Study Stopped
Parent sponsor company (Baxter Healthcare) company cut funding
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
1 other identifier
observational
329
3 countries
14
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2009
Longer than P75 for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 8, 2009
CompletedFirst Posted
Study publicly available on registry
September 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedApril 5, 2017
April 1, 2017
3.3 years
September 8, 2009
April 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evidence of successful radiographic fusion
6 months, 12 months & 24 months
Secondary Outcomes (2)
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
Study Arms (1)
Spinal Fusion
Patients who undergo a planned spinal fusion procedure requiring approved bone grafting materials (e.g., bone grft substitutes, allograft or autograft).
Interventions
spine fusion surgery utilizing any commercially available bone graft substitute(s), autograft or allograft
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Baxter Healthcare Corporationlead
- Apatech, Inc.collaborator
Study Sites (14)
UCSF
San Francisco, California, 94143, United States
St. Joseph's Hospital - Resurgeons Orthopedics
Atlanta, Georgia, 30342, United States
Carrollton Orthopedics
Carrollton, Georgia, 30117, United States
Bluegrass Orthopedics & Hand Care Research
Lexington, Kentucky, 40509, United States
Arthritis & Joint Center - U. Mass. Memorial
Worcester, Massachusetts, 01605, United States
PRESSD
Southfield, Michigan, 48072, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322, United States
Montana Neuroscience Institute Foundation
Missoula, Montana, 59802, United States
Physicians Research Options Spine Center
Las Vegas, Nevada, 89144, United States
Syracuse Orthopedic Specialists
Syracuse, New York, 13215, United States
Neurosurgical Associates
Nashville, Tennessee, 37203, United States
Brain & Spine of Texas
Plano, Texas, 75093, United States
Buda Health Center
Budapest, Hungary
Isala Klinieken
Groot Wezenland, Zwolle, 8011 JW, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Huub Kreuwel, Ph.D
Director of Medical Affairs
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2009
First Posted
September 10, 2009
Study Start
September 1, 2009
Primary Completion
January 1, 2013
Study Completion
November 1, 2013
Last Updated
April 5, 2017
Record last verified: 2017-04