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

Disc Disease Degenerative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03674190
• Other study ID #: MollyMoa
• Status: Withdrawn
• Phase: N/A
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Disc Disease Degenerative
• Disc Disease Lumbar
• Disk Degeneration
• Intervertebral Disc Degeneration
• Spinal Diseases

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