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

NCT03674190 | Withdrawn

• 1 other identifier: MollyMoa
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Disc Disease Degenerative; Disk Degeneration; Disc Disease Lumbar

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• VAS, Visual Analogue Scale

  Two years

• Segment Mobility

  Two years

• Patient reported back pain after two years in Swespine national registry

  Two years

Study Arms (2)

Anterior Lumbar Interbody Fusion

EXPERIMENTAL

Surgical treatment Anterior Lumbar Interbody Fusion

Procedure: Anterior Lumbar Interbody Fusion

Total disc replacement

ACTIVE COMPARATOR

Surgical treatment total disc replacement in the lumbar spine

Procedure: Total Disc Replacement

Interventions

Anterior Lumbar Interbody Fusion PROCEDURE

Anterior Lumbar Fusion(ALIF)

Anterior Lumbar Interbody Fusion

Total Disc Replacement PROCEDURE

Total Disc Replacement

Total disc replacement

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Svante Berg: lead
• Yara Asterfjord: collaborator

Study Sites (1)

Spine Center Göteborg

Gothenburg, SE-42130, Sweden

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Intervertebral disc disease

Interventions

Total Disc Replacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Svante Berg, MD, PhD

  Karolinska Institutet

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 2, 2018
• First Posted: September 17, 2018
• Study Start: September 4, 2018
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2022
• Last Updated: December 16, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)