Evaluation of Radiographic and Patient Outcomes Following Lumbar Spine Fusion Using Demineralized Bone Matrix (DBM) Mixed With Autograft

Stopped early · Not applicable

Conditions studied: Stenosis, Spondylolisthesis, Degenerative Disc Disease

In brief

The purpose of this study is to compare Optecure™ as an autograft extender (treatment) to autograft alone (control) in patients undergoing 1 or 2 level fusion of the lumbar spine(one level is defined as two adjacent vertebrae), L2 and below. The primary endpoint will be the assessment of fusion by evaluation of x-rays taken following surgery at each visit. The x-ray evaluation will be conducted by a radiologist who is blinded to the type of treatment each patient has received. Subjects will be seen at 6 weeks, 3 months, 6 months, 12 months, and 24 months postoperative (post-op). Questionnaires and x-rays will be completed at each visit and a computed tomography (CT) scan will be taken at the 12 month visit(and used to aid in assessment of bridging bone, where appropriate).

Key facts

Study ID

NCT00254852

Run by

Exactech

People needed

94

Starts

2005-10-01

Expected to finish

2011-08-01

Last updated by the study team

2013-11-21

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is indicated for primary lumbar fusion of 1 or 2 segments, L2 to S1
• Patient is willing to be blindly randomized to treatment or control and remain blinded for 2 years of follow-up
• Patient is at least twenty-one (21) years of age
• Patient is expected to survive at least 2 years beyond surgery
• Patient is willing to participate by complying with pre- and postoperative visit requirements, including: completion of questionnaires, functional performance tests, and radiographs/CT scan
• Patient is willing and able to review and sign a study Informed Consent form

You may not qualify if…

• Patient has a mental or physical condition that would invalidate evaluation results
• Patient is pregnant
• Patient is a prisoner
• Patient has a systemic infection or infection at the proposed surgical site
• Patient has osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated
• Patient has a disease of bone metabolism
• Patient is undergoing chemotherapy or radiation treatment
• Patient is currently involved in a study of another product for a similar purpose
• Patient requires post-op management with nonsteroidal anti-inflammatory drugs (NSAIDs)

Where it is running

• Memorial Orthopaedic Surgical Group — Long Beach, California, United States
• University of California, San Diego — San Diego, California, United States
• Slocum Dickson Medical Group — New Hartford, New York, United States
• State University of New York, Upstate Medical University — Syracuse, New York, United States
• NeuroSpine Solutions, P.C. — Bristol, Tennessee, United States
• Madigan Army Medical Center — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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