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

Humeral Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05256849
• Other study ID #: 2021-01959; mu22Rikli
• Status: Recruiting
• Start date: January 6, 2022
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Daniel Rikli, Prof. Dr. med.
• Phone: +41 61 556 53 91
• Email: Daniel.Rikli[@]usb.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fracture
• Humeral Fractures
• Radial Neuropathy

Locations

Country	Name	City	State
Switzerland	University Hospital Basel, Orthopedics and Traumatology	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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