Efficacy of a Full-Thickness Placental Allograft in Lumbar Microdiscectomy

NCT03536013 | Terminated

• 1 other identifier: DSP17-002
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Wound; Herniation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Evaluation of post-microdiscectomy reherniation rate.

  24 month

Study Arms (2)

Treatment

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Other: Full-thickness placental allograft OTHER

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

Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• StimLabs: lead

Study Sites (1)

Polaris Spine and Neurosurgery

Atlanta, Georgia, 30328, United States

Location

MeSH Terms

Conditions

Surgical Wound; Hernia

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Morrison, M.D.

  Polaris Spine and Neurosurgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Blind study

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: May 24, 2018
• Study Start: May 3, 2018
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)