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

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.

Study Overview

• Status: Withdrawn
• Conditions: Disk Degeneration; Disc Disease Degenerative; Disc Disease Lumbar
• Intervention / Treatment: Procedure: Anterior Lumbar Interbody Fusion; Procedure: Total Disc Replacement

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: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, SE-42130
    • Spine Center Göteborg
  • Göteborg, Sweden, SE-42130
    • Spine Center Göteborg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anterior Lumbar Interbody Fusion; Surgical treatment Anterior Lumbar Interbody Fusion	Procedure: Anterior Lumbar Interbody Fusion; Anterior Lumbar Fusion(ALIF)
Active Comparator: Total disc replacement; Surgical treatment total disc replacement in the lumbar spine	Procedure: Total Disc Replacement; Total Disc Replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Segment Mobility	Flexion Extension X-ray	Two years
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

Collaborators and Investigators

• Sponsor: Svante Berg
• Collaborators: Yara Asterfjord
• Investigators: Study Director: Svante Berg, MD, PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2018
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: September 2, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (Actual): September 17, 2018

Study Record Updates

• Last Update Posted (Actual): December 16, 2020
• Last Update Submitted That Met QC Criteria: December 12, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Intervertebral Disc Degeneration; Spinal Diseases
• Other Study ID Numbers: MollyMoa

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No