MedDataX Logo

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

NCT ID: NCT00254852

Last Updated: 2013-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2011-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stenosis Spondylolisthesis Degenerative Disc Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Primary lumbar fusion Demineralized Bone Matrix DBM Optecure Allograft Autograft Lumbar fusion Interbody fusion Instrumented fusion Non-instrumented fusion Exactech Spinal fusion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

O

This treatment arm includes autograft harvested from local bone and / or the iliac crest, supplemented with a demineralized bone matrix (DBM) autograft extender, Optecure.

Group Type ACTIVE_COMPARATOR

Posterior Lateral Fusion (PLF)

Intervention Type PROCEDURE

Posterior lateral fusion (PLF) of the lumbar spine

Anterior Lumbar Interbody Fusion (ALIF)

Intervention Type PROCEDURE

Anterior lumbar interbody fusion (ALIF)

Transforaminal lumbar interbody fusion (TLIF)

Intervention Type PROCEDURE

Transforaminal lumbar interbody fusion (TLIF)

Posterior lumbar interbody fusion (PLIF)

Intervention Type PROCEDURE

Posterior lumbar interbody fusion (PLIF)

Extreme lateral interbody fusion (XLIF)

Intervention Type PROCEDURE

Extreme lateral interbody fusion (XLIF)

A

This treatment arm includes autograft harvested from local bone and / or the iliac crest.

Group Type ACTIVE_COMPARATOR

Posterior Lateral Fusion (PLF)

Intervention Type PROCEDURE

Posterior lateral fusion (PLF) of the lumbar spine

Anterior Lumbar Interbody Fusion (ALIF)

Intervention Type PROCEDURE

Anterior lumbar interbody fusion (ALIF)

Transforaminal lumbar interbody fusion (TLIF)

Intervention Type PROCEDURE

Transforaminal lumbar interbody fusion (TLIF)

Posterior lumbar interbody fusion (PLIF)

Intervention Type PROCEDURE

Posterior lumbar interbody fusion (PLIF)

Extreme lateral interbody fusion (XLIF)

Intervention Type PROCEDURE

Extreme lateral interbody fusion (XLIF)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Posterior Lateral Fusion (PLF)

Posterior lateral fusion (PLF) of the lumbar spine

Intervention Type PROCEDURE

Anterior Lumbar Interbody Fusion (ALIF)

Anterior lumbar interbody fusion (ALIF)

Intervention Type PROCEDURE

Transforaminal lumbar interbody fusion (TLIF)

Transforaminal lumbar interbody fusion (TLIF)

Intervention Type PROCEDURE

Posterior lumbar interbody fusion (PLIF)

Posterior lumbar interbody fusion (PLIF)

Intervention Type PROCEDURE

Extreme lateral interbody fusion (XLIF)

Extreme lateral interbody fusion (XLIF)

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

PLF ALIF TLIF PLIF XLIF

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Exactech

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Amir Fayyazi, MD

Role: PRINCIPAL_INVESTIGATOR

VSAS Orthopedics

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Memorial Orthopaedic Surgical Group

Long Beach, California, United States

Site Status

University of California, San Diego

San Diego, California, United States

Site Status

Slocum Dickson Medical Group

New Hartford, New York, United States

Site Status

State University of New York, Upstate Medical University

Syracuse, New York, United States

Site Status

NeuroSpine Solutions, P.C.

Bristol, Tennessee, United States

Site Status

Madigan Army Medical Center

Tacoma, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CR04-004

Identifier Type: -

Identifier Source: org_study_id