Atlanta, Georgia 30328

  • Herniation

Purpose:

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 summary:

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.


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.


NCT ID:

NCT03536013


Primary Contact:

Principal Investigator
Thomas Morrison, M.D.
Polaris Spine and Neurosurgery

Chas Director of Marketing, B.S.
Phone: 4044870398
Email: chas@stimlabs.com


Backup Contact:

Operations Supervisor, B.S.
Phone: 4049366099


Location Contact:

Atlanta, Georgia 30328
United States

Carlie Ivie
Phone: 404-256-2633
Email: civie@polarisspine.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 24, 2021

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