Clinical Trials Logo

Clinical Trial Summary

This Single-Arm Post-Marketing Evaluation will gauge the improvement in function and pain for lumbar spinal stenosis and spondylolisthesis patients with the TOPS System.


Clinical Trial Description

This Single-Arm Post-Marketing Evaluation will gauge the improvement in function and pain for lumbar spinal stenosis and spondylolisthesis patients with the TOPS System. Patients who are scheduled to undergo spinal surgery as part of their medical treatment and comply with the study inclusion/exclusion criteria will be recruited. Patients will undergo standard surgical decompression prior to device implantation. For patients with two or three levels of disease, the TOPS System will be combined with the Versalink Fixation System. All study devices are CE marked. ;


Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01933607
Study type Interventional
Source Premia Spine
Contact Stephen McGillion, MD
Phone 02380796245
Email Stephen.McGillion@uhs.nhs.uk
Status Recruiting
Phase N/A
Start date May 2014
Completion date December 2016

See also
  Status Clinical Trial Phase
Completed NCT06290908 - RPE-P/TLIF for Lumbar Spinal Stenosis With Instability
Withdrawn NCT03223701 - Efficacy of Using Solum IV and BMC With GFC in TLIF Phase 4
Recruiting NCT03883022 - Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery N/A
Completed NCT02902380 - The Effect of Dexmedetomidine on Neuroendocrine Stress Hormone Release and Heart Rate Variability in Patients Undergoing Major Spinal Surgery N/A
Not yet recruiting NCT06024785 - Vertebropexy - Randomized-controlled Trial N/A
Not yet recruiting NCT06000319 - Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion
Completed NCT02558621 - New Robotic Assistance System for Spinal Fusion Surgery N/A
Completed NCT02454400 - Pre-surgery Physiotherapy for Patients With Specific Low Back Pain N/A
Completed NCT01377623 - Pilot Study on the Effect of Dexmedetomidine on Inflammatory Responses in Patients Undergoing Lumbar Spinal Fusion N/A
Completed NCT00996073 - Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion Phase 2
Terminated NCT00974623 - Bone Graft Materials Observational Registry N/A
Completed NCT00320619 - Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following Spine Surgery N/A
Completed NCT00022776 - Surgical Versus Nonsurgical Treatment for Spinal Stenosis Phase 3
Completed NCT06060821 - Validity and Reliability of the 2-minute Step Test in Patients With Lumbar Spinal Stenosis
Recruiting NCT04552145 - Physical Therapy vs Surgical Decompression for Lumbar Spinal Stenosis N/A
Active, not recruiting NCT04379921 - Improving Spine Surgical Care With Real-Time Objective Patient Tracking Using the Apple Watch N/A
Withdrawn NCT04315090 - Post-surgical Outcomes Measure Using the ERAS Protocol for Posterior Cervical Decompression and Fusion
Completed NCT04591249 - Physical Activity Intervention for Patients Following Lumbar Spine Surgery N/A
Recruiting NCT04601363 - Personalized Spine Study Group (PSSG) Registry
Completed NCT04193488 - Mid-Transverse Process to Pleural (MTP) Block and Erector Spinal Plan (ESP) Block in Spinal Surgery N/A