UnknownNot Applicable

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

Sweden246 participantsStarted 2018-02-01

Plain-language 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.

Who can participate

Age range20 Years – 55 Years

SexALL

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Inclusion criteria

✓Patient between 20 and 55 years of age. -
✓Patient able to understand written and spoken Swedish.

Exclusion criteria

✕Patient residing outside Sweden and thus is not covered with SweSpine. -

What they're measuring

Patient reported back pain after two years in Swespine national registry

Timeframe: 2, 5, 10 years

Trial details

NCT IDNCT03716947

SponsorKarolinska Institutet

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-01

View on ClinicalTrials.gov More Degenerative Disc Disease trials