Interbody Spacers With map3® Cellular Allogeneic Bone Graft in Anterior or Lateral Lumbar Interbody Fusion
Primary Purpose
Spondylosis, Spondylolisthesis, Degenerative Disc Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
map3® Cellular Allogeneic Bone Graft
Sponsored by
![RTI Surgical](https://trials-media.s3.amazonaws.com/orgs/rti-surgical.jpeg)
About this trial
This is an interventional treatment trial for Spondylosis
Eligibility Criteria
Inclusion Criteria:
- is at least 18 - 75 years of age and skeletally mature
- must have symptomatic spondylosis, spondylolisthesis grade I or II, or degenerative disc disease (DDD) at one level from L2-S1 requiring a fusion
- must be a candidate to use an allograft spacer
- must be a candidate for bilateral pedicle screw placement
- must have completed a minimum of six weeks (+/- two to four weeks of bracing) of unsuccessful conservative, non-operative care
- must have discogenic back pain with or without leg pain DDD must be confirmed by MRI or CT scans followed by discography (if necessary)
- must score at least 40 % on the Oswestry Disability Index
- must score 4 or more on a 10 cm Visual Analog Scale for back pain or leg pain
- must be able to comply with the protocol's follow-up schedule
- must understand and sign the informed consent documenT
Exclusion Criteria:
- symptomatic at more than one level
- previous fusion surgery at any lumbar level with or without instrumentation.
- any other bone grafting product other than study product and local autograft bone. e.g. rhBMP2, (recombinant human bone morphogenetic protein 2).
- patients requiring any other interbody fusion device other than an allograft spacer (Bigfoot™, Crossfuse® Advantage). e.g. no PEEK IBF
- more than 50% spondylolisthesis (Myerding grade III or more)
- lumbar scoliosis greater than 11 degrees
- osteoporosis* (T-score of -2.5 or lower), osteomalacia, Paget's disease or --metabolic bone disease.
- spinal tumors
- active arachnoiditis
- fractures of the epiphyseal plate or fractures for which stabilization of the fracture is not possible.
- impaired calcium metabolism
- active infection or surgical site infection
- rheumatoid arthritis or other autoimmune disease that affects bone healing (at the surgeon's discretion)
- chronic steroid use except for chronic inhalers (used steroids for one month within the last 6 months) or any medical condition that requires treatment with drugs known to interfere with bone healing
- use of glucocorticoids > 10 mg/day
- systemic disease such as AIDS, HIV, hepatitis (active), tuberculosis
- morbid obesity defined as body mass index (BMI) >45 or a weight more than 100 lbs. over ideal body weight
- uncontrolled diabetes documented with an Hbg A1C >9 or insulin dependent diabetics
- smokers unless approved by Sponsor, including electronic cigarettes and vaporizers
- within the past two (2) years, psychosocial disorders that would preclude accurate evaluation or has a history of substance abuse any history or active cancer
- pregnancy, or interested in becoming pregnant while participating in the study
- participation in another investigational study within 30 days
Sites / Locations
- Spine Surgery of Buffalo Niagara, LLC
- AXIS Neurosurgery and Spine of WNY, PLLC
- Carl & Edyth Lindner Center for Research The Christ Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
map3® Cellular Allogeneic Bone Graft
Arm Description
Patients will receive map3® Cellular Allogeneic Bone Graft
Outcomes
Primary Outcome Measures
Change in the Oswestry Disability Index (ODI)
Secondary Outcome Measures
Fusion
Fusion at the operated level, based on
Bridging trabecular bone.
Less than 3 mm of translational motion.
Less than 5 degrees of angular motion.
Changes in Visual Analog Scale (VAS) pain scores.
Changes in SF-36 scores.
Changes in Lumbar Intervertebral Disc (LID) scores.
Changes in medication use
Time to return to work
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02628210
Brief Title
Interbody Spacers With map3® Cellular Allogeneic Bone Graft in Anterior or Lateral Lumbar Interbody Fusion
Official Title
A Prospective, Multi-Center, Non-Randomized Study to Assess Clinical Outcomes Using Interbody Spacers With map3® Cellular Allogeneic Bone Graft in Anterior Lumbar Interbody Fusion or Lateral Lumbar Interbody Fusion
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
June 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RTI Surgical
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a single-arm post-market study in patients requiring lumbar fusion using allograft interbody spacer in conjunction with map3® Cellular Allogeneic Bone Graft in patients with degenerative disc disease (DDD). This cohort study will enroll 80 patients total at up to 10 sites. After subjects have signed an informed consent, the baseline visit and examinations will be completed. Patients will be evaluated at 6 weeks, 3 months, 6 months, 12 months, and 24 month visit after surgery.
Detailed Description
Map3 is an allogeneic bone matrix which also contains demineralized cortical cancellous bone and multipotent adult progenitor cells (MAPC). MAPC-based cells are derived from allograft bone marrow, isolated from other cells and cryopreserved. Both the scaffold and cellular constituents are processed from the same donor but are provided in separate containers. Scaffold and cells combined constitute the implant and must be used together. The map3 implant is available in Strips allograft and Chips allograft configurations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondylosis, Spondylolisthesis, Degenerative Disc Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
map3® Cellular Allogeneic Bone Graft
Arm Type
Other
Arm Description
Patients will receive map3® Cellular Allogeneic Bone Graft
Intervention Type
Other
Intervention Name(s)
map3® Cellular Allogeneic Bone Graft
Intervention Description
Patients will receive map3® Cellular Allogeneic Bone Graft
Primary Outcome Measure Information:
Title
Change in the Oswestry Disability Index (ODI)
Time Frame
Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Secondary Outcome Measure Information:
Title
Fusion
Description
Fusion at the operated level, based on
Bridging trabecular bone.
Less than 3 mm of translational motion.
Less than 5 degrees of angular motion.
Time Frame
6 months, 12 months and 24 months
Title
Changes in Visual Analog Scale (VAS) pain scores.
Time Frame
Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Title
Changes in SF-36 scores.
Time Frame
Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Title
Changes in Lumbar Intervertebral Disc (LID) scores.
Time Frame
Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Title
Changes in medication use
Time Frame
Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Title
Time to return to work
Time Frame
Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
is at least 18 - 75 years of age and skeletally mature
must have symptomatic spondylosis, spondylolisthesis grade I or II, or degenerative disc disease (DDD) at one level from L2-S1 requiring a fusion
must be a candidate to use an allograft spacer
must be a candidate for bilateral pedicle screw placement
must have completed a minimum of six weeks (+/- two to four weeks of bracing) of unsuccessful conservative, non-operative care
must have discogenic back pain with or without leg pain DDD must be confirmed by MRI or CT scans followed by discography (if necessary)
must score at least 40 % on the Oswestry Disability Index
must score 4 or more on a 10 cm Visual Analog Scale for back pain or leg pain
must be able to comply with the protocol's follow-up schedule
must understand and sign the informed consent documenT
Exclusion Criteria:
symptomatic at more than one level
previous fusion surgery at any lumbar level with or without instrumentation.
any other bone grafting product other than study product and local autograft bone. e.g. rhBMP2, (recombinant human bone morphogenetic protein 2).
patients requiring any other interbody fusion device other than an allograft spacer (Bigfoot™, Crossfuse® Advantage). e.g. no PEEK IBF
more than 50% spondylolisthesis (Myerding grade III or more)
lumbar scoliosis greater than 11 degrees
osteoporosis* (T-score of -2.5 or lower), osteomalacia, Paget's disease or --metabolic bone disease.
spinal tumors
active arachnoiditis
fractures of the epiphyseal plate or fractures for which stabilization of the fracture is not possible.
impaired calcium metabolism
active infection or surgical site infection
rheumatoid arthritis or other autoimmune disease that affects bone healing (at the surgeon's discretion)
chronic steroid use except for chronic inhalers (used steroids for one month within the last 6 months) or any medical condition that requires treatment with drugs known to interfere with bone healing
use of glucocorticoids > 10 mg/day
systemic disease such as AIDS, HIV, hepatitis (active), tuberculosis
morbid obesity defined as body mass index (BMI) >45 or a weight more than 100 lbs. over ideal body weight
uncontrolled diabetes documented with an Hbg A1C >9 or insulin dependent diabetics
smokers unless approved by Sponsor, including electronic cigarettes and vaporizers
within the past two (2) years, psychosocial disorders that would preclude accurate evaluation or has a history of substance abuse any history or active cancer
pregnancy, or interested in becoming pregnant while participating in the study
participation in another investigational study within 30 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaideep Chundri, MD
Organizational Affiliation
Carl & Edyth Lindner Center for Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spine Surgery of Buffalo Niagara, LLC
City
Niagara Falls
State/Province
New York
ZIP/Postal Code
14304
Country
United States
Facility Name
AXIS Neurosurgery and Spine of WNY, PLLC
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Carl & Edyth Lindner Center for Research The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Interbody Spacers With map3® Cellular Allogeneic Bone Graft in Anterior or Lateral Lumbar Interbody Fusion
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