Efficacy of a Full-Thickness Placental Allograft in Lumbar Microdiscectomy

NCT ID: NCT03536013

Last Updated: 2024-07-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-03
• Study Completion Date: 2019-08-01

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.

Conditions

Surgical Wound; Herniation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment

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

Group Type: EXPERIMENTAL

Other: Full-thickness placental allograft

Intervention Type: OTHER

A full-thickness placental allograft will be applied to the annulus of the index lumbar level prior to site closure.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

StimLabs

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Morrison, M.D.

Role: PRINCIPAL_INVESTIGATOR

Polaris Spine and Neurosurgery

Locations

Polaris Spine and Neurosurgery

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

DSP17-002

Identifier Type: -

Identifier Source: org_study_id