AttraX® Putty in spinal fusion | Not Recruiting
AttraX® Putty in spinal fusion | Not Recruiting
AttraX® Putty in spinal fusion
NUVA.AX1101

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Medical Conditions
  • Degenerative conditions of the lumbar and cervical spine
Primary Contact Details
Recruitment Status
Not Recruiting
Trial source and source ID number
ISRCTN38726728

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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
Research Details
  • 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)
Phase
Sorry, this information is not available
Study Design
Prospective non-randomized multi-arm observational study
Study Type
Observational
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 Investigator’s standard of care.

Intervention Type
Procedure/Surgery
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)
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
Adult
Who Can Participate
Patient
Number of Participants
150
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 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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
92121
Trial Contact(s)
Primary Trial Contact
Ms Kelli Howell
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Germany, United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
AttraX® Putty in spinal interbody fusion: Evaluation of radiographic and clinical outcomes
EudraCT Number
Sorry, this information is not available
Funder(s)
  • NuVasive, Inc. (USA)
Other Study ID Numbers
NUVA.AX1101
Sponsor(s)
NuVasive, Inc. (USA)
Key Dates

Recruitment Start Date

01 Dec 2011

Recruitment End Date

01 Dec 2013

Trial Start Date

01 Dec 2011

Trial End Date

01 Dec 2013

Date added to source

15 Dec 2011

Date updated in source

10 Dec 2015