Efficacy of a Full-Thickness Placental Allograft in Lumbar Microdiscectomy

Surgical Wound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03536013
• Other study ID #: DSP17-002
• Status: Recruiting
• Phase: N/A
• Start date: May 3, 2018
• Est. completion date: December 2020

Study information

• Verified date: May 2019
• Source: StimLabs
• Contact: Chas Director of Marketing, B.S.
• Phone: 4044870398
• Email: chas[@]stimlabs.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 182
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Herniation
• Surgical Wound

Intervention

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.

Locations

Country	Name	City	State
United States	Polaris Spine and Neurosurgery	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
StimLabs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measuring efficacy of full-thickness placental allograft in reducing back and leg pain post-microdiscectomy.	Oswestry Disability Index (ODI)	24 months
Primary	Measuring efficacy of full-thickness placental allograft in reducing back and leg pain post-microdiscectomy.	12-Item Short Form Survey (SF12)	24 months
Secondary	Evaluation of post-microdiscectomy reherniation rate.	Reherniation rates will be compared between the experimental and control groups.	24 month