Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02297256
Other study ID # 12-02411
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 2012
Est. completion date December 1, 2025

Study information

Verified date September 2023
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 allograft to iliac crest bone grafts (ICBG) during posterior lumbar/lumbosacral spinal fusion.


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 randomized to either the BMAC + allograft or ICBG group. An enrollment ratio of two BMAC + allograft to one ICBG subject (2:1) for up to a total of 40 subjects will be enrolled in the study which also accounts for failed screening subjects. The study will determine and compare differences in fusion rate and health related quality of life parameters at 6 weeks, 3 months, 6 months, 1 year, and 2 years postoperatively.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 17
Est. completion date December 1, 2025
Est. primary completion date November 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Criteria: - 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

Study Design


Intervention

Procedure:
BMAC & Allograft
Use of Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest during posterior lumbar/lumbosacral spinal fusion.
Iliac Crest Bone Graft
Use of iliac crest bone grafts (ICBG) during posterior lumbar/lumbosacral spinal fusion.

Locations

Country Name City State
United States Center for Musculoskeletal Care (CMC) New York New York
United States NYU Hospital for Joint Diseases New York New York
United States NY Spine Institute Westbury New York

Sponsors (1)

Lead Sponsor Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

References & Publications (2)

Asahara T, Masuda H, Takahashi T, Kalka C, Pastore C, Silver M, Kearne M, Magner M, Isner JM. Bone marrow origin of endothelial progenitor cells responsible for postnatal vasculogenesis in physiological and pathological neovascularization. Circ Res. 1999 Aug 6;85(3):221-8. doi: 10.1161/01.res.85.3.221. — View Citation

Gan Y, Dai K, Zhang P, Tang T, Zhu Z, Lu J. The clinical use of enriched bone marrow stem cells combined with porous beta-tricalcium phosphate in posterior spinal fusion. Biomaterials. 2008 Oct;29(29):3973-82. doi: 10.1016/j.biomaterials.2008.06.026. Epub 2008 Jul 18. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary CT scan to assess fusion status Pre-operative, Post Operative 1 Year
Primary Oswestry Disability Index (ODI) Pre-operative, Post Operative 1 Year
Primary Short Form Health Survey (SF-12) Pre-op, Post Operative 1 Year
Primary Numeric Pain Rating Scale Pre-op, Post Operative 1 Year
Primary Length of Stay Post Operative 1 Year
See also
  Status Clinical Trial Phase
Completed NCT01198470 - TRIUMPH Lumbar Artificial Disc IDE: A Pilot Study N/A
Terminated NCT00744861 - Ultrasound as Adjunct Therapy for Increasing Fusion Success After Lumbar Surgery N/A
Completed NCT00949936 - Safety and Performance Study of the CAdiscTM-L Lumbar Spinal Disc Replacement Device For CE Marking N/A
Completed NCT03974711 - Rampart Duo Clinical (RaDical) Post-Market Study
Recruiting NCT01721889 - Radiostereometric Analysis of Spine Arthrodesis N/A
Terminated NCT02139527 - CARES Lumbar Artificial Disc Registry Phase 4
Terminated NCT00878579 - Percutaneous Dynamic Stabilization (PDS) System Versus Fusion for Treating Degenerative Disc Disease Phase 2
Completed NCT01640977 - A Prospective Non-concurrent Controlled Evaluation of Open and MAS® PLIF N/A
Terminated NCT01689922 - The Effectiveness of Anti-Gravity Treadmill Training N/A
Enrolling by invitation NCT02529566 - Human Autograft Mesenchymal Stem Cell Mediated Stabilization of The Degenerative Lumbar Spine N/A
Completed NCT02347410 - Spineology Clinical Outcomes Trial: An IDE Investigation N/A
Terminated NCT02070484 - Human Amniotic Tissue-derived Allograft, NuCel, in Posteriolateral Lumbar Fusions for Degenerative Disc Disease N/A
Terminated NCT01293981 - Radiographic and Clinical Outcomes of PureGen in Posterior Lumbar (PLIF) and Transforaminal Interbody Fusion (TLIF) N/A
Terminated NCT01294007 - Radiographic Analysis Using PureGen Versus Autologous Bone in Posterolateral Fusion (PLF) N/A
Terminated NCT00640029 - Evaluation of the Prosthetic Disc Replacement N/A
Terminated NCT00456378 - Study of the Safety and Effectiveness of DIAMâ„¢ Spinal Stabilization System Versus Conservative Care N/A
Completed NCT03647501 - Lumbar Fusion With Nexxt Spine 3D-Printed Titanium Interbody Cages N/A
Recruiting NCT05516992 - Moderate - Severe Degenerative Disc Disease Evaluation of the Lumbar Spine Phase 3
Completed NCT01323387 - Lumbar Degenerative Disc Disease Treated With Anterior Tension Band System (ATB) With ALIF/FRA Spacer N/A