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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Recruitment Status : Withdrawn (Difficult to find patients that accepted the study)
First Posted : September 17, 2018
Last Update Posted : December 16, 2020
Sponsor:
Collaborator:
Yara Asterfjord
Information provided by (Responsible Party):
Svante Berg, Karolinska Institutet

Tracking Information
First Submitted Date  ICMJE September 2, 2018
First Posted Date  ICMJE September 17, 2018
Last Update Posted Date December 16, 2020
Actual Study Start Date  ICMJE September 4, 2018
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2019)
ODI, Oswestry Disability Index [ Time Frame: Two years ]
ODI questionnaire. ODI (Oswestry disability index, self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel, 0-5 zero indicating the least amount of disability and 5 indicating most severe disability)
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2018)
ODI, Oswestry Disability Index [ Time Frame: Two years ]
ODI questionnaire
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2019)
  • VAS, Visual Analogue Scale [ Time Frame: Two years ]
    VAS Scale, VAS (Visual Analogue Scale, 0 no pain, 100 worst possible pain) of back and leg,collected from questionnaires
  • Segment Mobility [ Time Frame: Two years ]
    Flexion Extension X-ray
  • Patient reported back pain after two years in Swespine national registry [ Time Frame: Two years ]
    GA (Global Assessment of back pain, patient-based evaluation of leg and back pain as compared to preoperatively,1-5, 1 disappeared and 5 worsened) ,collected from questionnaires
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2018)
  • VAS, Visual Analogue Scale [ Time Frame: Two years ]
    VAS Scale
  • Segment Mobility [ Time Frame: Two years ]
    Flexion Extension X-ray
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Comparing the Outcome of Anterior Lumbar Fusion and Total Lumbar Disc Replacement
Official Title  ICMJE A Study Comparing the Outcome of Anterior Lumbar Fusion and Total Lumbar Disc Replacement
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Disc Disease Degenerative
  • Disk Degeneration
  • Disc Disease Lumbar
Intervention  ICMJE
  • Procedure: Anterior Lumbar Interbody Fusion
    Anterior Lumbar Fusion(ALIF)
  • Procedure: Total Disc Replacement
    Total Disc Replacement
Study Arms  ICMJE
  • Experimental: Anterior Lumbar Interbody Fusion
    Surgical treatment Anterior Lumbar Interbody Fusion
    Intervention: Procedure: Anterior Lumbar Interbody Fusion
  • Active Comparator: Total disc replacement
    Surgical treatment total disc replacement in the lumbar spine
    Intervention: Procedure: Total Disc Replacement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: December 12, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: September 13, 2018)
170
Estimated Study Completion Date  ICMJE October 2022
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03674190
Other Study ID Numbers  ICMJE MollyMoa
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Svante Berg, Karolinska Institutet
Study Sponsor  ICMJE Svante Berg
Collaborators  ICMJE Yara Asterfjord
Investigators  ICMJE
Study Director: Svante Berg, MD, PhD Karolinska Institutet
PRS Account Karolinska Institutet
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP