 3, 2018 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
StimLabs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the efficacy of full thickness placental allograft use in Microdiscectomy application. To evaluate post-microdiscectomy reherniation rate in patients treated with full-thickness placental allografts.
Detailed Description
The primary objective is to evaluate the efficacy of full thickness placental allograft use in improving back and leg pain, when applied to patients undergoing lumbar microdiscectomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound, Herniation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Blind study
Masking
Participant
Allocation
Randomized
Enrollment
182 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
91 patients will undergo a typical lumbar microdiscectomy with the addition of a full-thickness placental allograft after the microdiscectomy has been performed.
Arm Title
Control
Arm Type
No Intervention
Arm Description
91 patients will undergo a typical lumbar microdiscectomy without the addition of a full-thickness placental allograft.
Intervention Type
Other
Intervention Name(s)
Other: Full-thickness placental allograft
Intervention Description
A full-thickness placental allograft will be applied to the annulus of the index lumbar level prior to site closure.
Primary Outcome Measure Information:
Title
Measuring efficacy of full-thickness placental allograft in reducing back and leg pain post-microdiscectomy.
Description
Oswestry Disability Index (ODI)
Time Frame
24 months
Title
Measuring efficacy of full-thickness placental allograft in reducing back and leg pain post-microdiscectomy.
Description
12-Item Short Form Survey (SF12)
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Evaluation of post-microdiscectomy reherniation rate.
Description
Reherniation rates will be compared between the experimental and control groups.
Time Frame
24 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Ambulatory with radiating low back and leg pain for greater than 6 months prior to surgery with clinical diagnosis of lumbar protruding disc. Consent and compliance with all aspects of the study protocol, methods, providing data during follow-up contact. Exclusion Criteria: Severe hypertension systolic blood pressure (greater than or equal to 200 mm -Hg or diastolic blood pressure greater than or equal to 182 mm Hg) BMI greater than 45 kg/m2 Subject has had major surgery at the index level Is an active smoker or stopped smoking in the last 6 months Any pain that could interfere with the assessment of index level pain (e.g. pain in any other part of the spine) Active rheumatoid arthritis Active, local or systemic malignancy such as lung cancer or leukemia History of vascular disease or sickle cell anemia Use of the following medications: No significant anticoagulant therapy (e.g. Heparin or Lovenox) during the study (treatment such as Aspirin and Plavix are allowed) No systemic treatments that may interfere with safety or efficacy assessments during the study No immunosuppressants No use of corticosteroids Subject is pregnant or plans to become pregnant within 24 months of treatment Subject does not provide full consent Personal injury, workman's compensation or other legally-related treatment patients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chas Director of Marketing, B.S.
Phone
4044870398
Email
chas@stimlabs.com
First Name & Middle Initial & Last Name or Official Title & Degree
Operations Supervisor, B.S.
Phone
4049366099
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Morrison, M.D.
Organizational Affiliation
Polaris Spine and Neurosurgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Polaris Spine and Neurosurgery
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlie Ivie
Phone
404-256-2633
Ext
163
Email
civie@polarisspine.com
First Name & Middle Initial & Last Name & Degree
Lydia Jones
Phone
4042562633
Email
lwjones95@gmail.com
First Name & Middle Initial & Last Name & Degree
Thomas Morrison, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The sponsor will not have access to personally identifying participant information.

Learn more about this trial

Efficacy of a Full-Thickness Placental Allograft in Lumbar Microdiscectomy

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