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

Primary Purpose

Disc Disease Degenerative, Disk Degeneration, Disc Disease Lumbar

Status
Withdrawn
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Anterior Lumbar Interbody Fusion
Total Disc Replacement
Sponsored by
Svante Berg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disc Disease Degenerative

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Spine Center Göteborg
  • Spine Center Göteborg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Anterior Lumbar Interbody Fusion

Total disc replacement

Arm Description

Surgical treatment Anterior Lumbar Interbody Fusion

Surgical treatment total disc replacement in the lumbar spine

Outcomes

Primary Outcome Measures

ODI, Oswestry Disability Index
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)

Secondary Outcome Measures

VAS, Visual Analogue Scale
VAS Scale, VAS (Visual Analogue Scale, 0 no pain, 100 worst possible pain) of back and leg,collected from questionnaires
Segment Mobility
Flexion Extension X-ray
Patient reported back pain after two years in Swespine national registry
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

Full Information

First Posted
September 2, 2018
Last Updated
December 12, 2020
Sponsor
Svante Berg
Collaborators
Yara Asterfjord
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1. Study Identification

Unique Protocol Identification Number
NCT03674190
Brief Title
A Study Comparing the Outcome of Anterior Lumbar Fusion and Total Lumbar Disc Replacement
Official Title
A Study Comparing the Outcome of Anterior Lumbar Fusion and Total Lumbar Disc Replacement
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Difficult to find patients that accepted the study
Study Start Date
September 4, 2018 (Actual)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Svante Berg
Collaborators
Yara Asterfjord

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disc Disease Degenerative, Disk Degeneration, Disc Disease Lumbar

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anterior Lumbar Interbody Fusion
Arm Type
Experimental
Arm Description
Surgical treatment Anterior Lumbar Interbody Fusion
Arm Title
Total disc replacement
Arm Type
Active Comparator
Arm Description
Surgical treatment total disc replacement in the lumbar spine
Intervention Type
Procedure
Intervention Name(s)
Anterior Lumbar Interbody Fusion
Intervention Description
Anterior Lumbar Fusion(ALIF)
Intervention Type
Procedure
Intervention Name(s)
Total Disc Replacement
Intervention Description
Total Disc Replacement
Primary Outcome Measure Information:
Title
ODI, Oswestry Disability Index
Description
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)
Time Frame
Two years
Secondary Outcome Measure Information:
Title
VAS, Visual Analogue Scale
Description
VAS Scale, VAS (Visual Analogue Scale, 0 no pain, 100 worst possible pain) of back and leg,collected from questionnaires
Time Frame
Two years
Title
Segment Mobility
Description
Flexion Extension X-ray
Time Frame
Two years
Title
Patient reported back pain after two years in Swespine national registry
Description
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
Time Frame
Two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Svante Berg, MD, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Study Director
Facility Information:
Facility Name
Spine Center Göteborg
City
Gothenburg
ZIP/Postal Code
SE-42130
Country
Sweden
Facility Name
Spine Center Göteborg
City
Göteborg
ZIP/Postal Code
SE-42130
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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