Status:
ACTIVE_NOT_RECRUITING
Prospective Study of Thoracolumbar Spinal Fusion Graft
Lead Sponsor:
NYU Langone Health
Conditions:
Lumbar Degenerative Disc Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is a single-center, prospective randomized clinical study intended to compare and evaluate the efficacy of subjects who are treated with bone marrow aspirate concentrate (BMAC) and allograf...
Detailed Description
Subjects who are candidates for posterior lumbar or lumbosacral spinal fusion without anterior interbody support will be screened for inclusion in the study. Participants will be enrolled and randomiz...
Eligibility Criteria
Inclusion
- Must be 18 years old or older
- Scheduled for elective posterior spinal fusion of the thoracolumbar spine or lumbar spine with or without anterior interbody support
- Failed at least 6 weeks of conservative care
- ODI v2.1 score \> 30%
- No contraindication to BMAC (as per manufacturer)
- Signed consent form
Exclusion
- Spondylolisthesis grade ≥ 3
- Pagets disease, osteomalacia, or any metabolic bone disease
- Use of medications that interfere with bone healing (chronic steroids)
- Patient unlikely to comply with post-op schedule with physician
- Recent history of chemical dependency
- Participation in other investigational device trial(s) within past 30 days
- Active malignancy
- Pregnancy or planning to become pregnant
- Direct involvement in execution of this protocol
Key Trial Info
Start Date :
August 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT02297256
Start Date
August 1 2012
End Date
December 1 2025
Last Update
September 3 2024
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
NYU Hospital for Joint Diseases
New York, New York, United States, 10003
2
Center for Musculoskeletal Care (CMC)
New York, New York, United States, 10016
3
NY Spine Institute
Westbury, New York, United States, 11590