Bone Graft Materials Observational Registry (APPROACH-001)

A Prospective Patient Registry for Bone Graft Substitutes in Spinal Fusion: Patient Outcomes and Use in Clinical Practice

A multi-center, prospective, observational patient registry to collect information on the clinical outcomes and "real world" use of approved and commercially available bone graft substitutes, autograft and allograft.

Study Overview

• Status: Terminated
• Conditions: Degenerative Disc Disease; Spinal Stenosis; Herniated Disc; Cervical Myelopathy; Spinal Cord Neoplasms; Spinal Deformity; Failed Back Surgery Syndrome; Spondylolithesis
• Intervention / Treatment: Device: Bone graft substitute, autograft or allograft

• Study Type: Observational
• Enrollment (Actual): 329

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary
    • Buda Health Center
• Netherlands
  • Zwolle
    • Groot Wezenland, Zwolle, Netherlands, 8011 JW
      • Isala Klinieken
• United States
  • California
    • San Francisco, California, United States, 94143
      • UCSF
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • St. Joseph's Hospital - Resurgeons Orthopedics
    • Carrollton, Georgia, United States, 30117
      • Carrollton Orthopedics
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Bluegrass Orthopedics & Hand Care Research
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • Arthritis & Joint Center - U. Mass. Memorial
  • Michigan
    • Southfield, Michigan, United States, 48072
      • PRESSD
    • West Bloomfield, Michigan, United States, 48322
      • Henry Ford West Bloomfield Hospital
  • Montana
    • Missoula, Montana, United States, 59802
      • Montana Neuroscience Institute Foundation
  • Nevada
    • Las Vegas, Nevada, United States, 89144
      • Physicians Research Options Spine Center
  • New York
    • Syracuse, New York, United States, 13215
      • Syracuse Orthopedic Specialists
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Neurosurgical Associates
  • Texas
    • Plano, Texas, United States, 75093
      • Brain & Spine of Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients enrolled in this study will be identified from the surgeon's medical practice and will include patients who failed conservative care and have been identified as requiring spinal fusion surgery.

Description

Inclusion Criteria:

• The patient has failed conservative treatment and is a candidate for spinal fusion surgery.
• The patient is ≥18 years old and of legal age of consent.
• The patient is, in the investigator's opinion, psychosocially, mentally, and physically able to fully comply with this protocol, including the post-operative regimen, required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent.
• The patient is skeletally mature (epiphyses closed).
• The patient has signed the IRB approved informed consent.
• The patient is willing and able to participate in post-operative clinical and radiographic follow up evaluations for 2 years.

Exclusion Criteria:

• Patient has systemic infection or infection at the surgical site.
• Patient has a medical condition that would interfere with post-operative assessments and care (i.e., neuromuscular disease, psychiatric disease, paraplegia, quadriplegia, etc.).
• Patient is in poor general health or any concurrent disease process that would place the patient in excessive risk to surgery (i.e., significant circulatory or pulmonary problems, or cardiac disease).
• Patient has a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or with the patient's ability to complete the protocol required follow-up.
• The patient is pregnant/breastfeeding at the time of enrollment, or plans to become pregnant during the course of the study.
• Patient is participating in another investigational study, which could confound results.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Spinal Fusion; Patients who undergo a planned spinal fusion procedure requiring approved bone grafting materials (e.g., bone grft substitutes, allograft or autograft).	Device: Bone graft substitute, autograft or allograft; spine fusion surgery utilizing any commercially available bone graft substitute(s), autograft or allograft; Other Names: Autograft; Allograft/DBM; Ceramics; Synthetics; BMP; Messenchymal stem cell therapies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evidence of successful radiographic fusion	6 months, 12 months & 24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Maintenance or improvement in neurological status, as compared to baseline scores	6 months 12 months & 24 months
Improvement of pain/function in comparison to pre-operative QOL scores	6 months, 12 months & 24 months

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation
• Collaborators: Apatech, Inc.
• Investigators: Study Director: Huub Kreuwel, Ph.D, Director of Medical Affairs

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (ACTUAL): January 1, 2013
• Study Completion (ACTUAL): November 1, 2013

Study Registration Dates

• First Submitted: September 8, 2009
• First Submitted That Met QC Criteria: September 9, 2009
• First Posted (ESTIMATE): September 10, 2009

Study Record Updates

• Last Update Posted (ACTUAL): April 5, 2017
• Last Update Submitted That Met QC Criteria: April 4, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Allograft; Autograft; Spine fusion; Bone growth substitute
• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Postoperative Complications; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Central Nervous System Neoplasms; Nervous System Neoplasms; Spinal Diseases; Bone Diseases; Hernia; Back Pain; Intervertebral Disc Displacement; Intervertebral Disc Degeneration; Spinal Cord Diseases; Spinal Stenosis; Spinal Cord Neoplasms; Failed Back Surgery Syndrome
• Other Study ID Numbers: APPROACH-001