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A Study Comparing the Outcome of Anterior Lumbar Fusion and Total Lumbar Disc Replacement

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ClinicalTrials.gov Identifier: NCT03674190
Recruitment Status : Recruiting
First Posted : September 17, 2018
Last Update Posted : September 17, 2018
Sponsor:
Collaborator:
Yara Asterfjord
Information provided by (Responsible Party):
Svante Berg, Karolinska Institutet

Brief Summary:
Total lumbar disc replacement has previously been compared to posterior fusion of the lumbar spine, showing some favor towards total disc replacement. The study aims to compare total disc replacement to anterior fusion, sparing the muscles of the back and thus comparing the two different methods using the same surgical approach.

Condition or disease Intervention/treatment Phase
Disc Disease Degenerative Disk Degeneration Disc Disease Lumbar Procedure: Anterior Lumbar Interbody Fusion Procedure: Total Disc Replacement Not Applicable

Detailed Description:

A total of 170 patients are planned to be enrolled in the study. If the patients meet the inclusion criteria and accept to participate they will be randomized to either anterior lumbar fusion or total disc replacement. The method of choice will be blinded for the patients until the two year follow up is completed.

Follow-up: after one and two years. Questionnairs: ODI, VAS, EuroQol, and GA Flexion- Extension X-ray after one and two years Complications will be retrieved from the patient journals.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study Comparing the Outcome of Anterior Lumbar Fusion and Total Lumbar Disc Replacement
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Anterior Lumbar Interbody Fusion
Surgical treatment Anterior Lumbar Interbody Fusion
Procedure: Anterior Lumbar Interbody Fusion
Anterior Lumbar Fusion(ALIF)

Active Comparator: Total disc replacement
Surgical treatment total disc replacement in the lumbar spine
Procedure: Total Disc Replacement
Total Disc Replacement




Primary Outcome Measures :
  1. ODI, Oswestry Disability Index [ Time Frame: Two years ]
    ODI questionnaire


Secondary Outcome Measures :
  1. VAS, Visual Analogue Scale [ Time Frame: Two years ]
    VAS Scale

  2. Segment Mobility [ Time Frame: Two years ]
    Flexion Extension X-ray



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with disabling pain from degenerative disc disease(DDD) both clinical and radiological, in one or two segments of the lumbar spine from L4-S1, were prolonged conservative treatment has failed.
  • The patient should be able to understand swedish written and spoken.
  • The patient should be between the ages 18-65. The patient has to accept to participate in the study

Exclusion Criteria:

  • More than two degenerated segments.
  • Degeneration above the L4 segment.
  • Did not agree to participate in the study
  • Previous history of tumor, vertebral fracture, infection, lumbar fusion and dominating leg pain.
  • Need for posterior decompression
  • Pregnancy
  • Psychiatric illness or drug abuse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674190


Contacts
Contact: Yara Asterfjord, MD +4631891260 yara.asterfjord@spinecenter.se
Contact: Svante Berg, MD, PhD +46850902700 svante.berg@spinecenter.se

Locations
Sweden
Spine Center Göteborg Recruiting
Gothenburg, Sweden, SE-42130
Contact: Yara Asterfjord, MD    +4631891260    yara.asterfjord@spinecenter.se   
Contact: Svante Berg, MD, PhD    +46850902700    svante.berg@spinecenter.se   
Spine Center Göteborg Recruiting
Göteborg, Sweden, SE-42130
Contact: Yara Asterfjord, MD    +4631891260    yara.asterfjord@spinecenter.se   
Contact: Svante Berg    +46850902700    svante.berg@spinecenter.se   
Sponsors and Collaborators
Svante Berg
Yara Asterfjord
Investigators
Study Director: Svante Berg, MD, PhD Karolinska Institutet

Responsible Party: Svante Berg, MD, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03674190     History of Changes
Other Study ID Numbers: MollyMoa
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Spinal Diseases
Intervertebral Disc Degeneration
Bone Diseases
Musculoskeletal Diseases