Status:
COMPLETED
AttraX® Putty vs. Autograft in XLIF®
Lead Sponsor:
NuVasive
Conditions:
Degenerative Conditions of the Lumbar Spine
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The objective of this study is to evaluate the clinical success of AttraX Putty as a bone graft substitute for autograft in XLIF procedures.
Detailed Description
This is a single-center, prospective, randomized study. Subjects will be recruited from patients already under the Investigator's care who are indicated for XLIF with iliac crest bone graft (ICBG) aut...
Eligibility Criteria
Inclusion
- Persistent back and/or leg pain unresponsive to conservative treatment for at least 6 months, unless surgical treatment is clinically indicated sooner
- Indicated for a single-level XLIF between L1 and L5 with bilateral percutaneous pedicle screws
- Objective evidence of primary diagnosis must be confirmed by appropriate imaging studies
- 18-80 years of age at the date of written informed consent
- Able to undergo surgery based on physical exam, medical history, and surgeon judgment
- Expected to survive at least 2 years beyond surgery
- Willing and able to return for post-treatment exams according to the follow-up called for in the protocol
- Signed and dated informed consent form
Exclusion
- Mental or physical condition that would limit the ability to comply with study requirements
- Spine abnormality requiring treatment at more than one level
- Previous failed fusion at any spinal level
- Prior fusion procedure at operative level (i.e., no revision of operative level)
- Prior adjacent level fusion (note: prior decompression is not an exclusion)
- Systemic or local infection; active or latent
- Diseases that significantly inhibit bone healing (e.g., prior diagnosis of osteoporosis, metabolic bone disease)
- Treatment with pharmaceuticals interfering with calcium metabolism
- Undergoing chemotherapy or radiation treatment
- 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)
- Involvement in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested)
- Significant general illness (e.g., HIV, active metastatic cancer of any type, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease)
- Immunocompromised or is being treated with immunosuppressive agents
- Pregnant, or plans to become pregnant during the study
- Subject is a prisoner
- Participating in another clinical study that would confound study data
- At risk to be non-compliant (e.g. (recently treated for) substance abuse, detainee, likely to immigrate)
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 21 2021
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT02250248
Start Date
December 1 2014
End Date
May 21 2021
Last Update
December 22 2025
Active Locations (1)
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1
Mater Dei Hospital
Barro Prêto, Minas Gerais, Brazil, 30140-093