BMAC & Allograft vs BMP-2

• Sponsor: NYU Langone Health (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02924571
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 53.3
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The aim of this investigation is to compare the use of bone marrow aspirate concentrate (BMAC) and allograft versus to recombinant human bone morphogenetic protein-2 (BMP) in subjects undergoing elective thoracolumbar spinal fusion with interbody support. The investigators will look at the safety and efficacy of these two different surgical methods by assessing surgery outcomes and participants' quality of life.

Condition or Disease	Intervention/Treatment	Phase
Spinal Fusion	Procedure: Bone Marrow Aspirate Concentrate (BMAC); Procedure: Recombinant Human Bone Morphogenetic Protein-2 (BMP)	N/A

Detailed Description

Currently, there are many available orthopaedic graft adjuncts which each have their own advantages and disadvantages. For example, although effective, BMPs are very expensive and have a risk of side effects. The use of BMAC may be a good alternative to the use of BMPs, and may not have the same side effects.

Subjects who are scheduled for an elective spinal fusion and are enrolled in the study will be assigned to receive either BMP or BMAC. Subjects will be asked to complete questionnaires relating to quality of life, use of pain killers, and overall health, as well as have standard radiographic studies to examine the spine pre- and post-surgically. Subjects will attend 7 visits, which happen at the same time as the standard of care visits they would normally attend for their condition. Subjects will be followed in the study for 2 years in total.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: Jul 24, 2018
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bone Marrow Aspirate Concentrate (BMAC)	Procedure: Bone Marrow Aspirate Concentrate (BMAC); Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest (BMAC+ ALLOGRAFT) or
Active Comparator: Recombinant Human Bone Morphogenetic Protein-2 (BMP)	Procedure: Recombinant Human Bone Morphogenetic Protein-2 (BMP); INFUSE rhBMP-2 Bone Graft (BMP). Using the standard technique for anterior lateral fusion, the bone graft from group 1 or 2 will be laid onto the decorticated transverse processes, lateral aspects of the facets, par interarticularis, and onto the facets.; Other Names: rhBMP-2

Outcome Measures

Primary Outcome Measures

1. Oswestry Disability Index (ODI) [Baseline to 2 Years]

   Differences from pre-operative visit to post-operative time points will be compared between BMAC and BMP groups by Student t-tests.

2. SF-12 (Short Form Health Survey) [Baseline to 2 Years]

   Differences from pre-operative visit to post-operative time points will be compared between BMAC and BMP groups by Student t-tests.

3. Numeric Pain Rating Scale (NRS) [Baseline to 2 Years]

   Differences from pre-operative visit to post-operative time points will be compared between BMAC and BMP groups by Student t-tests.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

• Principal Investigator: Peter Passias, NYU Langone Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT02924571
• Other Study ID Numbers: 16-01160
• First Posted: Oct 5, 2016
• Last Update Posted: Oct 13, 2021
• Last Verified: Oct 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Study Results

No Results Posted as of Oct 13, 2021