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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00984672
Other study ID # 08-008802
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2009
Est. completion date April 21, 2016

Study information

Verified date April 2022
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 103
Est. completion date April 21, 2016
Est. primary completion date April 21, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

See also
  Status Clinical Trial Phase
Completed NCT03679494 - Effectiveness of Implementing Shared Decision-Making on Quality of Care Among Patients With Lumbar Degenerative Diseases. N/A
Enrolling by invitation NCT06075966 - The Study of INTRA Spine Non Fusion Technique in the Treatment of Lumbar Degenerative Disease N/A
Recruiting NCT04120532 - Effects of Health Education for Patients Received Minimally Invasive Lumbar Spinal Surgery N/A

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