Efficacy of a Full-Thickness Placental Allograft in Lumbar Microdiscectomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Surgical Wound, Herniation

Intervention / Treatment
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* Other: Other: Full-thickness placental allograft


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Blind study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>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<br>* A full-thickness placental allograft will be applied to the annulus of the index lumbar level prior to site closure.<br>|
| No Intervention: Control<br>91 patients will undergo a typical lumbar microdiscectomy without the addition of a full-thickness placental allograft. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of post-microdiscectomy reherniation rate. | Reherniation rates will be compared between the experimental and control groups. | 24 month |