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PMCF Study on the Safety and Performance of CESPACE 3D (CATALINA)

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Aesculap

Status

Completed

Conditions

Post-discectomy Syndrome
Spondylolisthesis
Post-traumatic Instabilities
Degenerative Instability

Study type

Observational

Funder types

Industry

Identifiers

NCT04477447
AAG-O-H-2004

Details and patient eligibility

About

Prospective, pure data collection of all CeSPACE 3D patients in selected centers (not interventional, multicenter)

Enrollment

101 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient is minimum 18 years old
  • Written informed consent for the documentation of clinical and radiological results
  • Patient's indication according to IFU
  • Patient is not pregnant

Exclusion criteria

• Patient is not willing or able to participate at the follow-up examination

Trial contacts and locations

2

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Central trial contact

Stefan Maenz, Dr.

Data sourced from clinicaltrials.gov

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