Degenerative Conditions of the Lumbar SpineNCT02250248
AttraX® Putty vs. Autograft in XLIF®
A study testing AttraX Putty and Iliac Crest Bone Graft (ICBG) in people with Degenerative Conditions of the Lumbar Spine, run by NuVasive at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Degenerative Conditions of the Lumbar Spine
- What is being tested?
- AttraX Putty and Iliac Crest Bone Graft (ICBG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2014to 21 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AttraX® Putty vs. Autograft in eXtreme Lateral Interbody Fusion (XLIF®): A Prospective Randomized Single-Center Evaluation of Radiographic and Clinical Outcomes
The objective of this study is to evaluate the clinical success of AttraX Putty as a bone graft substitute for autograft in XLIF procedures.
Read the 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) autograft or AttraX Putty. To minimize bias, all consecutive patients at a given investigational site who meet eligibility requirements will be asked to consent to participate in the study whereby the biologic (ICBG autograft or AttraX Putty) will be randomly assigned. All subjects will be followed for 24 months following surgery to quantify the clinical and radiographic improvements of each biologic compared to baseline and in comparison with each other.
- Being tested
- AttraX Putty, Iliac Crest Bone Graft (ICBG)
- Keywords
- Degenerative disc disease, Lumbar spine
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AttraX PuttyBiological
Iliac Crest Bone Graft (ICBG)Other
Also called autograft
| Study group | Role | What they receive |
|---|---|---|
| AttraX Putty | Active comparator | Patient will be treated with AttraX Putty intraoperatively. Receives: Biological: AttraX Putty |
| Iliac Crest Bone Graft (ICBG) | Active comparator | Patients will be treated with ICBG harvested during surgery. Receives: Other: Iliac Crest Bone Graft (ICBG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number and percentage of subjects with radiographically apparent fusion 24 months.
The number and percentage of subjects with radiographically apparent fusion 24 months.
Measured: 24-months
Secondary outcomes (3)
The rate of complications attributable to the use of AttraX and ICBG autograft.
The rate of complications attributable to the use of AttraX and ICBG autograft.
Measured: Post-op to 24-months
The change in self-reported clinical outcomes scores from baseline through 24 month follow-up, including VAS (back, leg, and iliac crest pain), ODI, EQ5D, and SF-36.
The change in self-reported clinical outcomes scores from baseline through 24 month follow-up, including VAS (back, leg, and iliac crest pain), ODI, EQ5D, and SF-36.
Measured: Pre-op through 24-months
The morbidity associated graft harvest as measured by operative time, blood loss, length of hospital stay, postoperative pain, and infection rate.
The morbidity associated graft harvest as measured by operative time, blood loss, length of hospital stay, postoperative pain, and infection rate.
Measured: Surgery through 24-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startDec 2014
- Primary completion21 May 2021
- Study completion21 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Conditions of the Lumbar SpineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- NuVasive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cristiano M Menezes, M.D., Principal investigator, Lifecenter to Mater Dei Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02250248
- Sponsor's protocol ID
- NUVA.AX1401
- Status last verified
- Dec 2025
- First submitted
- 23 Sep 2014
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AttraX® Putty vs. Autograft in eXtreme Lateral Interbody Fusion (XLIF®): A Prospective Randomized Single-Center Evaluation of Radiographic and Clinical Outcomes
- ClinicalTrials.gov ID
- NCT02250248
- Acronym / sponsor ID
- NUVA.AX1401
- Keywords
- Degenerative disc disease, Lumbar spine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- NuVasiveIndustry (pharma, biotech, devices)
- Study start
- Dec 2014 (actual)
- Primary completion
- 21 May 2021 (actual)
- Study completion
- 21 May 2021 (actual)
- First posted
- 26 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) autograft or AttraX Putty. To minimize bias, all consecutive patients at a given investigational site who meet eligibility requirements will be asked to consent to participate in the study whereby the biologic (ICBG autograft or AttraX Putty) will be randomly assigned. All subjects will be followed for 24 months following surgery to quantify the clinical and radiographic improvements of each biologic compared to baseline and in comparison with each other.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AttraX Putty | Active comparator | Biological: AttraX PuttyPatient will be treated with AttraX Putty intraoperatively. |
| Iliac Crest Bone Graft (ICBG) | Active comparator | Other: Iliac Crest Bone Graft (ICBG)Patients will be treated with ICBG harvested during surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AttraX Putty | Biological | AttraX Putty |
| Iliac Crest Bone Graft (ICBG)Also: autograft | Other | Iliac Crest Bone Graft (ICBG) |
Primary outcome
The number and percentage of subjects with radiographically apparent fusion 24 months.
Time frame: 24-months
The number and percentage of subjects with radiographically apparent fusion 24 months.
3 secondary outcomes
The rate of complications attributable to the use of AttraX and ICBG autograft.
Time frame: Post-op to 24-months
The change in self-reported clinical outcomes scores from baseline through 24 month follow-up, including VAS (back, leg, and iliac crest pain), ODI, EQ5D, and SF-36.
Time frame: Pre-op through 24-months
The morbidity associated graft harvest as measured by operative time, blood loss, length of hospital stay, postoperative pain, and infection rate.
Time frame: Surgery through 24-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristiano M Menezes, M.D. principal investigator
Lifecenter to Mater Dei Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AttraX Putty and Iliac Crest Bone Graft (ICBG) in people with Degenerative Conditions of the Lumbar Spine, run by NuVasive at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number and percentage of subjects with radiographically apparent fusion 24 months. (time frame: 24-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025; AzTrials last refreshed its copy on 3 Nov 2026.