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NCT Number: NCT05256849

Treatment of Humeral Fractures With Long PHILOS Plates Using a Modified Technique and Approach Avoids Radial Nerve Palsy

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel, Orthopedics and Traumatology

Basel, 4031, Switzerland

About this study

Radial paralysis is a well-known complication of plate osteosynthesis on the humeral shaft. With regard to surgical treatment, there are major differences in terms of surgical access and implant selection. At the University Hospital Basel, these fractures have been treated in an adapted procedure for about 10 years. A long Philosplatte (Synthes company) is inserted from the proximal end via a deltoido-pectoral approach. This is a minimally invasive procedure (MIPO = minimally invasive plate osteosynthesis). The standard implant is first twisted distally by approx. 45°-90° and then lies anterior to the humerus. The distal screws can then be filled via anterior stab incisions. This adapted surgical technique is adapted to the anatomical course of the radial nerve. This ensures a safe distance from the plate/access to the nerve. The nerve does not have to be explored openly and the distal row of screws can be used minimally invasively via stab incisions. This study is to retrospectively analyze the effectiveness of the surgical technique in relation to iatrogenic radial paralysis.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients with a documented rejection

Treatment and study plan

Primary outcomes

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

    Time frame: one time assessment at baseline

    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)

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Feb 25, 2022
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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