Post-market Study of the TOPS™ System
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|ClinicalTrials.gov Identifier: NCT02234154|
Recruitment Status : Unknown
Verified April 2016 by Premia Spine.
Recruitment status was: Recruiting
First Posted : September 9, 2014
Last Update Posted : April 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Lumbar Spinal Stenosis Spondylolisthesis||Device: TOPS System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study to Evaluate the Safety and Effectiveness of the TOPS System|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||March 2017|
|Estimated Study Completion Date :||May 2017|
Post Marketing Study
Device: TOPS System
Non-randomized study involving implantation of a TOPS via lumbar surgery to decompress and provide stability to the index level.
- Improvement in ODI and Improvement in VAS leg score v [ Time Frame: 24 months post implantation ]Composite endpoint - Subjects who exhibit a reduction of 15 percent in their Oswestry Disability Index (ODI) score compared to their preoperative ODI score AND a reduction of at least 20mm (20% improvement) in either of their VAS Leg Score will be considered a success.
- Improvement in back and leg visual analog scales (VAS) [ Time Frame: 24 month postoperatively ]A failure to meet of any of the secondary endpoints will not be considered a therapeutic failure unless such a failure requires subsequent surgical intervention.
- Improvement in ZCQ scores [ Time Frame: 24 months postoperatively ]A failure to meet of any of the secondary endpoints will not be considered a therapeutic failure unless such a failure requires subsequent surgical intervention.
- Quality of life (SF-36) [ Time Frame: 24 months postoperatively ]A failure to meet of any of the secondary endpoints will not be considered a therapeutic failure unless such a failure requires subsequent surgical intervention.
- Maintenance or improvement in neurological symptoms [ Time Frame: 24 months postoperatively ]
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): NCT02234154
|Contact: Masood Shafafy, MD||+44 (0)115 9249924 ext email@example.com|
|Queens Medical Centre||Recruiting|
|Nottingham, Nottinghamshire, United Kingdom, NG7 2UH|
|Contact: Bronek Boszczyk, MD +44 (0)115 9249924 firstname.lastname@example.org|
|Principal Investigator: Masood Shafafy, MD|
|Principal Investigator:||Masood Shafafy, MD||Queens Medical Centre Nottingham|