Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy (LOPAIN1)
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|ClinicalTrials.gov Identifier: NCT04141098|
Recruitment Status : Recruiting
First Posted : October 28, 2019
Last Update Posted : March 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Degenerative Disc Disease Chronic Low-back Pain||Device: All patients that meet the inclusion/exclusion criteria will receive the PerQdisc® Nucleus Replacement Device.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is an open-label study. Patients will receive one implant if they meet all inclusion/exclusion criteria after a review by the Medical Advisory Board (MAB). Patients that cannot receive the implant due to an intraoperative exclusion, will receive standard of care treatment.|
|Masking:||None (Open Label)|
|Official Title:||Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy - LOPAIN1|
|Actual Study Start Date :||October 10, 2019|
|Estimated Primary Completion Date :||October 30, 2021|
|Estimated Study Completion Date :||October 30, 2022|
Experimental: Total Nucleus Replacement
All patients that meet the inclusion/exclusion criteria will receive the PerQdisc® Nucleus Replacement Device.
Device: All patients that meet the inclusion/exclusion criteria will receive the PerQdisc® Nucleus Replacement Device.
All patients meeting all inclusion criteria and no exclusion criteria will be considered for nucleus replacement surgery following a review by the Medical Advisory Board. Any patient meeting any of the three intraoperative exclusion criteria will receive an alternative standard of care therapy.
- Post surgical change in degree of disability [ Time Frame: 6 months ]Patient reported outcomes for degree of disability will be monitored using the Oswestry Disability Index (scale of 0-100). Higher scores indicate greater level of disability.
- Post surgical change in back pain: Visual Analogue Scale [ Time Frame: 6 months ]Patient reported outcomes will be reported using the Visual Analogue Scale (0-100mm). Higher scores indicate greater levels of back 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): NCT04141098
|Contact: Jeffrey Griebelfirstname.lastname@example.org|
|Asunción, Paraguay, 1101|
|Contact: Carlos Cetraro email@example.com|
|Principal Investigator: Francisco Duarte, MD|
|Study Chair:||Michael Hess, MD||London Spine Clinic/ATOS-Klinik|