Bone Graft Materials Observational Registry

Degenerative Disc Disease Clinical Trial

— APPROACH-001  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00974623
• Other study ID #: APPROACH-001
• Status: Terminated
• Phase: N/A
• First received: September 8, 2009
• Last updated: April 4, 2017
• Start date: September 2009
• Est. completion date: November 2013

Study information

• Verified date: April 2017
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 329
• Est. completion date: November 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Myelopathy
• Degenerative Disc Disease
• Failed Back Surgery Syndrome
• Herniated Disc
• Intervertebral Disc Degeneration
• Intervertebral Disc Displacement
• Spinal Cord Diseases
• Spinal Cord Neoplasms
• Spinal Deformity
• Spinal Stenosis
• Spondylolisthesis
• Spondylolithesis

Intervention

Device:
• Bone graft substitute, autograft or allograft
spine fusion surgery utilizing any commercially available bone graft substitute(s), autograft or allograft

Locations

Country	Name	City	State
Hungary	Buda Health Center	Budapest
Netherlands	Isala Klinieken	Groot Wezenland	Zwolle
United States	St. Joseph's Hospital - Resurgeons Orthopedics	Atlanta	Georgia
United States	Carrollton Orthopedics	Carrollton	Georgia
United States	Physicians Research Options Spine Center	Las Vegas	Nevada
United States	Bluegrass Orthopedics & Hand Care Research	Lexington	Kentucky
United States	Montana Neuroscience Institute Foundation	Missoula	Montana
United States	Neurosurgical Associates	Nashville	Tennessee
United States	Brain & Spine of Texas	Plano	Texas
United States	UCSF	San Francisco	California
United States	PRESSD	Southfield	Michigan
United States	Syracuse Orthopedic Specialists	Syracuse	New York
United States	Henry Ford West Bloomfield Hospital	West Bloomfield	Michigan
United States	Arthritis & Joint Center - U. Mass. Memorial	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation	Apatech, Inc.

Countries where clinical trial is conducted

United States,  Hungary,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of successful radiographic fusion		6 months, 12 months & 24 months
Secondary	Maintenance or improvement in neurological status, as compared to baseline scores		6 months 12 months & 24 months
Secondary	Improvement of pain/function in comparison to pre-operative QOL scores		6 months, 12 months & 24 months