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. Identifier: NCT01316211
Recruitment Status : Unknown
Verified February 2017 by Paradigm Spine.
Recruitment status was:  Active, not recruiting
First Posted : March 16, 2011
Last Update Posted : February 6, 2017
MDT Medical Device Testing GmbH
Musculoskeletal Clinical Regulatory Advisers
Information provided by (Responsible Party):
Paradigm Spine

Brief Summary:
A 2 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 or disease Intervention/treatment Phase
Spinal Stenosis Device: Implantation of coflex™ after surgical decompression Procedure: Surgical decompression Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 245 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2008
Actual Primary Completion Date : August 2014
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Neurological status [ Time Frame: 5 years ]
    Neurological status (assessment of the maintenance of the improvement after surgery throughout the study duration)

  5. Walking distance test [ Time Frame: 5 years ]
    Walking distance test on a treadmill (assessment of improvement in walking distance)

  6. Adverse Events [ Time Frame: 5 years ]
    Documentation of Adverse Events (S)AEs and implant related complications (e.g. breaking of implants)

  7. 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

  8. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 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
Sponsors and Collaborators
Paradigm Spine
MDT Medical Device Testing GmbH
Musculoskeletal Clinical Regulatory Advisers

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Paradigm Spine Identifier: NCT01316211     History of Changes
Other Study ID Numbers: 06k004
First Posted: March 16, 2011    Key Record Dates
Last Update Posted: February 6, 2017
Last Verified: February 2017

Keywords provided by Paradigm Spine:
Back Pains
Pain, Back
Pains, Back
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
Low back pain
Lower back pain

Additional relevant MeSH terms:
Constriction, Pathologic
Spinal Stenosis
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases