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

Not Applicable

Withdrawn

• Conditions: Disc Disease Degenerative; Disc Disease Lumbar; Disk Degeneration
• Interventions: Procedure: Total Disc Replacement; Procedure: Anterior Lumbar Interbody Fusion

• Registration Number: NCT03674190
• Lead Sponsor: Svante Berg

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 Timeline

• Study First Submitted: 2018-09-02
• Study Start: 2018-09-04
• Study First Submitted QC: 2018-09-13
• Study First Posted: 2018-09-17
• Primary Completion: 2020-10
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-12
• Last Update Posted: 2020-12-16
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Total disc replacement	Total Disc Replacement	Surgical treatment total disc replacement in the lumbar spine
Anterior Lumbar Interbody Fusion	Anterior Lumbar Interbody Fusion	Surgical treatment Anterior Lumbar Interbody Fusion

Primary Outcome Measures

Name	Time	Method
ODI, Oswestry Disability Index	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Spine Center Göteborg; 🇸🇪 Göteborg, Sweden