Full Text View
Tabular View
No Study Results Posted
Related Studies
IDE Clinical Trial Comparing Coflex vs. Fusion to Treat Lumbar Spinal Stenosis (coflex)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Paradigm Spine.   Recruitment status was  Recruiting

First Received on September 20, 2007.   Last Updated on June 2, 2009   History of Changes
Sponsor: Paradigm Spine
Information provided by: Paradigm Spine
ClinicalTrials.gov Identifier: NCT00534235
  Purpose

To evaluate the safety and effectiveness of the coflex device compared to the control.


Condition Intervention
Lumbar Spinal Stenosis
Device: coflex
Procedure: fusion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: A Multicenter, Prospective, Randomized, Clinical Trial Comparing Stabilization With Coflex vs. Pedicle Screw Fixation and Fusion After Decompression for at Least Moderate Lumbar Spinal Stenosis

Resource links provided by NLM:


Further study details as provided by Paradigm Spine:

Estimated Enrollment: 460
Arms Assigned Interventions
Experimental: coflex
stabilization with coflex
Device: coflex
stabilization with coflex
Active Comparator: fusion
pedicle screw fixation and fusion after decompression
Procedure: fusion
pedicle screw fixation and posterolateral fusion after decompression

Detailed Description:

The objective of this clinical trial is to evaluate the safety and effectiveness of the coflex device compared to a surgical control, posterolateral fusion with autograft bone and pedicle screw fixation, following decompressive laminectomy for the treatment of one or two level lumbar stenosis from L1-L5 that requires surgical decompression, and in patients with at least moderate impairment in function, who experience relief in flexion from their symptoms of leg/buttocks/groin pain, with or without back pain, and who have undergone at least 1 epidural steroid injection and at least 6 months of conservative treatment.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. At least moderate lumbar stenosis from L1-L5, at one or two contiguous levels, confirmed by MRI or CT, with up to Grade I spondylolisthesis.
  2. Radiographic confirmation of no angular or translatory instability of the spine at index or adjacent levels.
  3. VAS back pain score of at least 50mm on a 100mm scale.
  4. Neurogenic claudication as defined by leg/buttocks or groin pain that can be relieved by flexion.
  5. At least one epidural injection at any prior timepoint, and at least 6 months of prior conservative care without adequate and sustained symptom relief.
  6. 40 to 80 years of age.
  7. Minimum baseline Oswestry score of 40% (20/50).
  8. Appropriate candidate for treatment using posterior surgical approach.

Exclusion Criteria:

  1. More than two vertebral levels requiring surgical decompression.
  2. Prior surgical procedure resulting in translatory instability of the lumbar spine.
  3. More than one surgical procedure at any combination of lumbar levels.
  4. Prior fusion, implantation of a total disc replacement, complete laminectomy, or implantation of an interspinous process device at any lumbar level.
  5. Radiographically compromised vertebral body at any lumbar level caused by current or past trauma or tumor.
  6. Severe facet hypertrophy requiring extensive bone removal which would cause instability.
  7. Isthmic spondylolisthesis or spondylolysis (pars fracture).
  8. Degenerative lumbar scoliosis (Cobb angle >25°).
  9. Lumbar disc herniation requiring surgical intervention.
  10. S.C.O.R.E. ≤6 suggestion of osteopenia or osteoporosis risk confirmed by DEXA T-score equal to or worse than -1.0.
  11. Back or leg pain of unknown etiology.
  12. Axial back pain only, with no leg, buttock or groin pain.
  13. Morbid obesity as defined by BMI >40.
  14. Pregnant or interested in becoming pregnant in the next three years.
  15. Known allergy to titanium, titanium alloys or MR contrast agents.
  16. Active or chronic infection - systemic or local.
  17. Chronic use of medications or any drug known to potentially interfere with bone/soft tissue healing (e.g. steroids), not including Medrol DosePak.
  18. History of significant peripheral neuropathy.
  19. Significant peripheral vascular disease.
  20. Unremitting back pain in any position.
  21. Uncontrolled diabetes.
  22. Known history of Paget's disease, osteomalacia, or any other metabolic bone disease.
  23. Cauda equina syndrome.
  24. Fixed and complete motor, sensory, or reflex deficit.
  25. Rheumatoid arthritis or other autoimmune disease.
  26. History of AIDS, HIV or active Hepatitis.
  27. History of invasive malignancy (except non-melanoma skin cancer) within at least five years.
  28. History of substance abuse.
  29. Current involvement in a study of another investigational product for similar purpose.
  30. Currently seeking or receiving workman's compensation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00534235

Contacts
Contact: coflex Spine Study coflexstudy@paradigmspine.com

Locations
United States, Arizona
Recruiting
Phoenix, Arizona, United States
United States, California
Recruiting
Colton, California, United States
Recruiting
Irvine, California, United States
Recruiting
Los Angeles, California, United States
Recruiting
Rancho Mirage, California, United States
Recruiting
San Diego, California, United States
United States, Colorado
Recruiting
Loveland, Colorado, United States
United States, Florida
Recruiting
Sarasota, Florida, United States
Recruiting
Tampa, Florida, United States
United States, Maryland
Recruiting
Baltimore, Maryland, United States
United States, Massachusetts
Recruiting
Newton, Massachusetts, United States
United States, Michigan
Recruiting
Royal Oak, Michigan, United States
United States, Nevada
Recruiting
Las Vegas, Nevada, United States
United States, New York
Recruiting
New York, New York, United States
United States, Oregon
Recruiting
Bend, Oregon, United States
United States, Texas
Recruiting
Austin, Texas, United States
Recruiting
Dallas, Texas, United States
Recruiting
San Antonio, Texas, United States
Recruiting
Sherman, Texas, United States
Recruiting
Tyler, Texas, United States
Sponsors and Collaborators
Paradigm Spine
Investigators
Study Director: Paradigm Spine Paradigm Spine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00534235     History of Changes
Other Study ID Numbers: PS-001
Study First Received: September 20, 2007
Last Updated: June 2, 2009
Health Authority: United States: Food and Drug Administration;   United States: Institutional Review Board

Keywords provided by Paradigm Spine:
back
pain
lumbar
stenosis
spine
spinal
back pain
low back pain
lumbar pain
spinal stenosis
lumbar stenosis
lumbar spinal stenosis
canal stenosis
spinal canal stenosis
lumbar canal stenosis
central canal stenosis
spinal canal
pinched nerve
pinched nerves
pinched nerve root
pinched nerve roots

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

ClinicalTrials.gov processed this record on February 09, 2012