BMAC & Allograft vs BMP-2
- Conditions
- Spinal Fusion
- Interventions
- Device: Recombinant Human Bone Morphogenetic Protein-2 (BMP)Device: Bone Marrow Aspirate Concentrate (BMAC) + AllograftProcedure: Autograft
- Registration Number
- NCT02924571
- Lead Sponsor
- NYU Langone Health
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Recombinant Human Bone Morphogenetic Protein-2 (BMP) 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) Bone Marrow Aspirate Concentrate (BMAC) + Allograft 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 SmartPrepĀ® 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). Autograft 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.
- Primary Outcome Measures
Name Time Method Number of Participants with Successful Fusion Status at Month 12 Post-Procedure Month 12 Post-Operation Fusion status assessed via CT scan by an independent radiologist.
Oswestry Disability Index (ODI) Score at Pre-Op Visit Pre-Operation Visit (Day 0) 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.
ODI Score at Week 6 Follow-Up Week 6 Post-Operation 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.
ODI Score at Month 3 Follow-Up Month 3 Post-Operation 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.
ODI Score at Month 6 Follow-Up Month 6 Post-Operation 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.
ODI Score at Month 12 Follow-Up Month 12 Post-Operation 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.
ODI Score at Month 24 Follow-Up Month 24 Post-Operation 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.
Numeric Rating Scale (NRS) - Back Pain Score at Pre-Op Visit Pre-Operation Visit (Day 0) Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain.
NRS - Back Pain Score at Week 6 Follow-Up Week 6 Post-Operation Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain.
NRS - Back Pain Score at Month 3 Follow-Up Month 3 Post-Operation Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain.
NRS - Back Pain Score at Month 6 Follow-Up Month 6 Post-Operation Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain.
NRS - Back Pain Score at Month 12 Follow-Up Month 12 Post-Operation Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain.
NRS - Back Pain Score at Month 24 Follow-Up Month 24 Post-Operation Participants evaluate leg and back pain using a VAS ranging from 0 cm to 10 cm. Lower scores indicate lower levels of pain.
Short Form 12 (SF-12) - Physical Component Summary (PCS) Score at Pre-Op Visit Pre-Operation Visit (Day 0) 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.
SF-12 - PCS Score at Week 6 Follow-Up Week 6 Post-Operation 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.
SF-12 - PCS Score at Month 3 Follow-Up Month 3 Post-Operation 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.
SF-12 - PCS Score at Month 6 Follow-Up Month 6 Post-Operation 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.
SF-12 - PCS Score at Month 12 Follow-Up Month 12 Post-Operation 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.
SF-12 - PCS Score at Month 24 Follow-Up Month 24 Post-Operation 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.
SF-12 - Mental Component Summary (MCS) Score at Pre-Op Visit Pre-Operation Visit (Day 0) 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.
SF-12 - MCS Score at Week 6 Follow-Up Week 6 Post-Operation 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.
SF-12 - MCS Score at Week 12 Follow-Up Week 12 Post-Operation 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.
SF-12 - MCS Score at Week 24 Follow-Up Week 24 Post-Operation 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.
Euro-Qol 5-Dimension (EQ-5D) Score at Pre-Op Visit Pre-Operation Visit (Day 0) 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.
EQ-5D Score at Week 6 Follow-Up Week 6 Post-Operation 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.
EQ-5D Score at Month 3 Follow-Up Month 3 Post-Operation 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.
EQ-5D Score at Month 6 Follow-Up Month 6 Post-Operation 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.
EQ-5D Score at Month 12 Follow-Up Month 12 Post-Operation 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.
EQ-5D Score at Month 24 Follow-Up Month 24 Post-Operation 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.
Pain Catastrophizing Scale (PCS) Score at Pre-Op Visit Pre-Operation Visit (Day 0) 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.
PCS Score at Week 6 Follow-Up Week 6 Post-Operation 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.
PCS Score at Month 3 Follow-Up Month 3 Post-Operation 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.
PCS Score at Month 6 Follow-Up Month 6 Post-Operation 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.
PCS Score at Month 12 Follow-Up Month 12 Post-Operation 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.
PCS Score at Month 24 Follow-Up Month 24 Post-Operation 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.
Patient Reported Outcome Measure Information System (PROMIS) Item Bank v1.1 - Pain Interference Score at Pre-Op Visit Pre-Operation Visit (Day 0) 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.
PROMIS Item Bank v1.1 - Pain Interference Score at Week 6 Follow-Up Week 6 Post-Operation 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.
PROMIS Item Bank v1.1 - Pain Interference Score at Month 3 Follow-Up Month 3 Post-Operation 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.
PROMIS Item Bank v1.1 - Pain Interference Score at Month 6 Follow-Up Month 6 Post-Operation 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.
PROMIS Item Bank v1.1 - Pain Interference Score at Month 12 Follow-Up Month 12 Post-Operation 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.
PROMIS Item Bank v1.1 - Pain Interference Score at Month 24 Follow-Up Month 24 Post-Operation 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.
PROMIS Scale v1.0 - Pain Intensity 3a Score at Pre-Op Visit Pre-Operation Visit (Day 0) 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.
PROMIS Scale v1.0 - Pain Intensity 3a Score at Week 6 Follow-Up Week 6 Post-Operation 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.
PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 3 Follow-Up Month 3 Post-Operation 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.
PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 6 Follow-Up Month 6 Post-Operation 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.
PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 12 Follow-Up Month 12 Post-Operation 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.
PROMIS Scale v1.0 - Pain Intensity 3a Score at Month 24 Follow-Up Month 24 Post-Operation 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.
PROMIS Bank v1.2 - Physical Function Score at Pre-Op Visit Pre-Operation Visit (Day 0) 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.
PROMIS Bank v1.2 - Physical Function Score at Week 6 Follow-Up Week 6 Post-Operation 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.
PROMIS Bank v1.2 - Physical Function Score at Month 3 Follow-Up Month 3 Post-Operation 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.
PROMIS Bank v1.2 - Physical Function Score at Month 6 Follow-Up Month 6 Post-Operation 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.
PROMIS Bank v1.2 - Physical Function Score at Month 12 Follow-Up Month 12 Post-Operation 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.
PROMIS Bank v1.2 - Physical Function Score at Month 24 Follow-Up Month 24 Post-Operation 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.
PROMIS Bank v2.0 - Mobility Score at Pre-Op Visit Pre-Operation Visit (Day 0) 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.
PROMIS Bank v2.0 - Mobility Score at Week 6 Follow-Up Week 6 Post-Operation 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.
PROMIS Bank v2.0 - Mobility Score at Month 3 Follow-Up Month 3 Post-Operation 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.
PROMIS Bank v2.0 - Mobility Score at Month 6 Follow-Up Month 6 Post-Operation 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.
PROMIS Bank v2.0 - Mobility Score at Month 12 Follow-Up Month 12 Post-Operation 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.
PROMIS Bank v2.0 - Mobility Score at Month 24 Follow-Up Month 24 Post-Operation 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.
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 using Non-Prescription, Over-the-Counter (OTC) Drugs at Pre-Op Visit Pre-Operation Visit (Day 0) Number of participants taking OTC drugs for pain relief.
Number of Participants using Non-Prescription, OTC Drugs at Week 6 Follow-Up Week 6 Post-Operation Number of participants taking OTC drugs for pain relief.
Number of Participants using Non-Prescription, OTC Drugs at Month 3 Follow-Up Month 3 Post-Operation Number of participants taking OTC drugs for pain relief.
Number of Participants using Non-Prescription, OTC Drugs at Month 6 Follow-Up Month 6 Post-Operation Number of participants taking OTC drugs for pain relief.
Number of Participants using Non-Prescription, OTC Drugs at Month 12 Follow-Up Month 12 Post-Operation Number of participants taking OTC drugs for pain relief.
Number of Participants using Non-Prescription, OTC Drugs at Month 24 Follow-Up Month 24 Post-Operation Number of participants taking OTC drugs for pain relief.
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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
New York University School of Medicine
šŗšøNew York, New York, United States