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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03674190
Other study ID # MollyMoa
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date September 4, 2018
Est. completion date October 2022

Study information

Verified date December 2020
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date October 2022
Est. primary completion date October 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Intervention

Procedure:
Anterior Lumbar Interbody Fusion
Anterior Lumbar Fusion(ALIF)
Total Disc Replacement
Total Disc Replacement

Locations

Country Name City State
Sweden Spine Center Göteborg Göteborg
Sweden Spine Center Göteborg Gothenburg

Sponsors (2)

Lead Sponsor Collaborator
Svante Berg Yara Asterfjord

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) Two years
Secondary VAS, Visual Analogue Scale VAS Scale, VAS (Visual Analogue Scale, 0 no pain, 100 worst possible pain) of back and leg,collected from questionnaires Two years
Secondary Segment Mobility Flexion Extension X-ray Two years
Secondary 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 Two years
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