New back surgery study shows promise for disc disease patients
NCT ID NCT02617563
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study followed 361 adults with degenerative disc disease who had minimally invasive spinal fusion surgery. The goal was to see how well these procedures reduce disability and pain over 5 years. Researchers compared different surgical approaches to find which works best for patients with or without a slipped vertebra.
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
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361 people
The number who actually took part.
- Start date
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Dec 2015
- Finished
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Nov 2024
- 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
361 patients suffering from lumbar degenerative disc disease (DDD) were enrolled over a period of 42 months in 27 sites located in Europe, Latin America, and Asia Pacific.
- Ages
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18 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 ≥ 18 years of age (or minimum age as required by local regulations) * Patient has degenerative disc disease and an indication for a single or double level instrumented lumbar fusion for the treatment * Patient agrees to participate in the study and is able to sign the Data Release Form/Informed Consent * The procedure planned for the patient complies with the labeling of the Devices that may be used in the surgical procedure as described in the section Medical Devices of the Clinical Investigation Plan * Patient is planned to be submitted to a minimally invasive fusion procedure using a posterior (PLIF, TLIF, MIDLF) or anterolateral (OLIF, ALIF, DLIF ) technique\* \*For a double level instrumented fusion, the same procedure must be used for both levels. * The patient is willing and is able to perform study procedures and required follow-up visits. Exclusion Criteria: * Patient that has already undergone a lumbar fusion surgery * Patient that has already undergone open lumbar surgery other than standard decompression surgery * Indications for the procedure other than degenerative spine disease like: Osteoporotic vertebral fractures, Spine trauma fractures or Spine tumor * Illiterate or vulnerable patients (e.g. minors, participants incapable of judgment or participants under tutelage) * Concurrent participation in another clinical study that may confound study results.
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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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A-klinik
Bratislava, 82108, Slovakia
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A.O. Fatebenefratelli e Oftalmico
Milan, 20123, Italy
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AZ Delta
Roeselare, 8800, Belgium
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CHRU de Lille, Hôpital Roger Salengro
Lille, 59037, France
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Centro Hospitalar de Sao Joao
Porto, 4200-319, Portugal
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Department of Neurological Surgery, Chung-Ang University Hospital
Seoul, 156-755, South Korea
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Department of Orthopedics, Korea University Ansan Hospital
Ansan, 425-707, South Korea
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East Suffolk and North Essex NHS Foundation Trust (was formerly Ipswich Hospital NHS)
Ipswich, IP45PD, United Kingdom
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Glostrup Hospital
Glostrup Municipality, 2600, Denmark
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Hospital Escala Braga
Braga, 4710-243, Portugal
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Hospital Italiano de Buenos Aires
Buenos Aires, C1199ABD, Argentina
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Hospital L'Horta Manises
Valencia, 46026, Spain
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Hospital Naval General de Alta Especialidad
Mexico City, 4470, Mexico
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Hospital Universitario Cajuru
Curitiba, 80050-350, Brazil
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Hospital Universitario Marques de Valdecilla
Santander, 39008, Spain
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Hull Royal Infirmary
Hull, HU3 2JZ, United Kingdom
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Hôpital Civil de Strasbourg (NHC)
Eckbolsheim, 67201, France
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Kepler Universitatsklinikum
Linz, 4020, Austria
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Klinikum Magdeburg
Magdeburg, 39130, Germany
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National Health Insurance Corporation Ilsan Hospital
Gyeonggi-do, 10444, South Korea
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Nizhny Novgorod Research Institute of Traumatology and Orthopedics of Public Health Ministry
Nizhny Novgorod, 603155, Russia
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Nový Hradec Králové
Hradec Králové, 500 05, Czechia
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Scientific Research Institute of Traumatology and Orthopedics
Novosibirsk, 630091, Russia
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Service de Neurochirurgie la Timone
Marseille, France
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Shangai Tenth People's Hospital
Shanghai, 200072, China
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The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011, China
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West China Hospital Sichuan University
Chengdu, Sichuan, 610041, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a growth factor from donor bone improve spinal fusion?
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- Bone scan may help avoid unnecessary back surgery