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

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Recruiting
CT.gov ID
NCT05256849
Collaborator
(none)
80
1
10.8
7.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Treatment of Humeral Fractures With Long PHILOS Plates Using a Modified Technique and Approach Avoids Radial Nerve Palsy
    Actual Study Start Date :
    Jan 6, 2022
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2022

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Basel, Orthopedics and Traumatology Basel Switzerland 4031

    Sponsors and Collaborators

    • University Hospital, Basel, Switzerland

    Investigators

    • Principal Investigator: Daniel Rikli, Prof. Dr. med., University Hospital Basel, Clinic for Orthopedics and Traumatology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Basel, Switzerland
    ClinicalTrials.gov Identifier:
    NCT05256849
    Other Study ID Numbers:
    • 2021-01959; mu22Rikli
    First Posted:
    Feb 25, 2022
    Last Update Posted:
    Feb 25, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Basel, Switzerland
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 25, 2022