Efficacy of a Full-Thickness Placental Allograft in Lumbar Microdiscectomy (NCT03536013) | Clinical Trial Compass
TerminatedNot Applicable
Efficacy of a Full-Thickness Placental Allograft in Lumbar Microdiscectomy
Stopped: Low enrollment.
United States27 participantsStarted 2018-05-03
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Measuring efficacy of full-thickness placental allograft in reducing back and leg pain post-microdiscectomy.
Timeframe: 24 months
2
Measuring efficacy of full-thickness placental allograft in reducing back and leg pain post-microdiscectomy.