BMAC & Allograft vs BMP-2

Spinal Fusion Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02924571
• Other study ID #: 16-01160
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 24, 2018
• Est. completion date: January 2025

Study information

• Verified date: February 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• 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 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

Related Conditions & MeSH terms

• Spinal Fusion

Intervention

Device:
• Bone Marrow Aspirate Concentrate (BMAC) + Allograft
Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest. Harvest BMAC System delivers high stem cell concentration to the graft site.
• Recombinant Human Bone Morphogenetic Protein-2 (BMP)
INFUSE rhBMP-2 Bone Graft used according to its approved FDA labels, both from an anterior approach using titanium cages as well as from a posterior interbody approach using polyetheretherketone (PEEK) cages.

Procedure:
• Autograft
Autograft with bone marrow aspirate.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Successful Fusion Status at 1 Year Post-Procedure	Fusion status assessed via CT scan by an independent radiologist.	Year 1
Primary	Change in Oswestry Disability Index (ODI) from Baseline	10-item self-report of how back pain has affected a participant's ability to manage everyday life. Items ranked on a 6-point Likert scale. The total score is the sum of responses; higher scores indicate higher levels of disability: 0 - 4 = No disability; 5 - 14 = Mild disability; 15 - 24 = Moderate disability; 25 - 34 = Severe disability; 35 - 50 = Completely disabled.	Baseline, Year 2
Primary	Change in Visual Analog Scale (VAS) Leg and Back Pain Scores from Baseline	Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain.	Baseline, Year 2
Primary	Change in Euro-Qol 5-Dimension (EQ-5D) Scores from Baseline	5-item self-report questionnaire. Each item describes a different aspect of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Participants rank items on a 3-point Likert scale from 1-3: 1 = no problems; 2 = some problems; 3 = extreme problems. The total score is the sum of responses and ranges from 5-15; lower scores indicate better overall health.	Baseline, Year 2
Primary	Change in Pain Catastrophizing Scale (PCS) from Baseline	Self-report questionnaire containing 13 items that describe different thoughts and feelings that may be associated with pain. Participants rank each item on a Likert scale from 0 (not at all) to 4 (all the time). Scores range from 0 to 52; lower scores indicate lower levels of catastrophic thinking related to pain.	Baseline, Year 2
Primary	Change in Patient Reported Outcome Measure Information System (PROMIS) Item Bank v1.1 - Pain Interference Scores from Baseline	40-item self-report assessing the negative effects of pain on functioning in the range experienced by the vast majority of people who have pain. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-160; lower scores indicate lower interference from pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10.	Baseline, Year 2
Primary	Change in PROMIS Scale v1.0 - Pain Intensity 3a Scores from Baseline	3-item self-report assessment of how much a participant hurts. Participants rank items on a 5-point Likert scale ranging from 0 (Had no pain) to 4 (Very severe). The raw score is the sum of responses and ranges from 0-12; lower scores indicate lower levels of pain. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10.	Baseline, Year 2
Primary	Change in PROMIS Bank v1.2 - Physical Function Scores from Baseline	120-item self-report assessment of physical health, physical function, pain, and fatigue. Participants rank items on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-480; lower scores indicate higher levels of physical function. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10.	Baseline, Year 2
Primary	Change in PROMIS Bank v2.0 - Mobility Scores from Baseline	15-item self-report assessment of activities of physical mobility. Each item is ranked on a 5-point Likert scale ranging from 0 to 4. The raw score is the sum of responses and ranges from 0-60; lower scores indicate higher levels of physical mobility. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10.	Baseline, Year 2
Primary	Length of Hospital Stay		From admission up to discharge (Up to Year 2)
Primary	Change in Blood Levels during Intraoperative Period	The intraoperative period begins when the patient is transferred to the operating room table and ends when the patient is transferred to the post-anesthesia recovery room.	Beginning of Intraoperative Period (Day 0), End of Intraoperative Period (Day 0) (typically between 2-7 hours).
Primary	Change in Blood Levels during Perioperative Period	The perioperative period comprises the preoperative, intraoperative, and postoperative periods. It begins with the decision that surgical intervention is necessary and ends with the complete recovery from surgery.	Beginning of Preoperative Period (Day 0), End of Postoperative Period (Up to Year 2)