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Clinical Trials/DRKS00027820
DRKS00027820RecruitingNot Applicable

A multi center, open, pro- and retrospective, non-controlled observational trial to evaluate the intra-operative instrumentation procedure for the stabilization of symptomatic instabilities of the posterior pelvic ring, iliosacral or lumbar-pelvic region. - PMCF Study Triangular Fixation

Silony Medical GmbH0 sites42 target enrollmentStarted: January 27, 2022Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
42
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18 Years to one (—)
Sex
All

Inclusion Criteria

  • •The VERTICALE Triangular Fixation System can be used to manage the following indications of the thoracic, thoracolumbar and lumbar spine:
  • •1. Skeletally mature patients (=18years) with symptomatic instabilities of the posterior pelvic ring, iliosacral or lumbar-pelvic region
  • •2. Willing to sign patient consent form (except for survey patients)
  • •3. Patients fulfilling the inclusion and exclusion criteria in regards to indications.

Exclusion Criteria

  • •Patients will be excluded if any of the following criteria
  • •1. Expected or documented allergy or intolerance against materials (eg. titan or polyethylen).
  • •2. Any case where the chosen implants would be too big or too small to achieve a successful result
  • •3. Any patient using the implant would be in conflict with their anatomic structure
  • •4. Missing bony structures necessary for a safe anchoring of the implant (eg. with fractures, tumour or osteoporosis).

Investigators

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