N/A N=59 Randomized Single-blind Treatment

BMAC & Allograft vs BMP-2

Spinal Fusion

Bottom Line

View on ClinicalTrials.gov: NCT02924571 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2025

Primary outcome: Primary: Number of Participants With Successful Fusion Status at Month 12 Post-Procedure — 17; 16; 16 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Bone Marrow Aspirate Concentrate (BMAC) + Allograft (Device); Recombinant Human Bone Morphogenetic Protein-2 (BMP) (Device); Autograft (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: NYU Langone Health
Primary completion: Jun 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Successful Fusion Status at Month 12 Post-Procedure	17; 16; 16	—
PRIMARY Oswestry Disability Index (ODI) Score at Pre-Op Visit	64.8; 66.1; 60.2	—
PRIMARY ODI Score at Week 6 Follow-Up	43.5; 40.2; 44.6	—
PRIMARY ODI Score at Month 3 Follow-Up	41.1; 40.6; 41.8	—
PRIMARY ODI Score at Month 6 Follow-Up	38.2; 40.3; 40.5	—
PRIMARY ODI Score at Month 12 Follow-Up	34.2; 36.5; 36.8	—
PRIMARY ODI Score at Month 24 Follow-Up	28.6; 30.5; 30.9	—
PRIMARY Numeric Rating Scale (NRS) - Back Pain Score at Pre-Op Visit	8.1; 7.6; 8.2	—
PRIMARY NRS - Back Pain Score at Week 6 Follow-Up	5.3; 5.6; 4.9	—
PRIMARY NRS - Back Pain Score at Month 3 Follow-Up	4.8; 5.2; 4.7	—
PRIMARY NRS - Back Pain Score at Month 6 Follow-Up	4.7; 5; 4.7	—
PRIMARY NRS - Back Pain Score at Month 12 Follow-Up	4.2; 4.6; 4.4	—
PRIMARY NRS - Back Pain Score at Month 24 Follow-Up	4; 4.1; 4.1	—
PRIMARY Short Form 12 (SF-12) - Physical Component Summary (PCS) Score at Pre-Op Visit	42.5; 47.6; 45.8	—
PRIMARY SF-12 - PCS Score at Week 6 Follow-Up	44.5; 48.4; 47.2	—
PRIMARY SF-12 - PCS Score at Month 3 Follow-Up	44.5; 48.4; 47.2	—
PRIMARY SF-12 - PCS Score at Month 6 Follow-Up	49.5; 50.1; 48.8	—
PRIMARY SF-12 - PCS Score at Month 12 Follow-Up	64.2; 61.6; 62.8	—
PRIMARY SF-12 - PCS Score at Month 24 Follow-Up	69.4; 67.7; 70.2	—
PRIMARY SF-12 - Mental Component Summary (MCS) Score at Pre-Op Visit	51.9; 53.4; 55.1	—
PRIMARY SF-12 - MCS Score at Week 6 Follow-Up	58.6; 57.5; 58.1	—
PRIMARY SF-12 - MCS Score at Month 3 Follow-Up	58.9; 57.7; 57.8	—
PRIMARY SF-12 - MCS Score at Month 6 Follow-Up	63.1; 65.5; 65.2	—
PRIMARY Euro-Qol 5-Dimension (EQ-5D) Score at Pre-Op Visit	10; 11; 10.5	—
PRIMARY EQ-5D Score at Week 6 Follow-Up	8.4; 8.1; 9	—
PRIMARY EQ-5D Score at Month 3 Follow-Up	8; 7.9; 8.3	—
PRIMARY EQ-5D Score at Month 6 Follow-Up	7.6; 7.1; 7.8	—
PRIMARY EQ-5D Score at Month 12 Follow-Up	6.9; 7; 7.4	—
PRIMARY EQ-5D Score at Month 24 Follow-Up	7.1; 7.4; 7	—
PRIMARY Pain Catastrophizing Scale (PCS) Score at Pre-Op Visit	33.6; 35.2; 35.4	—
PRIMARY PCS Score at Week 6 Follow-Up	30.4; 29.6; 31.1	—
PRIMARY PCS Score at Month 3 Follow-Up	21.5; 25.8; 25.2	—
PRIMARY PCS Score at Month 6 Follow-Up	20.6; 22.2; 20.4	—
PRIMARY PCS Score at Month 12 Follow-Up	17.3; 19.8; 20.1	—
PRIMARY PCS Score at Month 24 Follow-Up	11.3; 14.3; 15.1	—
PRIMARY Patient Reported Outcome Measure Information System (PROMIS) Item Bank v1.1 - Pain Interference Score at Pre-Op Visit	63.2; 65.1; 60.2	—
PRIMARY PROMIS Item Bank v1.1 - Pain Interference Score at Week 6 Follow-Up	54.3; 51.1; 55.5	—
PRIMARY PROMIS Item Bank v1.1 - Pain Interference Score at Month 3 Follow-Up	50.8; 49.7; 51.4	—
PRIMARY PROMIS Item Bank v1.1 - Pain Interference Score at Month 6 Follow-Up	47.4; 47.6; 49.3	—
PRIMARY PROMIS Item Bank v1.1 - Pain Interference Score at Month 12 Follow-Up	41.3; 43.7; 43.5	—
PRIMARY PROMIS Item Bank v1.1 - Pain Interference Score at Month 24 Follow-Up	33.8; 32.9; 35.4	—
PRIMARY PROMIS Scale v1.0 - Pain Intensity 3a Score at Pre-Op Visit	68.7; 69.5; 70.4	—
PRIMARY PROMIS Scale v1.0 - Pain Intensity 3a Score at Week 6 Follow-Up	61.3; 62.4; 60.1	—
PRIMARY PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 3 Follow-Up	52.8; 51.9; 54.2	—
PRIMARY PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 6 Follow-Up	50.6; 51.3; 52.8	—
PRIMARY PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 12 Follow-Up	33.2; 35.5; 38.6	—
PRIMARY PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 24 Follow-Up	25.3; 20.1; 23.4	—
PRIMARY PROMIS Bank v1.2 - Physical Function Score at Pre-Op Visit	58.9; 60.3; 54.3	—
PRIMARY PROMIS Bank v1.2 - Physical Function Score at Week 6 Follow-Up	50.1; 52.6; 51.1	—
PRIMARY PROMIS Bank v1.2 - Physical Function Score at Month 3 Follow-Up	48.3; 47.7; 46.5	—
PRIMARY PROMIS Bank v1.2 - Physical Function Score at Month 6 Follow-Up	43.6; 44.9; 42.2	—
PRIMARY PROMIS Bank v1.2 - Physical Function Score at Month 12 Follow-Up	39.7; 42.4; 40	—
PRIMARY PROMIS Bank v1.2 - Physical Function Score at Month 24 Follow-Up	34.1; 37.3; 38	—
PRIMARY PROMIS Bank v2.0 - Mobility Score at Pre-Op Visit	62.1; 60.7; 64.3	—
PRIMARY PROMIS Bank v2.0 - Mobility Score at Week 6 Follow-Up	53.6; 55; 56.7	—
PRIMARY PROMIS Bank v2.0 - Mobility Score at Month 3 Follow-Up	49.8; 51.1; 53	—
PRIMARY PROMIS Bank v2.0 - Mobility Score at Month 6 Follow-Up	47.2; 49.3; 49.8	—
PRIMARY PROMIS Bank v2.0 - Mobility Score at Month 12 Follow-Up	42.7; 44; 44.8	—
PRIMARY PROMIS Bank v2.0 - Mobility Score at Month 24 Follow-Up	39.5; 41.1; 43	—
PRIMARY Length of Operation	324.6; 354.4; 315.7	—
PRIMARY Length of Hospital Stay	7.1; 8; 7.3	—
PRIMARY Blood Loss During Procedure	845.3; 866.1; 833.6	—
PRIMARY Number of Participants Using Non-Prescription, Over-the-Counter (OTC) Drugs at Pre-Op Visit	20; 20; 19	—
PRIMARY Number of Participants Using Non-Prescription, OTC Drugs at Week 6 Follow-Up	20; 20; 19	—
PRIMARY Number of Participants Using Non-Prescription, OTC Drugs at Month 3 Follow-Up	17; 18; 18	—
PRIMARY Number of Participants Using Non-Prescription, OTC Drugs at Month 6 Follow-Up	10; 12; 15	—
PRIMARY Number of Participants Using Non-Prescription, OTC Drugs at Month 12 Follow-Up	9; 11; 12	—
PRIMARY Number of Participants Using Non-Prescription, OTC Drugs at Month 24 Follow-Up	6; 8; 8	—
PRIMARY Number of Participants With Surgical Complications During Operation	0; 0; 0	—
PRIMARY Number of Participants With Surgical Complications at Week 6 Follow-Up	0; 0; 0	—
PRIMARY Number of Participants With Surgical Complications at Month 3 Follow-Up	0; 0; 0	—
PRIMARY Number of Participants With Surgical Complications at Month 6 Follow-Up	0; 0; 0	—
PRIMARY Number of Participants With Surgical Complications at Month 12 Follow-Up	3; 4; 3	—
PRIMARY Number of Participants With Surgical Complications at Month 24 Follow-Up	3; 4; 3	—
PRIMARY SF-12 - MCS Score at Month 12 Follow-Up	69.4; 67.7; 68.8	—
PRIMARY SF-12 - MCS Score at Month 24 Follow-Up	74.2; 75.6; 75.2	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02924571). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.