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New bone graft shows promise in spine fusion surgery

NCT ID NCT00948532

Disease control Sponsor: NuVasive Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at using Osteocel Plus, a bone graft material, in a type of spine surgery called XLIF for people with degenerative disc disease and back pain. 104 adults aged 18-80 who needed fusion of one or two lower spine segments were enrolled. The main goal was to see how many achieved solid bone fusion within 24 months after surgery, and how long it took. Results were compared to historical data for other graft options.

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.

Participants

104 people

The number who actually took part.

Start date

Mar 2009

Finished

Oct 2012

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.

Who is studied

Existing clinic patients

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 six (6) months, unless clinically indicated earlier 2. Indicated for interbody fusion of one or two contiguous lumbar segments (L1 to L5) 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. Patient has a mental or physical condition that would limit the ability to comply with study requirements 2. Lumbar spine abnormality requiring treatment at more than two levels 3. Systemic or local infection; active or latent 4. Previous failed fusion at the operative level 5. Diseases that significantly inhibit bone healing (osteoporosis, metabolic bone disease, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease) 6. Undergoing chemotherapy or radiation treatment, or 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) 7. Pregnant, or plans to become pregnant during the study 8. Subject is a prisoner 9. Involvement in active litigation relating to the spine (worker's compensation claim is allowed if it is not contended) 10. A significant general illness (e.g., HIV, active metastatic cancer of any type) is present; subject is immunocompromised or is being treated with immunosuppressive agents 11. Participating in another clinical study that would confound study data

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Conditions

The condition(s) this trial relates to.

Back Pain intervertebral disk degenerative disorder lumbar disk degenerative disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Back pain Degenerative disc disease

Contacts and locations

Locations

  • Broward Spine Institute

    Hollywood, Florida, 33021, United States

  • Buffalo Spine Surgery, Kenmore Mercy

    Lockport, New York, 14094, United States

  • Columbia Orthopaedic Group, Boone Hospital Center

    Columbia, Missouri, 65205, United States

  • Duke University Medical Center

    Chapel Hill, North Carolina, 27710, United States

  • Indiana Center for Neurosurgery

    Indianapolis, Indiana, 46219, United States

  • Pinnacle Orthopaedics, Wellstone Kennestone Hospital

    Marietta, Georgia, 30060, United States

  • Shiley Center for Orthopaedic, Scripps Green Hospital

    La Jolla, California, 92037, United States

  • South Florida Spine Institute, Mount Sinai Medical Center

    Miami Beach, Florida, 33140, United States

  • Southeastern Spine Center, Doctors Hospital of Sarasota

    Sarasota, Florida, 34232, United States

  • Spine Midwest, St. Mary's Health Center

    Jefferson City, Missouri, 65101, United States

  • The Spine Center of DuPage Medical Group, Edward Hospital

    Naperville, Illinois, 60540, United States

  • USF, Tampa General Hospital

    Tampa, Florida, 33606, United States

  • Western Regional Center for Brain & Spine Surgery, Surgery Center of S. Nevada

    Las Vegas, Nevada, 89109, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.