Efficacy of a Full-Thickness Placental Allograft in Lumbar Microdiscectomy

Not Applicable

Terminated

• Conditions: Herniation; Surgical Wound

• Registration Number: NCT03536013
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-04-30
• Study Start: 2018-05-03
• Study First Submitted QC: 2018-05-23
• Study First Posted: 2018-05-24
• Primary Completion: 2019-08-01
• Study Completion: 2019-08-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-28
• Last Update Posted: 2024-07-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Evaluation of post-microdiscectomy reherniation rate.	24 month	Reherniation rates will be compared between the experimental and control groups.

Trial Locations

Locations (1)

Polaris Spine and Neurosurgery; 🇺🇸 Atlanta, Georgia, United States