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A Comparative Study Between Mechanical and a Viscoelastic Disc Prosthesis in the Lumbar Spine

NCT03716947 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2020-12-16

No results posted yet for this study

Summary

TDR implants for the lumbar spine are currently most 2- or 3-piece devices with a purely mechanical function that provide/restore mobility. Lately interest is growing on non-mechanical implants that could possibly provide/restore mobility, but also produce counterforces on mobility as in healthy discs. No previous comparison between these two concepts has been performed, neither on clinical outcome, neither on specific differences on facet-joint load and wear.

Conditions

  • Degenerative Disc Disease
  • Discogenic Low Back Pain

Interventions

PROCEDURE

Device: ZACK

Surgical procedure with total disc replacement using ZACK disc prostheses

PROCEDURE

Device: ORBIT

Surgical procedure with total disc replacement using ORBIT disc prostheses

PROCEDURE

Device: SASCA

Surgical procedure with anterior intracorporal fusion (ALIF) combined with adjacent level total disc replacement (TDR) (using either ORBIT mechanical disc prosthesis or ZACK viscoelastic disc prosthesis)

Sponsors & Collaborators

Principal Investigators

  • Svante Berg, MD,PhD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2022-08-01
Completion
2022-12-31

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03716947 on ClinicalTrials.gov