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

May 21, 2021 updated by: RTI Surgical

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.

Study Overview

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

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • Niagara Falls, New York, United States, 14304
        • Spine Surgery of Buffalo Niagara, LLC
      • Williamsville, New York, United States, 14221
        • AXIS Neurosurgery and Spine of WNY, PLLC
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Carl & Edyth Lindner Center for Research The Christ Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: map3® Cellular Allogeneic Bone Graft
Patients will receive map3® Cellular Allogeneic Bone Graft
Patients will receive map3® Cellular Allogeneic Bone Graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in the Oswestry Disability Index (ODI)
Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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
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
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
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
Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Jaideep Chundri, MD, Carl & Edyth Lindner Center for Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

June 1, 2020

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

December 9, 2015

First Submitted That Met QC Criteria

December 9, 2015

First Posted (Estimate)

December 11, 2015

Study Record Updates

Last Update Posted (Actual)

May 24, 2021

Last Update Submitted That Met QC Criteria

May 21, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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