Clinical Trial Comparing Decompression With and Without Coflex™ Interlaminar Technology Treating Lumbar Spinal Stenosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01316211|
Recruitment Status : Active, not recruiting
First Posted : March 16, 2011
Last Update Posted : February 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Spinal Stenosis||Device: Implantation of coflex™ after surgical decompression Procedure: Surgical decompression||Not Applicable|
The coflex® implant for interlaminar stabilization has been in clinical use for more than 10 years and is CE-certified according to the standards and approved in the United States.
With this randomized multicenter study prospective data for potential improvement in the therapy of low back pain during the treatment of spinal stenosis is generated for the first time. The study is being conducted at sites in both Germany and US.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||245 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparative Evaluation of Clinical Outcome in the Treatment of Degenerative Spinal Stenosis With Concomitant Low Back Pain by Decompression With and Without Additional Stabilization Using the Coflex™ Interlaminar Technology|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||August 2014|
|Estimated Study Completion Date :||December 2017|
Active Comparator: coflex™
Implantation of coflex™ device in assigned patients
Device: Implantation of coflex™ after surgical decompression
The device will be implanted after surgical decompression in patients with spinal stenosis.
Active Comparator: Surgical decompression
Surgical decompression in patients with spinal stenosis without stabilization by an additional implant.
Procedure: Surgical decompression
Surgical decompression in patients with spinal stenosis without stabilization by an additional implant
- Status improvement of ODI [ Time Frame: 5 years ]The primary variable of performance is the assessment of Oswestry Low Back Pain Disability Index (ODI) in both treatment groups at 5 years. It will be assessed if the improvement in ODI since the pre surgery status in the coflex™ group is better than the improvement in the control group.
- VAS Back Pain [ Time Frame: 5 years ]Improvement of the Visual Analog Scale (VAS) for low back pain (on the 100 mm scale) compared to control group
- VAS Leg Pain [ Time Frame: 5 years ]Improvement of the Visual Analog Scale (VAS) for leg pain(on the 100 mm scale) compared to control group
- Radiographic Assessment [ Time Frame: 5 years ]Radiographic Assessment of coflex and control group including range of motion, radiolucency, device displacement, spinous process fractures, heterotopic ossification
- Neurological status [ Time Frame: 5 years ]Neurological status (assessment of the maintenance of the improvement after surgery throughout the study duration)
- Walking distance test [ Time Frame: 5 years ]Walking distance test on a treadmill (assessment of improvement in walking distance)
- Adverse Events [ Time Frame: 5 years ]Documentation of Adverse Events (S)AEs and implant related complications (e.g. breaking of implants)
- Re-operations, revisions, removals, supplemental fixation [ Time Frame: 5 years ]Assessment of reoperations, revisions, removals, or supplemental fixation associated with either coflex or control group
- Zurich Claudication Questionnaire (ZCQ) [ Time Frame: 5 years ]The ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis.
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): NCT01316211
|Oberlinklinik Potsdam Orthopädische Fachklinik|
|Potsdam, Brandenburg, Germany, 14482|
|Orthopädische Universitätsklinik Frankfurt a.M.|
|Frankfurt a.M., Hesse, Germany, 60528|
|Chirurgische Universitätsklinik Rostock Neurochirurgie|
|Rostock, Mecklenburg-Western Pomerania, Germany, 18057|
|Otto-von-Guericke-Universität Magdeburg Klinik für Orthopädie|
|Magdeburg, Saxony-Anhalt, Germany, 39120|
|Ostseeklinik Damp Neurochirurgie|
|Damp, Schleswig-Holstein, Germany, 24351|
|Klinik für Neurochirurgie Lübeck|
|Lübeck, Schleswig-Holstein, Germany, 23730|
|Klinik für Wirbelsäulenchirurgie mit Skoliosezentrum Klinikum Neustadt|
|Neustadt, Schleswig-Holstein, Germany, 23730|
|Klinikum Ingolstadt Neurochirurgie|
|Ingolstadt, Germany, 85049|