Clinical trial NCT02628210: 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
Overall status: COMPLETED
Phase: NA
Conditions: Spondylosis
Spondylolisthesis
Degenerative Disc Disease
Lead sponsor: RTI Surgical
Sponsor class: INDUSTRY
First posted: 2015-12-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in the Oswestry Disability Index (ODI)
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Secondary outcomes:
measure: Fusion
timeFrame: 6 months, 12 months and 24 months
measure: Changes in Visual Analog Scale (VAS) pain scores.
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
measure: Changes in SF-36 scores.
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
measure: Changes in Lumbar Intervertebral Disc (LID) scores.
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
measure: Changes in medication use
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
measure: Time to return to work
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Other outcomes:
Locations:
city: Niagara Falls
country: United States
facility: Spine Surgery of Buffalo Niagara, LLC
state: New York
city: Williamsville
country: United States
facility: AXIS Neurosurgery and Spine of WNY, PLLC
state: New York
city: Cincinnati
country: United States
facility: Carl & Edyth Lindner Center for Research The Christ Hospital
state: Ohio
Study officials:
affiliation: Carl & Edyth Lindner Center for Research
name: Jaideep Chundri, MD
role: PRINCIPAL_INVESTIGATOR
References: