BMAC & Allograft vs BMP-2

Prospective, Blinded, Non-randomized Study of Thoracolumbar Spinal Fusion Graft Efficacy: Bone Marrow Aspirate Concentrate and Allograft Versus Recombinant Bone Morphogenetic Protein-2 (BMP)

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.

Study Overview

• Status: Completed
• Conditions: Spinal Fusion
• Intervention / Treatment: Device: Bone Marrow Aspirate Concentrate (BMAC) + Allograft; Device: Recombinant Human Bone Morphogenetic Protein-2 (BMP); Procedure: Autograft

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.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bone Marrow Aspirate Concentrate (BMAC) + Allograft; A total of 60, 120, or 180 mL of BMA to be aspirated. BMA is then placed into the Harvest SmartPrep® Bone Marrow Concentrate (BMAC) system and concentrated to a final volume of 10, 20, or 30 mL. The BMAC will then be combined with packed allograft cancellous bone chips using the Harvest Graft Delivery Pack. The allograft bone will be obtained routinely from the bone bank in the operating suite. If using Harvest Graft Delivery Kit, the BMAC dosing estimate is as follows (BMAC to graft ratio will be 1:1): 1-level fusion: 10 cc of BMAC from 60 cc of BMA (roughly 10 cc of graft); 2-level fusion: 20 cc of BMAC from 120 cc of BMA; 3-level fusion: 20 cc of BMAC from 120 cc of BMA; 4-level fusion: 180 cc kit; 5-level fusion: 240 cc kit If not using Harvest Graft Delivery Kit: Volume of BMAC will be slightly increased (some BMAC will not get directly into hydrating the graft as the BMAC would get lost in the hydration process and left in mixing bowls).	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.; Other Names: Harvest BMAC System
Active Comparator: Recombinant Human Bone Morphogenetic Protein-2 (BMP); 12 mL BMP will be applied at the surgical site of the interbody fusion using a collagen sponge following manufacturer's directions. The BMP kit use per level is as follows: 1 Level Fusion: Extra small kit (1.4 cc); 2 Level Fusion: Small Kit (2.8cc); 3 Level Fusion: (4.2 cc); 4 Level Fusion: Medium Kit (5.6cc); 5 Level Fusion: (7.0 cc)	Device: 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.; Other Names: INFUSE rhBMP-2
Active Comparator: Autograft; As per standard of care, the control group will receive 15cc - 45 cc of allograft with autograft and bone marrow aspirate at each level. The iliac crest is the common donor site for autograft. Using the standard technique for anterior lateral fusion, the bone graft will be laid onto the desired site of fusion.	Procedure: Autograft; Autograft with bone marrow aspirate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Rating Scale (NRS) - Back Pain Score at Pre-Op Visit	Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain.	Pre-Operation Visit (Day 0)
NRS - Back Pain Score at Week 6 Follow-Up	Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain.	Week 6 Post-Operation
NRS - Back Pain Score at Month 3 Follow-Up	Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain.	Month 3 Post-Operation
NRS - Back Pain Score at Month 6 Follow-Up	Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain.	Month 6 Post-Operation
NRS - Back Pain Score at Month 12 Follow-Up	Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain.	Month 12 Post-Operation
NRS - Back Pain Score at Month 24 Follow-Up	Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain.	Month 24 Post-Operation
Short Form 12 (SF-12) - Physical Component Summary (PCS) Score at Pre-Op Visit	The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life.	Pre-Operation Visit (Day 0)
SF-12 - PCS Score at Week 6 Follow-Up	The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life.	Week 6 Post-Operation
SF-12 - PCS Score at Month 3 Follow-Up	The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life.	Month 3 Post-Operation
SF-12 - PCS Score at Month 6 Follow-Up	The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life.	Month 6 Post-Operation
SF-12 - PCS Score at Month 12 Follow-Up	The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life.	Month 12 Post-Operation
SF-12 - PCS Score at Month 24 Follow-Up	The SF-12 PCS is a physical component summary score from the Short Form 12 (SF-12) health survey. The PCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater physical quality of life.	Month 24 Post-Operation
SF-12 - Mental Component Summary (MCS) Score at Pre-Op Visit	The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life.	Pre-Operation Visit (Day 0)
SF-12 - MCS Score at Week 6 Follow-Up	The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life.	Week 6 Post-Operation
Euro-Qol 5-Dimension (EQ-5D) Score at Pre-Op Visit	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.	Pre-Operation Visit (Day 0)
EQ-5D Score at Week 6 Follow-Up	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.	Week 6 Post-Operation
EQ-5D Score at Month 3 Follow-Up	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.	Month 3 Post-Operation
EQ-5D Score at Month 6 Follow-Up	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.	Month 6 Post-Operation
EQ-5D Score at Month 12 Follow-Up	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.	Month 12 Post-Operation
EQ-5D Score at Month 24 Follow-Up	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.	Month 24 Post-Operation
Pain Catastrophizing Scale (PCS) Score at Pre-Op Visit	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.	Pre-Operation Visit (Day 0)
PCS Score at Week 6 Follow-Up	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.	Week 6 Post-Operation
PCS Score at Month 3 Follow-Up	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.	Month 3 Post-Operation
PCS Score at Month 6 Follow-Up	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.	Month 6 Post-Operation
PCS Score at Month 12 Follow-Up	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.	Month 12 Post-Operation
PCS Score at Month 24 Follow-Up	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.	Month 24 Post-Operation
Length of Operation		Intraoperative Period (Day 0) (typically between 2-7 hours)
Length of Hospital Stay		From admission up to discharge (Up to Year 2 Post-Operation)
Blood Loss During Procedure		Intraoperative Period (Day 0) (typically between 2-7 hours)
Number of Participants With Successful Fusion Status at Month 12 Post-Procedure	Fusion status assessed via CT scan by an independent radiologist.	Month 12 Post-Operation
Oswestry Disability Index (ODI) Score at Pre-Op Visit	The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled.	Pre-Operation Visit (Day 0)
ODI Score at Week 6 Follow-Up	The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled.	Week 6 Post-Operation
ODI Score at Month 3 Follow-Up	The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled.	Month 3 Post-Operation
ODI Score at Month 6 Follow-Up	The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled.	Month 6 Post-Operation
ODI Score at Month 12 Follow-Up	The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled.	Month 12 Post-Operation
ODI Score at Month 24 Follow-Up	The ODI is a questionnaire used to assess the functional disability caused by low back pain. It consists of 10 questions, each rated on a scale of 0 (none) to 5 (extreme). The scores from the 10 questions are added up to obtain the raw score; the raw score is divided by the maximum possible score (50) and multiplied by 100 to obtain a percentage score, interpreted as follows: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippling disability, and 81-100%: Bedridden or completely disabled.	Month 24 Post-Operation
SF-12 - MCS Score at Month 3 Follow-Up	The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life.	Month 3 Follow-Up Post-Operation
SF-12 - MCS Score at Month 6 Follow-Up	The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life.	Month 6 Post-Operation
Patient Reported Outcome Measure Information System (PROMIS) Item Bank v1.1 - Pain Interference Score at Pre-Op Visit	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 ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain.	Pre-Operation Visit (Day 0)
PROMIS Item Bank v1.1 - Pain Interference Score at Week 6 Follow-Up	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 ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain.	Week 6 Post-Operation
PROMIS Item Bank v1.1 - Pain Interference Score at Month 3 Follow-Up	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 ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain.	Month 3 Post-Operation
PROMIS Item Bank v1.1 - Pain Interference Score at Month 6 Follow-Up	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 ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain.	Month 6 Post-Operation
PROMIS Item Bank v1.1 - Pain Interference Score at Month 12 Follow-Up	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 ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain.	Month 12 Post-Operation
PROMIS Item Bank v1.1 - Pain Interference Score at Month 24 Follow-Up	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 ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater interference from pain.	Month 24 Post-Operation
PROMIS Scale v1.0 - Pain Intensity 3a Score at Pre-Op Visit	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 ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain.	Pre-Operation Visit (Day 0)
PROMIS Scale v1.0 - Pain Intensity 3a Score at Week 6 Follow-Up	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 ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain.	Week 6 Post-Operation
PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 3 Follow-Up	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 ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain.	Month 3 Post-Operation
PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 6 Follow-Up	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 ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain.	Month 6 Post-Operation
PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 12 Follow-Up	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 ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain.	Month 12 Post-Operation
PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 24 Follow-Up	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 ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate higher intensity of pain.	Month 24 Post-Operation
PROMIS Bank v1.2 - Physical Function Score at Pre-Op Visit	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 ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function.	Pre-Operation Visit (Day 0)
PROMIS Bank v1.2 - Physical Function Score at Week 6 Follow-Up	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 ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function.	Week 6 Post-Operation
PROMIS Bank v1.2 - Physical Function Score at Month 3 Follow-Up	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 ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function.	Month 3 Post-Operation
PROMIS Bank v1.2 - Physical Function Score at Month 6 Follow-Up	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 ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function.	Month 6 Post-Operation
PROMIS Bank v1.2 - Physical Function Score at Month 12 Follow-Up	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 ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function.	Month 12 Post-Operation
PROMIS Bank v1.2 - Physical Function Score at Month 24 Follow-Up	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 ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate greater physical function.	Month 24 Post-Operation
PROMIS Bank v2.0 - Mobility Score at Pre-Op Visit	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 ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility.	Pre-Operation Visit (Day 0)
PROMIS Bank v2.0 - Mobility Score at Week 6 Follow-Up	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 ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility.	Week 6 Post-Operation
PROMIS Bank v2.0 - Mobility Score at Month 3 Follow-Up	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 ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility.	Month 3 Post-Operation
PROMIS Bank v2.0 - Mobility Score at Month 6 Follow-Up	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 ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility.	Month 6 Post-Operation
PROMIS Bank v2.0 - Mobility Score at Month 12 Follow-Up	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 ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility.	Month 12 Post-Operation
PROMIS Bank v2.0 - Mobility Score at Month 24 Follow-Up	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 ranging from 0-100, with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate greater physical mobility.	Month 24 Post-Operation
Number of Participants Using Non-Prescription, Over-the-Counter (OTC) Drugs at Pre-Op Visit	Number of participants taking OTC drugs for pain relief.	Pre-Operation Visit (Day 0)
Number of Participants Using Non-Prescription, OTC Drugs at Week 6 Follow-Up	Number of participants taking OTC drugs for pain relief.	Week 6 Post-Operation
Number of Participants Using Non-Prescription, OTC Drugs at Month 3 Follow-Up	Number of participants taking OTC drugs for pain relief.	Month 3 Post-Operation
Number of Participants Using Non-Prescription, OTC Drugs at Month 6 Follow-Up	Number of participants taking OTC drugs for pain relief.	Month 6 Post-Operation
Number of Participants Using Non-Prescription, OTC Drugs at Month 12 Follow-Up	Number of participants taking OTC drugs for pain relief.	Month 12 Post-Operation
Number of Participants Using Non-Prescription, OTC Drugs at Month 24 Follow-Up	Number of participants taking OTC drugs for pain relief.	Month 24 Post-Operation
Number of Participants With Surgical Complications During Operation		Intraoperative Period (Day 0) (typically between 2-7 hours)
Number of Participants With Surgical Complications at Week 6 Follow-Up		Week 6 Post-Operation
Number of Participants With Surgical Complications at Month 3 Follow-Up		Month 3 Post-Operation
Number of Participants With Surgical Complications at Month 6 Follow-Up		Month 6 Post-Operation
Number of Participants With Surgical Complications at Month 12 Follow-Up		Month 12 Post-Operation
Number of Participants With Surgical Complications at Month 24 Follow-Up		Month 24 Post-Operation
SF-12 - MCS Score at Month 12 Follow-Up	The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life.	Month 12 Post-Operation
SF-12 - MCS Score at Month 24 Follow-Up	The SF-12 MCS is a mental component summary score from the Short Form 12 (SF-12) health survey. The MCS portion of the survey comprises 6 items; the item scores are standardized to a final t-score. The final score ranges from 0-100 with a mean of 50. Higher scores indicate greater mental quality of life.	Month 12 Post-Operation

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Peter Passias, NYU Langone Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2018
• Primary Completion (Actual): June 3, 2024
• Study Completion (Actual): June 3, 2024

Study Registration Dates

• First Submitted: October 3, 2016
• First Submitted That Met QC Criteria: October 3, 2016
• First Posted (Estimated): October 5, 2016

Study Record Updates

• Last Update Posted (Actual): July 8, 2025
• Last Update Submitted That Met QC Criteria: June 18, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 16-01160

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No