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Interbody Spacers With map3® Cellular Allogeneic Bone Graft in Anterior or Lateral Lumbar Interbody Fusion

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ClinicalTrials.gov Identifier: NCT02628210
Recruitment Status : Active, not recruiting
First Posted : December 11, 2015
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
RTI Surgical

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.

Condition or disease Intervention/treatment Phase
Spondylosis Spondylolisthesis Degenerative Disc Disease Other: map3® Cellular Allogeneic Bone Graft Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2015
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Arm Intervention/treatment
map3® Cellular Allogeneic Bone Graft
Patients will receive map3® Cellular Allogeneic Bone Graft
Other: map3® Cellular Allogeneic Bone Graft
Patients will receive map3® Cellular Allogeneic Bone Graft




Primary Outcome Measures :
  1. Change in the Oswestry Disability Index (ODI) [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months ]

Secondary Outcome Measures :
  1. Fusion [ Time Frame: 6 months, 12 months and 24 months ]

    Fusion at the operated level, based on

    • Bridging trabecular bone.
    • Less than 3 mm of translational motion.
    • Less than 5 degrees of angular motion.

  2. Changes in Visual Analog Scale (VAS) pain scores. [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months ]
  3. Changes in SF-36 scores. [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months ]
  4. Changes in Lumbar Intervertebral Disc (LID) scores. [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months ]
  5. Changes in medication use [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months ]
  6. Time to return to work [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02628210


Locations
United States, New York
Spine Surgery of Buffalo Niagara, LLC
Niagara Falls, New York, United States, 14304
AXIS Neurosurgery and Spine of WNY, PLLC
Williamsville, New York, United States, 14221
United States, Ohio
Carl & Edyth Lindner Center for Research The Christ Hospital
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
RTI Surgical
Investigators
Principal Investigator: Jaideep Chundri, MD Carl & Edyth Lindner Center for Research

Responsible Party: RTI Surgical
ClinicalTrials.gov Identifier: NCT02628210     History of Changes
Other Study ID Numbers: RTI-2014-02
First Posted: December 11, 2015    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Spondylolisthesis
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis