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

NCT01316211 | Completed Results

• 1 other identifier: 06k004
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 8

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

Conditions

Spinal Stenosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in ODI From Baseline to 24 Months

  The ODI, also known as the Oswestry Low Back Pain Disability Questionnaire is a questionnaire providing information on back and leg pain and the affects on managing everyday life by dividing questions into 10 sections. For this study, the questions on sexual activity will not be asked. The total possible score for each section is 0-5. The scores are then converted percentages ranging from 0% (minimal disability) to 100% (maximum possible disability).

  Baseline, 3, 12, and 24 months

Secondary Outcomes (14)

• Number of Participants With Significant Migration or Expulsion of the Implant

  2 years

• Change in Visual Analog Scale (VAS) Back Pain From Baseline to 24 Months

  Baseline, 3, 12, and 24 months

• Change in Visual Analog Scale (VAS) Leg Pain From Baseline to 24 Months

  Baseline, 3, 12, and 24 months

• Neurological Status - Mean Change in Sensory Deficit From Baseline to 24 Months

  Baseline, 3, 12, and 24 months

• Assessment of Time to Symptoms Utilizing Walking Distance Test

  2 years

Study Arms (2)

coflex™

ACTIVE COMPARATOR

Implantation of coflex™ device in assigned patients

Device: Implantation of coflex™ after surgical decompression

Surgical decompression

ACTIVE COMPARATOR

Surgical decompression in patients with spinal stenosis without stabilization by an additional implant.

Procedure: Surgical decompression

Interventions

Implantation of coflex™ after surgical decompression DEVICE

The device will be implanted after surgical decompression in patients with spinal stenosis.

coflex™

Surgical decompression PROCEDURE

Surgical decompression in patients with spinal stenosis without stabilization by an additional implant

Surgical decompression

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Radiographic confirmation of no translatory instability in the main segment as well as in adjacent segments (dynamic translatory instability ≤ 3 mm).
• 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).
• Minimum of 3 months conservative therapy without improvement of symptoms.
• Age \>40 years.
• 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).
• Suitability of the patient for a posterior surgery procedure.
• 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.
• Personally signed informed consent form before the start of any study related procedures.

You may not qualify if:

• Any of the following will exclude a subject from the study:
• Preceding fusion or decompression surgery of the lumbar spine or preceding nucleotomy of the segments of concern (also if nucleotomy becomes necessary during surgery).
• 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)
• Isthmic and degenerative spondylolisthesis (anterolisthesis; retrolisthesis \> grade I) or spondylolysis (Pars fracture).
• Degenerative lumbar scoliosis (\> 25°).
• Adipositas (obesity). Defined as a body mass index \>40.
• Pregnancy, or wish to get pregnant during the course of the study.
• Known allergy for titanium and titanium alloys.
• Fluoride infections - both systemic and local.
• History of severe peripheral neuropathy.
• Significant peripheral vascular disease (claudication intermittens ≥ stage 2b).
• M. Paget or osteomalacia or other metabolic bone disorders.
• Cauda equina syndrome.
• Communicating diseases, including HIV, active hepatitis
• Patients who are lawfully kept in an institution.

Sponsors & Collaborators

• Paradigm Spine: lead
• MDT Medical Device Testing GmbH: collaborator
• MCRA: collaborator

Study Sites (8)

Oberlinklinik Potsdam Orthopädische Fachklinik

Potsdam, Brandenburg, 14482, Germany

Location

Orthopädische Universitätsklinik Frankfurt a.M.

Frankfurt a.M., Hesse, 60528, Germany

Location

Chirurgische Universitätsklinik Rostock Neurochirurgie

Rostock, Mecklenburg-Vorpommern, 18057, Germany

Location

Otto-von-Guericke-Universität Magdeburg Klinik für Orthopädie

Magdeburg, Saxony-Anhalt, 39120, Germany

Location

Ostseeklinik Damp Neurochirurgie

Damp, Schleswig-Holstein, 24351, Germany

Location

Klinik für Neurochirurgie Lübeck

Lübeck, Schleswig-Holstein, 23730, Germany

Location

Klinik für Wirbelsäulenchirurgie mit Skoliosezentrum Klinikum Neustadt

Neustadt, Schleswig-Holstein, 23730, Germany

Location

Klinikum Ingolstadt Neurochirurgie

Ingolstadt, 85049, Germany

Location

Related Publications (1)

• Schmidt S, Franke J, Rauschmann M, Adelt D, Bonsanto MM, Sola S. Prospective, randomized, multicenter study with 2-year follow-up to compare the performance of decompression with and without interlaminar stabilization. J Neurosurg Spine. 2018 Apr;28(4):406-415. doi: 10.3171/2017.11.SPINE17643. Epub 2018 Jan 26.

  PMID: 29372860 DERIVED

MeSH Terms

Conditions

Spinal Stenosis; Back Pain; Spinal Diseases; Low Back Pain

Interventions

Decompression, Surgical

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Results Point of Contact

• Title: Fran Magee, DVM
• Organization: Paradigm Spine

fran.magee@paradigmspine.com

212-367-7274

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2011
• First Posted: March 16, 2011
• Study Start: January 1, 2008
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: June 9, 2020
• Results First Posted: June 2, 2020

Record last verified: 2020-06

Locations

DE (8)