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

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.
 
ClinicalTrials.gov Identifier: NCT00984672
Recruitment Status : Active, not recruiting
First Posted : September 25, 2009
Last Update Posted : April 3, 2020
Sponsor:
Information provided by (Responsible Party):
Ahmad Nassr, Mayo Clinic

Tracking Information
First Submitted Date September 23, 2009
First Posted Date September 25, 2009
Last Update Posted Date April 3, 2020
Study Start Date March 2009
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Radiculitis Following Use of Bone Morphogenetic Protein-2 for Interbody Arthrodesis in Spinal Surgery
Official Title Prospective Evaluation of Radiculitis Following Use of Bone Morphogenetic Protein-2 for Interbody Arthrodesis in Spinal Surgery
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).
Condition Lumbar Degenerative Disease
Intervention Not Provided
Study 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: March 4, 2019)
103
Original Estimated Enrollment
 (submitted: September 24, 2009)
240
Estimated Study Completion Date December 2020
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00984672
Other Study ID Numbers 08-008802
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ahmad Nassr, Mayo Clinic
Study Sponsor Mayo Clinic
Collaborators Not Provided
Investigators
Principal Investigator: Ahmad Nassr, M.D. Mayo Clinic
PRS Account Mayo Clinic
Verification Date April 2020