Recruiting

InQu Bone GraftOutcomes of Degenerative Disc Disease Patients Treated With an Anterior-Only Fusion Using InQu Bone Graft

Sponsor:

Kansas Joint and Spine Institute

Code:

NCT01746212

Conditions

Degenerative Disc Disease

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

One-level or two-level anterior lumbar interbody fusion

InQu Bone Graft Extender and Substitute mixed with BMAC

Synthes Spinal Instrumentation

Study Details

Brief summary:

The purpose of this study is to report the radiographic, clinical, and functional outcomes of a consecutive series of patients diagnosed with single or bilateral degenerative disc disease between L4 and S1, that have been treated with an anterior lumbar interbody fusion (ALIF), anterior only surgical approach, and InQu Bone Graft Extender and Substitute for bony fusion and instrumentation.

Patients that decide to undergo an Anterior Lumbar Interbody Fusion (ALIF) surgery \[a surgical procedure that joins two or more lumbar vertebrae (small bones of the spine) together into one solid bony structure by approaching the spine through the abdomen (front of the body) and placing a bone graft in between the vertebral bodies where the disc usually lies\], are invited to participate in an orthopaedic research study.

This study will compare patients that have been treated with an anterior lumbar interbody fusion using InQu Bone Graft Extender \& Substitute to published data for a stand alone spinal fusion surgery, where InFuse bone graft is placed between the transverse processes \[small bony projections off the right and left side of each bone in your spine\] of the affected vertebrae.

X-rays, daily activities, and how patients are doing will be evaluated at specific time points during this study.

The hypothesis of this study is that patients diagnosed with degenerative disc disease treated with an anterior lumbar interbody fusion, anterior only surgical approach (incision through the abdomen), using InQu Bone Graft Extender and Substitute and instrumented fixation have comparable radiographic (x-rays), functional (daily activities), and clinical (how the patient is doing) outcomes when compared to published data for use of InFuse in stand-alone fusion.

Conditions

Degenerative Disc Disease

Study ID

NCT01746212

Start date

Dec, 2012

Status verified date

Dec, 2012

Completion date

May, 2015

Anticipated

Primary completion date

Mar, 2015

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria: Patients are eligible for this study if the following criteria are all met.

Patient will be surgically treated with an anterior lumbar interbody fusion, anterior only approach by one of the listed physician investigators
Must have had a structural problem potentially amendable to primary fusion at one or two levels
InQu Bone Graft Extender and Substitute will be used in the surgery
Had failed conservative care for longer than three (3) months
Had no psychological contraindications for surgery
Aged 18 to 70 years of age at the time of surgery

Exclusion Criteria: Patients are ineligible for this study if any one of the following criteria apply.

Patients that will not be surgically treated with an anterior lumbar interbody fusion, anterior only approach by one of the physician investigators
InQu Bone Graft Extender and Substitute will not be used in the surgery
Patient carries any one of the following diagnoses: spinal stenosis requiring decompression, isthmic spondylolisthesis, degenerative spondylolisthesis greater than three (3) millimeters, three or more degenerative levels, major deformity, have had a previous lumbar fusion, or if they have had a previous infection or tumor
Individuals that can not provide consent for themselves
Patients requiring revision surgery
Aged younger than 18 or older than 70 at the time of surgery
Patients will be excluded from participating in the study if, in the investigators' opinion, they will be unable to comply with study procedures

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Degenerative Disc Disease

Patients diagnosed with degenerative disc disease, meeting all eligibility requirements (please refer to inclusion/exclusion criteria), will be asked to participate in this study. A one-level or two-level anterior lumbar interbody fusion surgery using InQu Bone Graft Extender and Substitute, mixed with BMAC (bone marrow aspirate concentrate) as autograft, with Synthes Spinal Instrumentation will be recommended to the patient. If patients elect to proceed with surgery using the prescribed surgical components, they will be offered enrollment into the study. If the patient opts to use a different bone graft, or other spinal instrumentation, then the patient will not meet all inclusion criteria and will not be offered the opportunity to enroll in this study.

Interventions

One-level or two-level anterior lumbar interbody fusion

Patients electing to receive a one-level or two-level, anterior approach only (incision through the front), lumbar interbody fusion in order to treat degenerative disc disease (at one or two levels in the spine), and meeting all other inclusion criteria, are eligible for enrollment into the study.

InQu Bone Graft Extender and Substitute mixed with BMAC

Surgeries utilizing InQu Bone Graft Extender and Substitute during the anterior lumbar interbody fusion surgical procedure will be elected for inclusion. InQu will be mixed with BMAC (bone marrow aspirate concentrate), which will be prepared using the SmartPRep2 centrifuge. Patients opting to use a grafting alternative will not meet inclusion criteria, and will not be eligible to enroll in this study.

Synthes Spinal Instrumentation

Synthes Spinal Instrumentation will be used during surgery as spinal stabilization.

Primary outcome measure

Evidence of successful radiographic fusion at 1-year post-operative [ Time Frame: 12-months post-operative ]

Central Contacts and Locations

Central contacts

Jennifer Duong

316-858-1900 jduong@kjsi.com

Locations

Kansas Joint and Spine Institute

Recruiting

Wichita, Kansas, United States, 67226

Contacts

Jennifer Duong, BA

316-858-1900 jduong@kjsi.com

Mark C. Whitaker, MD

316-858-1900 cwhitaker@kjsi.com

Principal Investigator:

Mark C. Whitaker, MD

More Information

Sponsor

Kansas Joint and Spine Institute

Last update posted

Dec 10, 2012

Last verified

Dec, 2012

Keywords

Degenerative Disc Disease
InQu Bone Graft Extender and Substitute
Anterior Lumbar Interbody Fusion
Oswestry Disability Index
Visual Analog Scale
Stand-alone ALIF
Bone Marrow Aspirate Concentrate
Fusion rate
Disc Height
Mean Optical Density
Integrated Optical Density

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kansas Joint and Spine Institute on 2012-12-10.