Clinical Trial Comparing Decompression With and Without Coflex™ Interlaminar Technology Treating Lumbar Spinal Stenosis

This study is currently recruiting participants.
Verified December 2012 by Paradigm Spine
Sponsor:
Collaborators:
MDT Medical Device Testing GmbH
Musculoskeletal Clinical Regulatory Advisers (MCRA)
Information provided by (Responsible Party):
Paradigm Spine
ClinicalTrials.gov Identifier:
NCT01316211
First received: March 15, 2011
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

A 5 year 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


Condition Intervention
Spinal Stenosis
Device: Implantation of coflex™ after surgical decompression
Procedure: Surgical decompression

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Paradigm Spine:

Primary Outcome Measures:
  • Status improvement of ODI [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • VAS Back Pain [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Neurological status (assessment of the maintenance of the improvement after surgery throughout the study duration)

  • Walking distance test [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Walking distance test on a treadmill (assessment of improvement in walking distance)

  • Adverse Events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Assessment of reoperations, revisions, removals, or supplemental fixation associated with either coflex or control group

  • Zurich Claudication Questionnaire (ZCQ) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    The ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis.


Estimated Enrollment: 230
Study Start Date: January 2008
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Radiographic confirmation of clinical symptoms of at least moderate degenerative spinal stenosis, with constriction of the central spinal canal of one or two adjacent segments in the region L3 to L5 with the need for decompression.

    If necessary additional decompression in the adjacent segment(s) may be performed avoiding any instability in the affected segment.

    In addition the following may exist (but is not obligatory):

    • hypertrophy of the facet joints and subarticular recessus stenosis in the relevant segment or
    • stenosis of the foramen in the relevant segment
    • and/or stable retrolisthesis up to grade I verified by flexion-/extension X-ray films.
  2. Radiographic confirmation of no translatory instability in the main segment as well as in adjacent segments (dynamic translatory instability ≤ 3 mm).
  3. VAS back pain score of at least 50 mm on a 100 mm scale (for acute back pain or a period of at least 3 month of back pain before the onset of leg pain).
  4. Minimum of 3 months conservative therapy without improvement of symptoms.
  5. Age >40 years.
  6. Oswestry Low Back Pain Disability Questionnaire score of at least 18/45 (40%) for German sites or 20/50 (40%) for the US sites (The question about sexual life will be excluded).
  7. Suitability of the patient for a posterior surgery procedure.
  8. Mental and physical ability of patient to follow the protocol according to compliance to time schedule, treatment plan, fill in of CRF pages and further study procedures.
  9. Personally signed informed consent form before the start of any study related procedures.

Exclusion Criteria

Any of the following will exclude a subject from the study:

  1. Preceding fusion or decompression surgery of the lumbar spine or preceding nucleotomy of the segments of concern (also if nucleotomy becomes necessary during surgery).
  2. Radiographically confirmed damage of the vertebral body in the segment of concern in the lumbar spine (e.g. osteoporotic compression fracture or because of tumors)
  3. Isthmic and degenerative spondylolisthesis (anterolisthesis; retrolisthesis > grade I) or spondylolysis (Pars fracture).
  4. Degenerative lumbar scoliosis (> 25°).
  5. Adipositas (obesity). Defined as a body mass index >40.
  6. Pregnancy, or wish to get pregnant during the course of the study.
  7. Known allergy for titanium and titanium alloys.
  8. Fluoride infections - both systemic and local.
  9. History of severe peripheral neuropathy.
  10. Significant peripheral vascular disease (claudication intermittens ≥ stage 2b).
  11. M. Paget or osteomalacia or other metabolic bone disorders.
  12. Cauda equina syndrome.
  13. Communicating diseases, including HIV, active hepatitis
  14. Patients who are lawfully kept in an institution.
  15. Subjects who, in the opinion of the investigator, will be inappropriate for inclusion into this clinical trial or will not comply with requirements of the study.
  16. Subjects who participated in a clinical observation or therapy with X-ray during the last 10 years.
  17. Subjects who participate(d) in another clinical trial (within the last 4 weeks) that might influence the safety and effectiveness assessment of this trial.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01316211

Contacts
Contact: Michael Rauschmann, MD +49 69 67 05 ext 404 m.rauschmann@friedrichsheim.de
Contact: Abigail Allen 202-552-5800 aallen@mcra.com

Locations
Germany
Oberlinklinik Potsdam Orthopädische Fachklinik Recruiting
Potsdam, Brandenburg, Germany, 14482
Principal Investigator: Axel Reinhardt, MD         
Sub-Investigator: Raik Neumann, MD         
Orthopädische Universitätsklinik Frankfurt a.M. Recruiting
Frankfurt a.M., Hesse, Germany, 60528
Contact: Michael Rauschmann, MD    +49 69 67 05 ext 404    m.rauschmann@friedrichsheim.de   
Principal Investigator: Rauschmann Michael, MD         
Sub-Investigator: Schmidt Sven, MD         
Chirurgische Universitätsklinik Rostock Neurochirurgie Recruiting
Rostock, Mecklenburg-Western Pomerania, Germany, 18057
Principal Investigator: Jürgen Piek, MD         
Sub-Investigator: Steffen Sola, MD         
Otto-von-Guericke-Universität Magdeburg Klinik für Orthopädie Recruiting
Magdeburg, Saxony-Anhalt, Germany, 39120
Principal Investigator: Jörg Franke, MD         
Sub-Investigator: Janina Sedlaczek, MD         
Ostseeklinik Damp Neurochirurgie Recruiting
Damp, Schleswig-Holstein, Germany, 24351
Principal Investigator: Dieter Adelt, MD         
Sub-Investigator: Christine Raschdorff, MD         
Klinik für Neurochirurgie Lübeck Recruiting
Lübeck, Schleswig-Holstein, Germany, 23730
Principal Investigator: Matteo Bonsanto, MD         
Klinik für Wirbelsäulenchirurgie mit Skoliosezentrum Klinikum Neustadt Recruiting
Neustadt, Schleswig-Holstein, Germany, 23730
Principal Investigator: Henry Halm, MD         
Sub-Investigator: Kathrin Nieselt, MD         
Sub-Investigator: Markus Quante, MD         
Klinikum Ingolstadt Neurochirurgie Recruiting
Ingolstadt, Germany, 85049
Contact: Vladimir Sklencar, M.D.    +49 874 880 2551    vladimir.sklencar@klinikum-ingolstadt.de   
Principal Investigator: Vladimir Sklencar, M.D.         
Sponsors and Collaborators
Paradigm Spine
MDT Medical Device Testing GmbH
Musculoskeletal Clinical Regulatory Advisers (MCRA)
  More Information

No publications provided

Responsible Party: Paradigm Spine
ClinicalTrials.gov Identifier: NCT01316211     History of Changes
Other Study ID Numbers: 06k004
Study First Received: March 15, 2011
Last Updated: December 19, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

Keywords provided by Paradigm Spine:
Back Pains
Pain, Back
Pains, Back
Backache
Backaches
Back Ache
Ache, Back
Aches, Back
Back Aches
Back Pain without Radiation
Vertebrogenic Pain Syndrome
Pain Syndrome, Vertebrogenic
Pain Syndromes, Vertebrogenic
Syndrome, Vertebrogenic Pain
Syndromes, Vertebrogenic Pain
Vertebrogenic Pain Syndromes
Back Pain with Radiation
Stenosis, spinal
Caudal stenosis
Spondylopathy
Spondylopathies
Low back pain
Lower back pain

Additional relevant MeSH terms:
Constriction, Pathologic
Low Back Pain
Spinal Stenosis
Pathological Conditions, Anatomical
Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 16, 2014