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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01316211
First Posted: March 16, 2011
Last Update Posted: February 6, 2017
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.
Collaborators:
MDT Medical Device Testing GmbH
Musculoskeletal Clinical Regulatory Advisers
Information provided by (Responsible Party):
Paradigm Spine
March 15, 2011
March 16, 2011
February 6, 2017
January 2008
August 2014   (Final data collection date for primary outcome measure)
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.
Status improvement of ODI [ Time Frame: 24 months ]
The primary variable of performance is the assessment of Oswestry Low Back Pain Disability Index (ODI) in both treatment groups at 24months. 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.
Complete list of historical versions of study NCT01316211 on ClinicalTrials.gov Archive Site
  • 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.
  • Improvement of the VAS [ Time Frame: 24 months ]
    Superior improvement of the Visual Analog Scale (VAS) for low back pain (on the 100 mm scale) within 24 months compared to control group
  • Leg Pain [ Time Frame: 24 months ]
    Leg pain (Measurement via a 100 mm VAS)
  • ZCQ [ Time Frame: 24 months ]
    Zurich Claudication Questionnaire (ZCQ)
  • Migration of device [ Time Frame: 24 months ]
    Assessment of significant migration of the implant or the complete expulsion (significant is defined > 5 mm)
  • Neurological status [ Time Frame: 24 months ]
    Neurological status (assessment of the maintenance of the improvement after surgery throughout the study duration)
  • Walking distance test [ Time Frame: 24 months ]
    Walking distance test on a treadmill (assessment of improvement in walking distance)
  • Adverse Events [ Time Frame: 24 months ]
    Documentation of Adverse Events (S)AEs and implant related complications (e.g. breaking of implants)
  • Assessment of revisions and additional stabilizations [ Time Frame: 24 months ]
    Assessment of revisions and additional stabilizations
Not Provided
Not Provided
 
Clinical Trial Comparing Decompression With and Without Coflex™ Interlaminar Technology Treating Lumbar Spinal Stenosis
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
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

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Spinal Stenosis
  • Device: Implantation of coflex™ after surgical decompression
    The device will be implanted after surgical decompression in patients with spinal stenosis.
  • Procedure: Surgical decompression
    Surgical decompression in patients with spinal stenosis without stabilization by an additional implant
  • Active Comparator: coflex™
    Implantation of coflex™ device in assigned patients
    Intervention: Device: Implantation of coflex™ after surgical decompression
  • Active Comparator: Surgical decompression
    Surgical decompression in patients with spinal stenosis without stabilization by an additional implant.
    Intervention: Procedure: Surgical decompression
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
245
December 2017
August 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01316211
06k004
No
Not Provided
Not Provided
Paradigm Spine
Paradigm Spine
  • MDT Medical Device Testing GmbH
  • Musculoskeletal Clinical Regulatory Advisers
Not Provided
Paradigm Spine
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP