Confirmatory Clinical Study of Oxiplex
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|ClinicalTrials.gov Identifier: NCT03433391|
Recruitment Status : Completed
First Posted : February 14, 2018
Last Update Posted : July 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Herniated Lumbar Disk||Device: Oxiplex Other: Surgery Only||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||135 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Confirmatory Clinical Study to Support the Effectiveness and Safety of Oxiplex for the Reduction of Pain and Symptoms Following Lumbar Surgery|
|Actual Study Start Date :||April 23, 2018|
|Actual Primary Completion Date :||June 23, 2020|
|Actual Study Completion Date :||June 23, 2020|
Surgery Plus Oxiplex
Oxiplex will be applied after hemostasis is achieved and prior to closure, in adult patients undergoing single level partial discectomy.
Oxiplex is a clear, viscoelastic gel that is applied to operative site during lumbar spine surgery in order to coat the nerve root with a protective barrier.
Standard of care procedures for adult patients undergoing single level partial discectomy will be followed.
Other: Surgery Only
Single level partial discectomy as per standard of care procedures.
- Change in ipsilateral leg pain [ Time Frame: Pre-op; 6 weeks; 3 months; 6 months ]Subjects will complete a Visual Analogue Scale (VAS) for their ipsilateral leg pain at each visit. The VAS is a continuous and linear, scale ranging from "No Pain" to "Worst Possible Pain".
- Change in back pain [ Time Frame: Pre-op; 6 weeks; 3 months; 6 months ]Subjects will complete a Visual Analogue Scale (VAS) for their back pain at each visit.The VAS is a continuous and linear, scale ranging from "No Pain" to "Worst Possible Pain".
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): NCT03433391
|Principal Investigator:||Jeffrey Fischgrund, MD||Beaumont Health|