Bone Graft Materials Observational Registry

Terminated

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

• Registration Number: NCT00974623
• Lead Sponsor: Baxter Healthcare Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-08
• Study First Submitted QC: 2009-09-09
• Study First Posted: 2009-09-10
• Primary Completion: 2013-01
• Study Completion: 2013-11
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-04
• Last Update Posted: 2017-04-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 329

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Spinal Fusion	Bone graft substitute, autograft or allograft	Patients who undergo a planned spinal fusion procedure requiring approved bone grafting materials (e.g., bone grft substitutes, allograft or autograft).

Primary Outcome Measures

Name	Time	Method
Evidence of successful radiographic fusion	6 months, 12 months & 24 months

Secondary Outcome Measures

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

Trial Locations

Locations (14)

Arthritis & Joint Center - U. Mass. Memorial; 🇺🇸 Worcester, Massachusetts, United States

PRESSD; 🇺🇸 Southfield, Michigan, United States

Montana Neuroscience Institute Foundation; 🇺🇸 Missoula, Montana, United States

St. Joseph's Hospital - Resurgeons Orthopedics; 🇺🇸 Atlanta, Georgia, United States

Bluegrass Orthopedics & Hand Care Research; 🇺🇸 Lexington, Kentucky, United States

Carrollton Orthopedics; 🇺🇸 Carrollton, Georgia, United States

Henry Ford West Bloomfield Hospital; 🇺🇸 West Bloomfield, Michigan, United States

Syracuse Orthopedic Specialists; 🇺🇸 Syracuse, New York, United States

Brain & Spine of Texas; 🇺🇸 Plano, Texas, United States

Buda Health Center; 🇭🇺 Budapest, Hungary

UCSF; 🇺🇸 San Francisco, California, United States

Physicians Research Options Spine Center; 🇺🇸 Las Vegas, Nevada, United States

Neurosurgical Associates; 🇺🇸 Nashville, Tennessee, United States

Isala Klinieken; 🇳🇱 Groot Wezenland, Zwolle, Netherlands