Efficacy of a Full-Thickness Placental Allograft in Lumbar Microdiscectomy

StimLabs

Status: Terminated

Conditions: Surgical Wound; Herniation

Treatments: Other: Other: Full-thickness placental allograft

Study type: Interventional

Funder types: Industry

Identifiers

NCT03536013

DSP17-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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27 participants in 2 patient groups

Treatment

Experimental group

Description:

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

Treatment:

Other: Other: Full-thickness placental allograft

Control

No Intervention group

Description:

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