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

NCT01746212 | Unknown

• 1 other identifier: InQu ALIF
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

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

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

Outcome Measures

Primary Outcomes (1)

• Evidence of successful radiographic fusion at 1-year post-operative

  X-rays and CTs will be analyzed for fusion based on the following criteria: 1. Bridging trabecular bone connecting the two vertebral bodies either through the dowels or around the dowels as evaluated by thin-cut CT scans and radiographs; 2. No angular motion of 5 degrees or more on dynamic plain radiographs; 3. No sagittal translation of more than 3 mm on dynamic plain radiographs; and 4. No radiolucencies that involve more than half of the interfaces between the dowels and the host vertebral end plates. Criteria is based on the Burkus, Transfelt, et. al study titled "Clinical and Radiographic Outcomes of Anterior Lumbar Interbody Fusion Using Recombinant Human Bone Morphogenetic Protein-2."

  12-months post-operative

Secondary Outcomes (4)

• Improvement in Oswestry Disability Index Score (1-year)

  Change from baseline to 12-months post-operative

• Improvement in Oswestry Disability Index Scores (2-years)

  Change from baseline to 24-month post-operative

• Improvement in Visual Analog Scale Scores (1-year)

  Change from baseline to 12-months post-operative

• Improvement in Visual Analog Scale Scores (2-years)

  Change from baseline to 24-months post-operative

Other Outcomes (5)

• Surgical Outcomes

  At time of surgery

• Radiographic Measurements at 6-months post-operative

  Change from baseline to 6-months post-operative

• Radiographic Measurements at 12-months post-operative

  Change from baseline to 12-months post-operative

Study Arms (1)

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.

Procedure: One-level or two-level anterior lumbar interbody fusion; Biological: InQu Bone Graft Extender and Substitute mixed with BMAC; Device: Synthes Spinal Instrumentation

Interventions

One-level or two-level anterior lumbar interbody fusion PROCEDURE

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.

Also known as: ALIF

Degenerative Disc Disease

InQu Bone Graft Extender and Substitute mixed with BMAC BIOLOGICAL

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.

Also known as: InQu, BMAC, SmartPRep2 centrifuge

Degenerative Disc Disease

Synthes Spinal Instrumentation DEVICE

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

Also known as: ATB Plate, Peek Cage, SynFix-LR

Degenerative Disc Disease

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Target population included adult patients from the normal patient population seen at Kansas Joint and Spine Institute, currently also known as Kansas Spine Specialists, that have the ability to provide informed consent without assistance. Each patient that is qualified for an anterior lumbar interbody fusion, with an anterior only approach, will be offered the InQu Bone Graft Extender and Substitute as the bone graft the investigator will use in surgery. Patients that proceed with surgical intervention, and that meet all inclusion/exclusion criteria, will be offered enrollment into the study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kansas Joint and Spine Institute: lead
• National Center of Innovation for Biomaterials in Orthopaedic Research: collaborator
• ISTO Technologies, Inc.: collaborator

Study Sites (2)

Kansas Joint and Spine Institute

Wichita, Kansas, 67226, United States

RECRUITING

National Center of Innovation for Biomaterials in Orthopaedic Research

Wichita, Kansas, 67226, United States

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Mark C Whitaker, MD

  Kansas Joint and Spine Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Duong

CONTACT

316-858-1900; jduong@kjsi.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 3, 2012
• First Posted: December 10, 2012
• Study Start: December 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: May 1, 2015
• Last Updated: December 10, 2012

Record last verified: 2012-12

Locations

US (2)