Clinical Trials Logo

Clinical Trial Summary

To evaluate clinical, radiologic and patient-reported outcomes who have been treated 1 or 2 levels with the coflex® Interlaminar Technology or decompression with or without fusion.


Clinical Trial Description

The coflex® Interlaminar Technology - manufactured by Paradigm Spine - is intended for use as a permanent implant between the lamina of 1 or 2 lumbar motion segments in the treatment of moderate to severe lumbar spinal stenosis. The device is specifically designed to provide stabilization without fusion in cases of stenosis with or without facet joint hypertrophy, subarticular recess stenosis or foraminal stenosis. It is restricted for use to one or two levels in the region of L1 - L5.

The height of the neuroforamen is maintained and the facet joints will be relieved. By this a further destruction is prevented. Unlike conventional stabilization methods as for example spinal fusion, the function of the segment will be maintained and adjacent structures will be effectively protected.

Possible risks, which could occur after implantation of the coflex® Interlaminar Technology are breakage of the implant, displacement of the implant, pain which is caused by the implant, infections, bleedings and hematoma. The benefit of the study lies in the fact that first-time retrospective data is raised for potential improvement regarding therapy of lumbar back pain with the treatment of the lumbar spinal stenosis, which, in the future, can lead to an improvement of the therapy.

In this study, Paradigm Spine will retrospectively collect clinical and radiographic data for patients treated with the coflex® Interlaminar Technology during normal conditions of use. This data will provide evidence to support publications and marketing. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03041896
Study type Observational
Source Paradigm Spine
Contact
Status Completed
Phase
Start date July 2016
Completion date August 2018

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Withdrawn NCT03223701 - Efficacy of Using Solum IV and BMC With GFC in TLIF Phase 4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 NCT00022776 - Surgical Versus Nonsurgical Treatment for Spinal Stenosis Phase 3
Completed NCT00320619 - Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following Spine Surgery N/A
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