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Efficacy of a Full-Thickness Placental Allograft in Lumbar Microdiscectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03536013
Recruitment Status : Recruiting
First Posted : May 24, 2018
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
StimLabs

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.

Condition or disease Intervention/treatment Phase
Surgical Wound Herniation Other: Other: Full-thickness placental allograft Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Blind study
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Clinical Investigation Evaluating Efficacy of a Full-Thickness Placental Allograft in Lumbar Microdiscectomy Outcomes
Actual Study Start Date : May 3, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Treatment
91 patients will undergo a typical lumbar microdiscectomy with the addition of a full-thickness placental allograft after the microdiscectomy has been performed.
Other: Other: Full-thickness placental allograft
A full-thickness placental allograft will be applied to the annulus of the index lumbar level prior to site closure.

No Intervention: Control
91 patients will undergo a typical lumbar microdiscectomy without the addition of a full-thickness placental allograft.



Primary Outcome Measures :
  1. Measuring efficacy of full-thickness placental allograft in reducing back and leg pain post-microdiscectomy. [ Time Frame: 24 months ]
    Oswestry Disability Index (ODI)

  2. Measuring efficacy of full-thickness placental allograft in reducing back and leg pain post-microdiscectomy. [ Time Frame: 24 months ]
    12-Item Short Form Survey (SF12)


Secondary Outcome Measures :
  1. Evaluation of post-microdiscectomy reherniation rate. [ Time Frame: 24 month ]
    Reherniation rates will be compared between the experimental and control groups.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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): NCT03536013


Contacts
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Contact: Chas Director of Marketing, B.S. 4044870398 chas@stimlabs.com
Contact: Operations Supervisor, B.S. 4049366099

Locations
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United States, Georgia
Polaris Spine and Neurosurgery Recruiting
Atlanta, Georgia, United States, 30328
Contact: Carlie Ivie    404-256-2633 ext 163    civie@polarisspine.com   
Contact: Lydia Jones    4042562633    lwjones95@gmail.com   
Principal Investigator: Thomas Morrison, M.D.         
Sponsors and Collaborators
StimLabs
Investigators
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Principal Investigator: Thomas Morrison, M.D. Polaris Spine and Neurosurgery
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Responsible Party: StimLabs
ClinicalTrials.gov Identifier: NCT03536013    
Other Study ID Numbers: DSP17-002
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The sponsor will not have access to personally identifying participant information.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Surgical Wound
Wounds and Injuries