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New putty may replace Patient's own bone in spine surgery

NCT ID NCT02250248

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

45 people

The number who actually took part.

Started

Dec 2014

Finished

May 2021

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • Mater Dei Hospital

    Barro Preto, Minas Gerais, 30140-093, Brazil

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