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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00974623
Other study ID # APPROACH-001
Secondary ID
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
Health authority
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.

Study Design


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
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