New back surgery shows promise for disc disease sufferers
NCT ID NCT01019057
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.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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77 people
The number who actually took part.
- Start date
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Nov 2009
- Finished
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Jun 2014
- 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.
Who is studied
Study populuation will be comprised of 50 patients across different cities in the United States.
- Ages
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40 years and older
- 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.
Show the full entry requirements Hide 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
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Center for Neurological Disorders, Texas Health Harris Methodist Fort Worth
Fort Worth, Texas, 76102, United States
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Coastal Orthopaedic Associates PA
Conway, South Carolina, 29526, United States
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Desert Institute for Spine Care, Surgical Specialty Hospital of Arizona
Phoenix, Arizona, 85020, United States
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Lovelace Medical Center
Albuquerque, New Mexico, 87102, United States
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McLeod Regional Medical Center
Florence, South Carolina, 29506, United States
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Neurosurgical Specialists, DePaul Medical Center
Norfolk, Virginia, 23510, United States
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North Florida Regional Medical Center
Gainesville, Florida, 32605, United States
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The Spine Institute, St. John's Health Center
Santa Monica, California, 90404, United States
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Other studies related to the condition(s) this trial covers.
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