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

Degenerative Disc Disease Clinical Trial

Official title:

A Single Blind, Multi-Center, Randomized, Prospective Clinical Study Comparing Optecure™ Autograft Extender to Autograft Only in Fusion of the Lumbar Spine

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00254852
• Other study ID #: CR04-004
• Status: Terminated
• Phase: N/A
• First received: November 15, 2005
• Last updated: November 20, 2013
• Start date: October 2005
• Est. completion date: August 2011

Study information

• Verified date: November 2013
• Source: Exactech
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Description:

Autograft (bone taken from one part of the body and placed in another site on the same individual) has long been considered the gold standard for lumbar spine fusion procedures. Unfortunately, there are complications involved with autograft harvest such as donor site morbidity, increased operating time, and limited supply. Therefore, the use of allograft (bone taken from one body and placed into another individual) as a graft extender has become an acceptable practice, especially in fusions of more than one level where larger quantities of graft material are needed.

In this study, comparisons will be made between patients who are randomized to having fusion with an allograft material (Optecure, Exactech, Inc.) mixed with an autograft to those patients who are randomized to having fusion with autograft alone.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 94
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Spondylolisthesis
• Stenosis

Intervention

Procedure:
• Posterior Lateral Fusion (PLF)
Posterior lateral fusion (PLF) of the lumbar spine
• Anterior Lumbar Interbody Fusion (ALIF)
Anterior lumbar interbody fusion (ALIF)
• Transforaminal lumbar interbody fusion (TLIF)
Transforaminal lumbar interbody fusion (TLIF)
• Posterior lumbar interbody fusion (PLIF)
Posterior lumbar interbody fusion (PLIF)
• Extreme lateral interbody fusion (XLIF)
Extreme lateral interbody fusion (XLIF)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Exactech

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic evidence of fusion on x-rays taken at each post-op visit		Immediate post-op, 6-week, 3-month, 6-month, 1-year, 2-year	No
Secondary	Oswestry Disability Index (ODI) completed at each visit		pre-operative, 6-week, 3-month, 6-month, 1-year, 2-year	No
Secondary	SF-12 patient health surveys completed at each visit		Pre-operative, 6-week, 3-month, 6-month, 1-year, 2-year	No
Secondary	Perceived pain noted on visual analog scales (VAS) at each visit		Pre-operative, 6-week, 3-month, 6-month, 1-year, 2-year	No