Condition category
Musculoskeletal Diseases
Date applied
28/11/2011
Date assigned
15/12/2011
Last edited
20/06/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 3

Trial website

Contact information

Type

Scientific

Primary contact

Ms Kelli Howell

ORCID ID

Contact details

7475 Lusk Blvd
San Diego
92121
United States of America

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

Non randomised controlled trial

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 Investigator’s standard of care.

Intervention type

Other

Phase

Not Applicable

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

7475 Lusk Blvd
San Diego
92121
United States of America

Sponsor information

Organisation

NuVasive, Inc. (USA)

Sponsor details

c/o Rebecca Smith
Manager
Clinical Resources
7475 Lusk Blvd
San Diego
02141
United States of America

Sponsor type

Industry

Website

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

Publication citations

Additional files

Editorial Notes