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

Exactech

Status

Terminated

Conditions

Degenerative Disc Disease

Spondylolisthesis

Stenosis

Treatments

Procedure: Posterior Lateral Fusion (PLF)

Procedure: Posterior lumbar interbody fusion (PLIF)

Procedure: Extreme lateral interbody fusion (XLIF)

Procedure: Anterior Lumbar Interbody Fusion (ALIF)

Procedure: Transforaminal lumbar interbody fusion (TLIF)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00254852

CR04-004

Details and patient eligibility

About

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).

Full 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.

Enrollment

94 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

94 participants in 2 patient groups

Active Comparator group

Description:

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

Treatment:

Procedure: Transforaminal lumbar interbody fusion (TLIF)

Procedure: Extreme lateral interbody fusion (XLIF)

Procedure: Anterior Lumbar Interbody Fusion (ALIF)

Procedure: Posterior lumbar interbody fusion (PLIF)

Procedure: Posterior Lateral Fusion (PLF)

Active Comparator group

Description:

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

Treatment:

Procedure: Transforaminal lumbar interbody fusion (TLIF)

Procedure: Extreme lateral interbody fusion (XLIF)