NCT05256849

Brief Summary

Radial paralysis is a well-known complication of plate osteosynthesis on the humeral shaft. At the University Hospital Basel, these fractures have been treated in an adapted procedure with long PHILOS plates using a modified technique and approach. This study is to retrospectively analyze the effectiveness of the surgical technique in relation to iatrogenic radial paralysis.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 16, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 25, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 7, 2025

Status Verified

February 1, 2025

Enrollment Period

3 years

First QC Date

February 16, 2022

Last Update Submit

February 4, 2025

Conditions

Humeral Fracture

Keywords

PHILOS plateminimal invasive plate osteosynthesis (MIPO)radial paralysis

Outcome Measures

Primary Outcomes (1)

  • descriptive statistical analysis of datasets from patients treated with the adapted surgical technique

    datasets from patients (information about hospitalizations and risk factors, traumatological and orthopedic information (precise diagnosis and classification, date, number and type of operation, complications), infectious data (detection of germs, type and duration of therapy)

    one time assessment at baseline

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients aged 18 and over who underwent surgery at the University Hospital Basel between 06/2010 and 12/2020 for a proximal humeral shaft fracture

You may qualify if:

  • surgery at the University Hospital Basel between 06/2010 and 12/2020 for a proximal humeral shaft fracture

You may not qualify if:

  • Patients with a documented rejection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel, Orthopedics and Traumatology

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Humeral FracturesParalysis

Condition Hierarchy (Ancestors)

Arm InjuriesWounds and InjuriesFractures, BoneNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Daniel Rikli, Prof. Dr. med.

    University Hospital Basel, Clinic for Orthopedics and Traumatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2022

First Posted

February 25, 2022

Study Start

January 6, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

February 7, 2025

Record last verified: 2025-02

Locations

CH(1)