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New back surgery study shows promise for disc disease patients

NCT ID NCT02617563

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

361 people

The number who actually took part.

Start date

Dec 2015

Finished

Nov 2024

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

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

18 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 ≥ 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

  • A-klinik

    Bratislava, 82108, Slovakia

  • A.O. Fatebenefratelli e Oftalmico

    Milan, 20123, Italy

  • AZ Delta

    Roeselare, 8800, Belgium

  • CHRU de Lille, Hôpital Roger Salengro

    Lille, 59037, France

  • Centro Hospitalar de Sao Joao

    Porto, 4200-319, Portugal

  • Department of Neurological Surgery, Chung-Ang University Hospital

    Seoul, 156-755, South Korea

  • Department of Orthopedics, Korea University Ansan Hospital

    Ansan, 425-707, South Korea

  • East Suffolk and North Essex NHS Foundation Trust (was formerly Ipswich Hospital NHS)

    Ipswich, IP45PD, United Kingdom

  • Glostrup Hospital

    Glostrup Municipality, 2600, Denmark

  • Hospital Escala Braga

    Braga, 4710-243, Portugal

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1199ABD, Argentina

  • Hospital L'Horta Manises

    Valencia, 46026, Spain

  • Hospital Naval General de Alta Especialidad

    Mexico City, 4470, Mexico

  • Hospital Universitario Cajuru

    Curitiba, 80050-350, Brazil

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008, Spain

  • Hull Royal Infirmary

    Hull, HU3 2JZ, United Kingdom

  • Hôpital Civil de Strasbourg (NHC)

    Eckbolsheim, 67201, France

  • Kepler Universitatsklinikum

    Linz, 4020, Austria

  • Klinikum Magdeburg

    Magdeburg, 39130, Germany

  • National Health Insurance Corporation Ilsan Hospital

    Gyeonggi-do, 10444, South Korea

  • Nizhny Novgorod Research Institute of Traumatology and Orthopedics of Public Health Ministry

    Nizhny Novgorod, 603155, Russia

  • Nový Hradec Králové

    Hradec Králové, 500 05, Czechia

  • Scientific Research Institute of Traumatology and Orthopedics

    Novosibirsk, 630091, Russia

  • Service de Neurochirurgie la Timone

    Marseille, France

  • Shangai Tenth People's Hospital

    Shanghai, 200072, China

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116011, China

  • West China Hospital Sichuan University

    Chengdu, Sichuan, 610041, China

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