Efficacy of a Full-Thickness Placental Allograft in Lumbar Microdiscectomy

A Clinical Investigation Evaluating Efficacy of a Full-Thickness Placental Allograft in Lumbar Microdiscectomy Outcomes

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.

Study Overview

• Status: Terminated
• Conditions: Surgical Wound; Herniation
• Intervention / Treatment: Other: Other: Full-thickness placental allograft

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Polaris Spine and Neurosurgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measuring efficacy of full-thickness placental allograft in reducing back and leg pain post-microdiscectomy.	Oswestry Disability Index (ODI)	24 months
Measuring efficacy of full-thickness placental allograft in reducing back and leg pain post-microdiscectomy.	12-Item Short Form Survey (SF12)	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of post-microdiscectomy reherniation rate.	Reherniation rates will be compared between the experimental and control groups.	24 month

Collaborators and Investigators

• Sponsor: StimLabs
• Investigators: Principal Investigator: Thomas Morrison, M.D., Polaris Spine and Neurosurgery

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2018
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: April 30, 2018
• First Submitted That Met QC Criteria: May 23, 2018
• First Posted (Actual): May 24, 2018

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: DSP17-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The sponsor will not have access to personally identifying participant information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No