Clinical trial NCT02924571: BMAC & Allograft vs BMP-2
Official title: Prospective, Blinded, Non-randomized Study of Thoracolumbar Spinal Fusion Graft Efficacy: Bone Marrow Aspirate Concentrate and Allograft Versus Recombinant Bone Morphogenetic Protein-2 (BMP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Fusion
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-10-05
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this investigation is to compare the use of bone marrow aspirate concentrate (BMAC) and allograft versus recombinant human bone morphogenetic protein-2 (BMP) versus the gold standard fusion in subjects undergoing elective lumbar spinal fusion with interbody support. The safety and efficacy of the surgical interventions will be evaluated by assessing fusion status and subjects' quality of life outcomes.

Detailed description: This study will be a prospective, randomized clinical study at a single-center, NYU Langone Medical Center. It is intended to compare and evaluate the efficacy of subjects who are either treated with (1) bone marrow aspirate concentrate (BMAC) and allograft or (2) recombinant human bone morphogenetic protein-2 (BMP) or (3) autograft (control) during lumbar spinal fusion with interbody support. The clinical, radiographic, and Health Related Quality of Life (HRQOL) outcomes will be assessed in operatively treated adult spinal degenerative disease patients undergoing lumbar spinal fusion.

Eligibility criteria: Inclusion Criteria:

* Must be 18 years old or older
* Scheduled for elective posterior or anterior and posterior spinal fusion of the thoracolumbar spine with or without anterior interbody support
* Failed at least 6 weeks of conservative care
* No contraindication to BMAC (as per manufacturer)
* Signed consent form

Exclusion criteria:

* Prior lumbar fusion surgery at operative level (prior discectomy and/or laminectomy allowed)
* Incompetent or missing anterior arch at the affected level (e.g. laminectomy, pars defect)
* Currently requires laminectomy at level of surgery
* Facet joints at implant level are absent or fractured
* Post-traumatic vertebral body compromise or acute fracture at implant level
* Body mass Index (BMI) \> 40
* Known allergy to titanium
* Paget's disease, osteomalacia, or any other metabolic bone disease
* Use of medications or any drug known to potentially interfere with bone/soft tissue healing (e.g. chronic systemic steroids)
* Unlikely to comply with the follow-up evaluation schedule
* Active malignancy defined as history of invasive malignancy, except if the subject has received treatment and displayed no clinical signs and symptoms for at least five years
* Pregnant or planning to become pregnant during the length of study participation

Primary outcomes:
measure: Number of Participants with Successful Fusion Status at Month 12 Post-Procedure
timeFrame: Month 12 Post-Operation
measure: Oswestry Disability Index (ODI) Score at Pre-Op Visit
timeFrame: Pre-Operation Visit (Day 0)
measure: ODI Score at Week 6 Follow-Up
timeFrame: Week 6 Post-Operation
measure: ODI Score at Month 3 Follow-Up
timeFrame: Month 3 Post-Operation
measure: ODI Score at Month 6 Follow-Up
timeFrame: Month 6 Post-Operation
measure: ODI Score at Month 12 Follow-Up
timeFrame: Month 12 Post-Operation
measure: ODI Score at Month 24 Follow-Up
timeFrame: Month 24 Post-Operation
measure: Numeric Rating Scale (NRS) - Back Pain Score at Pre-Op Visit
timeFrame: Pre-Operation Visit (Day 0)
measure: NRS - Back Pain Score at Week 6 Follow-Up
timeFrame: Week 6 Post-Operation
measure: NRS - Back Pain Score at Month 3 Follow-Up
timeFrame: Month 3 Post-Operation
measure: NRS - Back Pain Score at Month 6 Follow-Up
timeFrame: Month 6 Post-Operation
measure: NRS - Back Pain Score at Month 12 Follow-Up
timeFrame: Month 12 Post-Operation
measure: NRS - Back Pain Score at Month 24 Follow-Up
timeFrame: Month 24 Post-Operation
measure: Short Form 12 (SF-12) - Physical Component Summary (PCS) Score at Pre-Op Visit
timeFrame: Pre-Operation Visit (Day 0)
measure: SF-12 - PCS Score at Week 6 Follow-Up
timeFrame: Week 6 Post-Operation
measure: SF-12 - PCS Score at Month 3 Follow-Up
timeFrame: Month 3 Post-Operation
measure: SF-12 - PCS Score at Month 6 Follow-Up
timeFrame: Month 6 Post-Operation
measure: SF-12 - PCS Score at Month 12 Follow-Up
timeFrame: Month 12 Post-Operation
measure: SF-12 - PCS Score at Month 24 Follow-Up
timeFrame: Month 24 Post-Operation
measure: SF-12 - Mental Component Summary (MCS) Score at Pre-Op Visit
timeFrame: Pre-Operation Visit (Day 0)
measure: SF-12 - MCS Score at Week 6 Follow-Up
timeFrame: Week 6 Post-Operation
measure: SF-12 - MCS Score at Week 12 Follow-Up
timeFrame: Week 12 Post-Operation
measure: SF-12 - MCS Score at Week 24 Follow-Up
timeFrame: Week 24 Post-Operation
measure: Euro-Qol 5-Dimension (EQ-5D) Score at Pre-Op Visit
timeFrame: Pre-Operation Visit (Day 0)
measure: EQ-5D Score at Week 6 Follow-Up
timeFrame: Week 6 Post-Operation
measure: EQ-5D Score at Month 3 Follow-Up
timeFrame: Month 3 Post-Operation
measure: EQ-5D Score at Month 6 Follow-Up
timeFrame: Month 6 Post-Operation
measure: EQ-5D Score at Month 12 Follow-Up
timeFrame: Month 12 Post-Operation
measure: EQ-5D Score at Month 24 Follow-Up
timeFrame: Month 24 Post-Operation
measure: Pain Catastrophizing Scale (PCS) Score at Pre-Op Visit
timeFrame: Pre-Operation Visit (Day 0)
measure: PCS Score at Week 6 Follow-Up
timeFrame: Week 6 Post-Operation
measure: PCS Score at Month 3 Follow-Up
timeFrame: Month 3 Post-Operation
measure: PCS Score at Month 6 Follow-Up
timeFrame: Month 6 Post-Operation
measure: PCS Score at Month 12 Follow-Up
timeFrame: Month 12 Post-Operation
measure: PCS Score at Month 24 Follow-Up
timeFrame: Month 24 Post-Operation
measure: Patient Reported Outcome Measure Information System (PROMIS) Item Bank v1.1 - Pain Interference Score at Pre-Op Visit
timeFrame: Pre-Operation Visit (Day 0)
measure: PROMIS Item Bank v1.1 - Pain Interference Score at Week 6 Follow-Up
timeFrame: Week 6 Post-Operation
measure: PROMIS Item Bank v1.1 - Pain Interference Score at Month 3 Follow-Up
timeFrame: Month 3 Post-Operation
measure: PROMIS Item Bank v1.1 - Pain Interference Score at Month 6 Follow-Up
timeFrame: Month 6 Post-Operation
measure: PROMIS Item Bank v1.1 - Pain Interference Score at Month 12 Follow-Up
timeFrame: Month 12 Post-Operation
measure: PROMIS Item Bank v1.1 - Pain Interference Score at Month 24 Follow-Up
timeFrame: Month 24 Post-Operation
measure: PROMIS Scale v1.0 - Pain Intensity 3a Score at Pre-Op Visit
timeFrame: Pre-Operation Visit (Day 0)
measure: PROMIS Scale v1.0 - Pain Intensity 3a Score at Week 6 Follow-Up
timeFrame: Week 6 Post-Operation
measure: PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 3 Follow-Up
timeFrame: Month 3 Post-Operation
measure: PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 6 Follow-Up
timeFrame: Month 6 Post-Operation
measure: PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 12 Follow-Up
timeFrame: Month 12 Post-Operation
measure: PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 24 Follow-Up
timeFrame: Month 24 Post-Operation
measure: PROMIS Bank v1.2 - Physical Function Score at Pre-Op Visit
timeFrame: Pre-Operation Visit (Day 0)
measure: PROMIS Bank v1.2 - Physical Function Score at Week 6 Follow-Up
timeFrame: Week 6 Post-Operation
measure: PROMIS Bank v1.2 - Physical Function Score at Month 3 Follow-Up
timeFrame: Month 3 Post-Operation
measure: PROMIS Bank v1.2 - Physical Function Score at Month 6 Follow-Up
timeFrame: Month 6 Post-Operation
measure: PROMIS Bank v1.2 - Physical Function Score at Month 12 Follow-Up
timeFrame: Month 12 Post-Operation
measure: PROMIS Bank v1.2 - Physical Function Score at Month 24 Follow-Up
timeFrame: Month 24 Post-Operation
measure: PROMIS Bank v2.0 - Mobility Score at Pre-Op Visit
timeFrame: Pre-Operation Visit (Day 0)
measure: PROMIS Bank v2.0 - Mobility Score at Week 6 Follow-Up
timeFrame: Week 6 Post-Operation
measure: PROMIS Bank v2.0 - Mobility Score at Month 3 Follow-Up
timeFrame: Month 3 Post-Operation
measure: PROMIS Bank v2.0 - Mobility Score at Month 6 Follow-Up
timeFrame: Month 6 Post-Operation
measure: PROMIS Bank v2.0 - Mobility Score at Month 12 Follow-Up
timeFrame: Month 12 Post-Operation
measure: PROMIS Bank v2.0 - Mobility Score at Month 24 Follow-Up
timeFrame: Month 24 Post-Operation
measure: Length of Operation
timeFrame: Intraoperative Period (Day 0) (typically between 2-7 hours)
measure: Length of Hospital Stay
timeFrame: From admission up to discharge (Up to Year 2 Post-Operation)
measure: Blood Loss During Procedure
timeFrame: Intraoperative Period (Day 0) (typically between 2-7 hours)
measure: Number of Participants using Non-Prescription, Over-the-Counter (OTC) Drugs at Pre-Op Visit
timeFrame: Pre-Operation Visit (Day 0)
measure: Number of Participants using Non-Prescription, OTC Drugs at Week 6 Follow-Up
timeFrame: Week 6 Post-Operation
measure: Number of Participants using Non-Prescription, OTC Drugs at Month 3 Follow-Up
timeFrame: Month 3 Post-Operation
measure: Number of Participants using Non-Prescription, OTC Drugs at Month 6 Follow-Up
timeFrame: Month 6 Post-Operation
measure: Number of Participants using Non-Prescription, OTC Drugs at Month 12 Follow-Up
timeFrame: Month 12 Post-Operation
measure: Number of Participants using Non-Prescription, OTC Drugs at Month 24 Follow-Up
timeFrame: Month 24 Post-Operation
measure: Number of Participants with Surgical Complications during Operation
timeFrame: Intraoperative Period (Day 0) (typically between 2-7 hours)
measure: Number of Participants with Surgical Complications at Week 6 Follow-Up
timeFrame: Week 6 Post-Operation
measure: Number of Participants with Surgical Complications at Month 3 Follow-Up
timeFrame: Month 3 Post-Operation
measure: Number of Participants with Surgical Complications at Month 6 Follow-Up
timeFrame: Month 6 Post-Operation
measure: Number of Participants with Surgical Complications at Month 12 Follow-Up
timeFrame: Month 12 Post-Operation
measure: Number of Participants with Surgical Complications at Month 24 Follow-Up
timeFrame: Month 24 Post-Operation
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Medical Center
name: Peter Passias
role: PRINCIPAL_INVESTIGATOR
References: