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New back surgery shows promise for disc disease sufferers

NCT ID NCT01019057

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a new type of spine surgery called ILIF for people with degenerative disc disease, a condition where spinal discs wear down causing pain and nerve issues. 77 adults over 40 who had not improved with other treatments received the surgery. Researchers measured changes in pain and disability over 2 years to see if the procedure helped.

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

77 people

The number who actually took part.

Start date

Nov 2009

Finished

Jun 2014

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

Study populuation will be comprised of 50 patients across different cities in the United States.

Ages

40 years and older

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: * Patient is over 40 years of age; * Patient is diagnosed with single-level lumbar degenerative disc disease between L1-L2 and L4-L5 with evidence of disc collapse and symptomatic claudication with or without back pain and requires surgical intervention; * Patient is unresponsive to conservative treatment greater than or equal to six month 6 months, or exhibits progressive neurological symptoms in the face of conservative treatment; * Patient is willing and able to comply with the requirements defined in the protocol for the duration of the study; * Patient has signed and dated Informed Consent. Exclusion Criteria: * Patients with lumbar pathologies requiring surgical treatment at more than one level; * Patients with spondylolisthesis \> grade 1; * Patients with lytic spondylolisthesis or a defect of the pars interarticularis; * Patients with prior lumbar surgery at or adjacent to the operative level; * Patients with spinal metastases or active spinal tumor malignancy; * Progressive neuromuscular disease, e.g., muscular dystrophy, multiple sclerosis; * Present chronic steroid use; * Patients with rheumatoid arthritis or other autoimmune disease; * Patients who are pregnant or interested in becoming pregnant within the follow-up period of the study; * Patients with a history of substance abuse; * Patients involved in active spinal litigation; * Patients receiving workman's compensation for spinal conditions; * Patients who are mentally incompetent; * Patients who are incarcerated; * Patients who are unwilling or unable to comply with the follow-up protocol schedule of visits and assessments.

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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

  • Center for Neurological Disorders, Texas Health Harris Methodist Fort Worth

    Fort Worth, Texas, 76102, United States

  • Coastal Orthopaedic Associates PA

    Conway, South Carolina, 29526, United States

  • Desert Institute for Spine Care, Surgical Specialty Hospital of Arizona

    Phoenix, Arizona, 85020, United States

  • Lovelace Medical Center

    Albuquerque, New Mexico, 87102, United States

  • McLeod Regional Medical Center

    Florence, South Carolina, 29506, United States

  • Neurosurgical Specialists, DePaul Medical Center

    Norfolk, Virginia, 23510, United States

  • North Florida Regional Medical Center

    Gainesville, Florida, 32605, United States

  • The Spine Institute, St. John's Health Center

    Santa Monica, California, 90404, United States

More trials for these conditions

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