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.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00027820

Enrollment

Registered

2022-01-27

Start date

2022-06-27

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

S32.1 S32.7

Interventions

Group 1: Baseline assessments (=pre-operative assessments) o Inclusion/exclusion o Anamnesis o EQ-5D-5L and EQ-VAS o radiological exam Assessments intra-operative: o Documentation of intra-operative

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria: Patients will be excluded if any of the following criteria apply: 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).

Design outcomes

Primary

Measure	Time frame
Primary Endpoints: Efficiency and performance measured via: - patient satisfaction: EQ-5D-5L, EQ-VAS - clinical patient outcome	—

Secondary

Measure	Time frame
Secondary endpoints: - usbility - user satisfaction - Clinical outcome of the examination based on radiological control via X-Ray and/or CT (optional) Safety measured via: - Product Deficiency - Serious and non-serious adverse events adverse events (SAE)s Assessment of events, whether implant-related yes/no	—

Countries

Germany

Contacts

Public ContactThomas Vordemvenne

Evangelisches Klinikum Bethel Universitätsklinikum OWL der Universität Bielefeld Campus Bielefeld-Bethel Klinik für Unfallchirurgie und Orthopädie

thomas.vordemvenne@evkb.de0521/772 77418

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026