Plain English Summary
Background and study aims
A bone graft is a material that is placed between your spine bones (vertebrae) to help them fuse together. A bone graft may come from a piece of your own bone (autograft), a donor graft (allograft), or a graft substitute (synthetic or man-made material). AttraX Putty is a synthetic replacement for bone that may be used in spinal fusions without needing autograft. AttraX Putty has a combination of materials that help with bone growth. The aim of this study is to find out how effective AttraX Putty is as a bone graft substitute compared with the other options that are currently available for spinal fusions. We are interested in finding out whether there are differences in spine fusion rates and pain levels for the different types of bone graft.
Who can participate?
Patients aged 18-70 undergoing spinal fusion surgery.
What does the study involve?
Before surgery the participants undergo tests to document their health and pain. Participants attend follow-up visits to see their surgeon 2 weeks, 3 months, 6 months, 12 months, and 24 months after surgery. If the spine is not considered fused by the 12-month visit then a second CT scan is required at 24 months . All follow-up visits are scheduled at the same intervals as the standard follow-up schedule and take about 15 minutes longer than a regular outpatient visit (for the completion of questionnaires).
What are the possible benefits and risks of participating?
Participants will not incur any additional costs beyond those normally associated with this type of surgery and follow-up visits. Participants will not be compensated directly for their participation in the study. Participants will have one or more scans which use radiation.
Where is the study run from?
NuVasive, Inc. (USA).
When is the study starting and how long is it expected to run for?
December 2011 to December 2013.
Who is funding the study?
NuVasive, Inc. (USA).
Who is the main contact?
Kelli Howell
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NUVA.AX1101
Study information
Scientific title
AttraX® Putty in spinal interbody fusion: Evaluation of radiographic and clinical outcomes
Acronym
NUVA.AX1101
Study hypothesis
1. To evaluate the fusion rate following the use of AttraX®Putty in spinal fusion procedures performed at one or two contiguous level(s) of the cervical and lumbar spine.
2. To evaluate the complication rate associated with the use of AttraX®Putty compared to published and/or retrospective data for autograft, allograft, synthetics, bone morphogenic protein (BMP), or other graft alternatives.
3. To evaluate and identify any relationships between clinical outcomes (pain and function) and radiographic outcomes (fusion rate)
Ethics approval
Not provided at time of registration
Study design
Prospective non-randomized multi-arm observational study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Degenerative conditions of the lumbar and cervical spine
Intervention
1. Study Arm: Anterior Approach Cervical Interbody Fusion(ACDF)
ACDF with CoRoent® Small Contoured or Small Lordotic Plus (SLP) and AttraX® Putty in the interbody space, and with NuVasive Helix ACPTM
2. Study Arm: Anterior Approach Lumbar Interbody Fusion
eXtreme Lateral Interbody Fusion (XLIF) using CoRoent XL or Anterior Lateral Interbody Fusion (ALIF) using BrigadeTM or XLR implant(s) and AttraX® Putty in the interbody space, and with bilateral posterior stabilization by Armada® or SpheRx® pedicle screw system.
3. Study Arm: Posterior Approach Lumbar Interbody Fusion
Bilateral or unilateral Posterior Lumbar Interbody Fusion (PLIF) or Transforaminal Lumbar Interbody Fusion (TLIF) using CoRoent Large or Large Oblique (LO) implant(s) (respectively) and AttraX® Putty in the interbody space, and with bilateral posterior stabilization by Armada or SpheRx pedicle screw system.
All postoperative restrictions and rehabilitation of the subject are per the Investigators standard of care.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
The radiographic fusion rates at 12 months and 24 months
Secondary outcome measures
1. The complication rate attributable to the use of AttraX® Putty
2. The evaluation of angular displacement on flexion / extension films at the 6-, 12-, and 24-month follow-up visits
3. The evaluation of bridging bone on computerised tomography (CT) at 12- and 24-month (as required) follow-up visits
4. Preservation of interverterbal disc height over time
5. The change in American Spinal Injury Association (ASIA) score from baseline at each follow-up visit
6. The change in subject self-reported pain scores Visual Analogue Scale (VAS) from baseline at each follow-up visit
7. The change in Neck Disability Index (NDI) or Oswestry Disability Index (ODI) scores from baseline at each follow-up visit
8. The change in SF-36 scores from baseline at each follow-up visit
9. Patient satisfaction at each follow-up visit
10. The number of subjects returning to employment and the mean time of return to employment (as applicable)
Overall trial start date
01/12/2011
Overall trial end date
01/12/2013
Reason abandoned
Eligibility
Participant inclusion criteria
1. Persistent arm pain unresponsive to conservative treatment for at least 6 weeks or persistent back and/or leg pain unresponsive to conservative treatment for at least 6 months, unless surgical treatment is clinically indicated sooner
2. Indicated for anterior cervical discectomy and fusion (ACDF), anterior lumbar interbody fusion (ALIF or XLIF), or posterior lumbar interbody fusion (PLIF or TLIF) at one or two contiguous motion segments (C3 to T1 in the cervical spine or L1 to S1 in the lumbar spine)
3. Objective evidence of primary diagnosis must be confirmed by appropriate imaging studies
4. 18-70 years of age at the date of written informed consent
5. Able to undergo surgery based on physical exam, medical history and surgeon judgment
6. Expected to survive at least 2 years beyond surgery
7. Willing and able to return for post-treatment exams according to the follow-up called for in the protocol
8. Signed and dated informed consent form
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150
Participant exclusion criteria
1. Mental or physical condition that would limit the ability to comply with study requirements
2. Previous failed fusion at any spinal level
3. Prior fusion procedure at operative level(s) (i.e. no revision of prior level)
4. Prior instrumented fusion at level(s) adjacent to operative level(s)
5. Systemic or local infection; active or latent
6. Diseases that significantly inhibit bone healing (e.g., osteoporosis, metabolic bone disease)
7. Treatment with pharmaceuticals interfering with calcium metabolism
8. Undergoing chemotherapy or radiation treatment
9. Chronic use of steroids (defined as more than 6 weeks of steroid use within 12 months of surgery, other than episodic use or inhaled corticosteroids)
10. Involvement in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested)
11. Significant general illness [e.g., human immunodeficiency virus (HIV), active metastatic cancer of any type, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease]
12. Immunocompromised or is being treated with immunosuppressive agents
13. Pregnant, or plans to become pregnant during the study
14. A prisoner
15. Participating in another clinical study that would confound study data
Recruitment start date
01/12/2011
Recruitment end date
01/12/2013
Locations
Countries of recruitment
Germany, United Kingdom
Trial participating centre
NuVasive, Inc.
San Diego
92121
United States of America
Funders
Funder type
Industry
Funder name
NuVasive, Inc. (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary