Lumbar Degenerative DiseaseNCT00984672
Evaluation of Radiculitis Following Use of Bone Morphogenetic Protein-2 for Interbody Arthrodesis in Spinal Surgery
An observational study of Lumbar Degenerative Disease, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lumbar Degenerative Disease
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to 21 Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- male or female age 18-75
- candidate for TLIF
- Lumbar levels L1-S1
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation of Radiculitis Following Use of Bone Morphogenetic Protein-2 for Interbody Arthrodesis in Spinal Surgery
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.
- Conditions
- Lumbar Degenerative Disease
- Keywords
- Lumbar Degenerative Disease, Bone Morphogenetic Protein, TLIF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2009 (estimated)
- Study startMar 2009
- Primary completion21 Apr 2016
- Study completion21 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Degenerative DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Nassr, Mayo Clinic
- Investigators
- Ahmad Nassr, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984672
- Sponsor's protocol ID
- 08-008802
- Status last verified
- Apr 2022
- First submitted
- 23 Sep 2009
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Radiculitis Following Use of Bone Morphogenetic Protein-2 for Interbody Arthrodesis in Spinal Surgery
- ClinicalTrials.gov ID
- NCT00984672
- Acronym / sponsor ID
- 08-008802
- Conditions
- Lumbar Degenerative Disease
- Keywords
- Lumbar Degenerative Disease, Bone Morphogenetic Protein, TLIF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- 21 Apr 2016 (actual)
- Study completion
- 21 Apr 2016 (actual)
- First posted
- 25 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- male or female age 18-75
- candidate for TLIF
- Lumbar levels L1-S1
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Lumbar Degenerative Disease
Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Recruiting
The NOTICE Study: Neurosurgery and OrThopedIcs Communication Evaluation Study Following Lumbar Fusions
Lumbar Spine Degeneration, Lumbar Spine Instability
Not yet recruitingObservational study
Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
Intervertebral Disc Degeneration
RecruitingObservational study
Thoracic-Lumbar Arthrodesis- Implanet Jazz
Spondylolisthesis, Spinal Stenosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmad Nassr, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Degenerative Disease, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2022.