NEXPECT – Multicenter post-market observational study Nexos Pelvis - Pelvic Fixation System

NEXPECT – Multicenter post-market observational study Nexos Pelvis - Pelvic Fixation System - NEXPECT

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00037395

Enrollment

146

Registered

2025-07-11

Start date

2026-01-20

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

S32

Interventions

Group 1: Nexos Pelvis - Pelvic Fixation System

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Patient is undergoing surgery using the Pelvic Fixation System - Written informed consent obtained for the treatment - Treatment of pelvic and/or acetabular fractures - Treatment of acute and chronic conditions and instabilities in the pelvis and/or acetabulum where there is a clinical need for osteosynthesis. - Oncological diseases whose treatment requires an intervention (osteosynthetic stabilisation) in the pelvic region e.g. osteolytic metastases.

Exclusion criteria

Exclusion criteria: - Patients matching any contraindication as stated in the IFU - Patients with mental disorders such as dementia and bedridden patients - Recent history of substance abuse (i.e., recreational drugs, alcohol) that would preclude reliable assessment - Pregnancy or women planning to conceive within the study period - Persons who are legally detained in an official institution - Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study - Intraoperative decision to use implants other than the device under investigation

Design outcomes

Primary

Measure	Time frame
The primary objective of this PMCF study is to assess implant function within a follow-up of 6 months after the application of the Pelvic Fixation System. The implant function is defined by the modified Merle d’Aubigné score.	—

Secondary

Measure	Time frame
Secondary objectives are to assess implant survival and collect clinical data on intraoperative complications, including problems with the handling of the implants and instruments used. In addition, the rate of complications within the first 6 months after surgery will be evaluated.	—

Countries

Germany

Contacts

Public ContactUlrich Stöckle

Charité Berlin, Centrum für Muskuloskeletale Chirurgie

ulrich.stoeckle@charite.de+49 (0)30 450 552 012

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026