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

NCT02628210 | Completed

• 1 other identifier: RTI-2014-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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.

Conditions

Spondylosis; Spondylolisthesis; Degenerative Disc Disease

Outcome Measures

Primary Outcomes (1)

• Change in the Oswestry Disability Index (ODI)

  Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months

Secondary Outcomes (6)

• Fusion

  6 months, 12 months and 24 months

• Changes in Visual Analog Scale (VAS) pain scores.

  Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months

• Changes in SF-36 scores.

  Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months

• Changes in Lumbar Intervertebral Disc (LID) scores.

  Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months

• Changes in medication use

  Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months

Study Arms (1)

map3® Cellular Allogeneic Bone Graft

OTHER

Patients will receive map3® Cellular Allogeneic Bone Graft

Other: map3® Cellular Allogeneic Bone Graft

Interventions

map3® Cellular Allogeneic Bone Graft OTHER

Patients will receive map3® Cellular Allogeneic Bone Graft

map3® Cellular Allogeneic Bone Graft

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RTI Surgical: lead

Study Sites (3)

Spine Surgery of Buffalo Niagara, LLC

Niagara Falls, New York, 14304, United States

Location

AXIS Neurosurgery and Spine of WNY, PLLC

Williamsville, New York, 14221, United States

Location

Carl & Edyth Lindner Center for Research The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Spondylosis; Spondylolisthesis; Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis

Study Officials

• Jaideep Chundri, MD

  Carl & Edyth Lindner Center for Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2015
• First Posted: December 11, 2015
• Study Start: February 1, 2016
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: May 24, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)