SpondylosisNCT02628210
Interbody Spacers With map3® Cellular Allogeneic Bone Graft in Anterior or Lateral Lumbar Interbody Fusion
A study testing map3® Cellular Allogeneic Bone Graft in people with Spondylosis and Spondylolisthesis, run by RTI Surgical at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spondylosis, Spondylolisthesis, Degenerative Disc Disease
- What is being tested?
- map3® Cellular Allogeneic Bone Graft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2016to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Carl & Edyth Lindner Center for Research The Christ Hospital
Cincinnati, Ohio, 45219
Spine Surgery of Buffalo Niagara, LLC
Niagara Falls, New York, 14304
AXIS Neurosurgery and Spine of WNY, PLLC
Williamsville, New York, 14221
About this study
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
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.
Read the 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.
- Conditions
- Spondylosis, Spondylolisthesis, Degenerative Disc Disease
- Being tested
- map3® Cellular Allogeneic Bone Graft
- Medical subject headings
- Spondylosis, Spondylolisthesis, Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
map3® Cellular Allogeneic Bone GraftOther
Patients will receive map3® Cellular Allogeneic Bone Graft
| Study group | Role | What they receive |
|---|---|---|
| map3® Cellular Allogeneic Bone Graft | Other | Patients will receive map3® Cellular Allogeneic Bone Graft Receives: Other: map3® Cellular Allogeneic Bone Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Oswestry Disability Index (ODI)
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Secondary outcomes (6)
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.
Measured: 6 months, 12 months and 24 months
Changes in Visual Analog Scale (VAS) pain scores.
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Changes in SF-36 scores.
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Changes in Lumbar Intervertebral Disc (LID) scores.
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Changes in medication use
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Time to return to work
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startFeb 2016
- Primary completionJun 2020
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondylosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaideep Chundri, MD, Principal investigator, Carl & Edyth Lindner Center for Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02628210
- Sponsor's protocol ID
- RTI-2014-02
- Status last verified
- May 2021
- First submitted
- 9 Dec 2015
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02628210
- Acronym / sponsor ID
- RTI-2014-02
- Conditions
- Spondylosis, Spondylolisthesis, Degenerative Disc Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- RTI SurgicalIndustry (pharma, biotech, devices)
- Study start
- Feb 2016 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 11 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| map3® Cellular Allogeneic Bone Graft | Other | Other: map3® Cellular Allogeneic Bone GraftPatients will receive map3® Cellular Allogeneic Bone Graft |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (22 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| map3® Cellular Allogeneic Bone GraftPatients will receive map3® Cellular Allogeneic Bone Graft | Other | map3® Cellular Allogeneic Bone Graft |
Primary outcome
Change in the Oswestry Disability Index (ODI)
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
6 secondary outcomes
Fusion
Time frame: 6 months, 12 months and 24 months
Changes in Visual Analog Scale (VAS) pain scores.
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Changes in SF-36 scores.
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Changes in Lumbar Intervertebral Disc (LID) scores.
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Changes in medication use
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Time to return to work
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
- Individual participant dataSharing planned: No
Related trials for Spondylosis
Not yet recruiting
Comparative Effectiveness of Two Different Approaches to Radiofrequency Ablation of Lumbar Medial Branch Nerves
Lumbar Spondylosis
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Active, not recruiting
SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion
Lumbar Spondylolisthesis, Grade 1 Spondylolisthesis
Enrolling by invitation
Assessing Microbiome in Primary Anterior Cervical Fusion Patients
Cervical Stenosis, Myelopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaideep Chundri, MD principal investigator
Carl & Edyth Lindner Center for Research
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing map3® Cellular Allogeneic Bone Graft in people with Spondylosis and Spondylolisthesis, run by RTI Surgical at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Oswestry Disability Index (ODI) (time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2021.