Evaluation of Radiculitis Following Use of Bone Morphogenetic Protein-2 for Interbody Arthrodesis in Spinal Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Ahmad Nassr, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00984672
First received: September 23, 2009
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

Clinician directed use of bone morphogenetic proteins (BMPs) in ways other than FDA approved, has increased recently due to the morbidity associated with harvest of iliac crest bone graft in spinal arthrodesis procedures. FDA approved for the use in anterior lumbar fusions with LT Cage, other clinical applications of these proteins is becoming widely adopted due to their effectiveness in forming bone and facilitating fusion. Clinicians have realized while these proteins are potent stimulators of bone formation there have been anecdotal reports of increased rates of radicular pain in the postoperative period when used in interbody arthrodesis procedures. Speculation as to the mechanism of this radiculitis is postulated to be due to the inflammatory effects of these proteins. Excess bone overgrowth around the spinal nerves in proximity to the fusion cage has been reported. No prospective studies have been performed assessing the incidence and etiology of this complication. The investigators propose a prospective study evaluating the incidence of this complication as well as postoperative imaging studies to help determine whether bony overgrowth is indeed occurring adjacent to the effected spinal nerves.


Condition
Lumbar Degenerative Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prospective Evaluation of Radiculitis Following Use of Bone Morphogenetic Protein-2 for Interbody Arthrodesis in Spinal Surgery

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Estimated Enrollment: 240
Study Start Date: March 2009
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Bone morphogenetic protein within an interbody cage
Transforaminal Lumbar Interbody Fusion with the use of BMP
Other bone grafting techniques within cage (non-BMP)
Use of iliac crest autograft, allograft, or local autogenous bone grafting within the cage during Transforaminal Lumbar Interbody Fusion.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients age 18-75 with lumbar degenerative conditions including degenerative disk disease, spondylolisthesis with significant back and or leg complaints that have failed greater than 6 weeks of conservative therapy that are felt to be candidates for posterior lumbar instrumented fusion with transforaminal interbody fusion (TLIF).

Criteria

Inclusion Criteria:

  • male or female age 18-75
  • candidate for TLIF
  • Lumbar levels L1-S1

Exclusion Criteria:

  • more than 3 TLIF levels
  • had a previous fusion attempt at involved level(s)
  • had more than 2 previous open, lumbar spine procedures at the involved level(s)
  • currently implanted with anterior instrumentation at the involved level(s)
  • BMI >40
  • active localized or systemic infection
  • presence of a disease entity or condition which significantly affects the possibility of bony fusion
  • has immunosuppressive disorder actively requiring treatment
  • pregnant or interested in becoming pregnant during the study
  • has a known sensitivity to device materials
  • mentally incompetent or is a prisoner
  • currently a participant in another study for the same indications
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00984672

Contacts
Contact: Vickie M. Treder, LPN 507-538-3561 treder.vickie@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Vickie M. Treder, LPN    507-538-3561    treder.vickie@mayo.edu   
Principal Investigator: Ahmad Nassr, M.D.         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Ahmad Nassr, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Ahmad Nassr, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00984672     History of Changes
Other Study ID Numbers: 08-008802
Study First Received: September 23, 2009
Last Updated: February 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Lumbar Degenerative Disease
Bone Morphogenetic Protein
TLIF

Additional relevant MeSH terms:
Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 28, 2014