Herniation, Surgical Wound
Conditions
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.
Interventions
OTHEROther: Full-thickness placental allograft
A full-thickness placental allograft will be applied to the annulus of the index lumbar level prior to site closure.
Sponsors
StimLabs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Blind study
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measuring efficacy of full-thickness placental allograft in reducing back and leg pain post-microdiscectomy. | 24 months | Oswestry Disability Index (ODI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of post-microdiscectomy reherniation rate. | 24 month | Reherniation rates will be compared between the experimental and control groups. |
Countries
United States
Outcome results
None listed