Active — Not RecruitingNot Applicable

PMCF Neo Pedicle Screw and Cage Systems

Germany, Spain150 participantsStarted 2019-10-15

Plain-language summary

The objectives of this clinical observational study is to evaluate the safety and efficacy (performance) of the Neo Pedicle Screw System™ and the Neo Cage System™ interbody fusion device. To demonstrate non-inferiority of safety and function to an historical control from the published medical literature on competitive devices.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: * Patient has undergone or is intended to undergo surgery with the Neo Pedicle Screw System™, standalone or in combination with the Neo Cage System™, for any of the approved indications as defined in the respective labelling * Patient has participated in or is willing to participate in the routine postoperative follow-up program * Patient is willing to provide written informed consent Exclusion criteria: * Patient is under the age of 18 or skeletally immature * Patient had or has a contraindication to surgery or to any of the implant systems used in the study, as defined in the respective labelling

What they're measuring

Change in patient´s function from baseline to 12 months

Timeframe: 12 months

The rate of cage migration in cage-plus-screw systems.

Timeframe: 12 months and 24 months post operatively

The rate of pedicle screw loosening in screw only and cage-plus-screw systems.

Timeframe: 12 months and 24 months post operatively

Trial details

NCT IDNCT03956537

SponsorNeo Medical SA

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-01-31

View on ClinicalTrials.gov More Degenerative Disc Disease trials