CompletedPhase 3

Study of Safety & Effectiveness of PRESTIGE® LP Cervical Disc vs. Anterior Cervical Fusion in Cervical DDD

United States280 participantsStarted 2005-01

Plain-language summary

The purpose of this clinical trial is to evaluate the safety and effectiveness of the PRESTIGE® LP Cervical Disc as a method of treating patients with symptoms of cervical degenerative disc disease at a single level from C3-C4 to C6-C7.

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. Sagittal plane translation \> 3.5mm or
✕. Sagittal plane angulation \> 20 degrees.
✕. Postmenopausal non-Black female over 60 years of age and weighs less than 140 pounds
✕. Postmenopausal female that has sustained a non-traumatic hip, spine, or wrist fracture
✕. Male over the age of 70
✕. Male over the age of 60 that has sustained a non-traumatic hip or spine fracture.

What they're measuring

Rate of Overall Success

Timeframe: 24 months

Trial details

NCT IDNCT00667459

SponsorMedtronic Spinal and Biologics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-01

Results submitted2014-08-22

View on ClinicalTrials.gov More Cervical Degenerative Disc Disease trials