APPROACH-001: Bone Graft Materials Observational Registry

• Sponsor: Baxter Healthcare Corporation (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00974623
• Collaborator: Apatech, Inc. (Industry)
• Enrollment: 329
• Locations: 14
• Duration (Months): 50
• Patients Per Site: 23.5
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

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

Study Design

• Study Type: Observational
• Actual Enrollment: 329 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Prospective Patient Registry for Bone Graft Substitutes in Spinal Fusion: Patient Outcomes and Use in Clinical Practice
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Nov 1, 2013

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Evidence of successful radiographic fusion [6 months, 12 months & 24 months]

Secondary Outcome Measures

1. Maintenance or improvement in neurological status, as compared to baseline scores [6 months 12 months & 24 months]

2. Improvement of pain/function in comparison to pre-operative QOL scores [6 months, 12 months & 24 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Baxter Healthcare Corporation
• Apatech, Inc.

Investigators

• Study Director: Huub Kreuwel, Ph.D, Director of Medical Affairs

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Baxter Healthcare Corporation
• ClinicalTrials.gov Identifier: NCT00974623
• Other Study ID Numbers: APPROACH-001
• First Posted: Sep 10, 2009
• Last Update Posted: Apr 5, 2017
• Last Verified: Apr 1, 2017

• Keywords provided by Baxter Healthcare Corporation: Bone growth substitute; Autograft; Allograft; Spine fusion
• Additional relevant MeSH terms: Spinal Cord Neoplasms; Spinal Stenosis; Intervertebral Disc Degeneration; Intervertebral Disc Displacement; Spinal Cord Diseases; Failed Back Surgery Syndrome

Study Results

No Results Posted as of Apr 5, 2017