New putty may replace Patient's own bone in spine surgery
NCT ID NCT02250248
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a man-made bone graft putty (AttraX) works as well as using the patient's own bone for spinal fusion surgery. 45 adults with degenerative spine conditions were enrolled. The main goal was to see if the putty helped bones fuse together just as well as the standard method.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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45 people
The number who actually took part.
- Started
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Dec 2014
- Finished
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May 2021
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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 a single-level XLIF between L1 and L5 with bilateral percutaneous pedicle screws 3. Objective evidence of primary diagnosis must be confirmed by appropriate imaging studies 4. 18-80 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 Exclusion Criteria: 1. Mental or physical condition that would limit the ability to comply with study requirements 2. Spine abnormality requiring treatment at more than one level 3. Previous failed fusion at any spinal level 4. Prior fusion procedure at operative level (i.e., no revision of operative level) 5. Prior adjacent level fusion (note: prior decompression is not an exclusion) 6. Systemic or local infection; active or latent 7. Diseases that significantly inhibit bone healing (e.g., prior diagnosis of osteoporosis, metabolic bone disease) 8. Treatment with pharmaceuticals interfering with calcium metabolism 9. Undergoing chemotherapy or radiation treatment 10. 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) 11. Involvement in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested) 12. Significant general illness (e.g., HIV, active metastatic cancer of any type, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease) 13. Immunocompromised or is being treated with immunosuppressive agents 14. Pregnant, or plans to become pregnant during the study 15. Subject is a prisoner 16. Participating in another clinical study that would confound study data 17. At risk to be non-compliant (e.g. (recently treated for) substance abuse, detainee, likely to immigrate)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Mater Dei Hospital
Barro Preto, Minas Gerais, 30140-093, Brazil
More trials for these conditions
Other studies related to the condition(s) this trial covers.