Efficacy of a Full-Thickness Placental Allograft in Lumbar Microdiscectomy
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|ClinicalTrials.gov Identifier: NCT03536013|
Recruitment Status : Recruiting
First Posted : May 24, 2018
Last Update Posted : May 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Surgical Wound Herniation||Other: Other: Full-thickness placental allograft||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||182 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Blind study|
|Official Title:||A Clinical Investigation Evaluating Efficacy of a Full-Thickness Placental Allograft in Lumbar Microdiscectomy Outcomes|
|Actual Study Start Date :||May 3, 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
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
A full-thickness placental allograft will be applied to the annulus of the index lumbar level prior to site closure.
No Intervention: Control
91 patients will undergo a typical lumbar microdiscectomy without the addition of a full-thickness placental allograft.
- Measuring efficacy of full-thickness placental allograft in reducing back and leg pain post-microdiscectomy. [ Time Frame: 24 months ]Oswestry Disability Index (ODI)
- Measuring efficacy of full-thickness placental allograft in reducing back and leg pain post-microdiscectomy. [ Time Frame: 24 months ]12-Item Short Form Survey (SF12)
- Evaluation of post-microdiscectomy reherniation rate. [ Time Frame: 24 month ]Reherniation rates will be compared between the experimental and control groups.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03536013
|Contact: Chas Director of Marketing, B.S.||firstname.lastname@example.org|
|Contact: Operations Supervisor, B.S.||4049366099|
|United States, Georgia|
|Polaris Spine and Neurosurgery||Recruiting|
|Atlanta, Georgia, United States, 30328|
|Contact: Carlie Ivie 404-256-2633 ext 163 email@example.com|
|Contact: Lydia Jones 4042562633 firstname.lastname@example.org|
|Principal Investigator: Thomas Morrison, M.D.|
|Principal Investigator:||Thomas Morrison, M.D.||Polaris Spine and Neurosurgery|