Fractures of the Humeral Shaft With Primary Radial Nerve Palsy

Fractures of the Humeral Shaft With Primary Radial Nerve Palsy: Do Injury Mechanism, Fracture Type, or Treatment Influence Nerve Recovery: A Retrospective Study

This study addresses the question if patients with fractures of the humeral shaft and primary radial nerve palsy gain nerve recovery.

Additionally the influence of injury mechanism, fracture type, and treatment modality on nerve recovery should be evaluated.

Study Overview

• Status: Completed
• Conditions: Radial Nerve Palsy; Functional Outcome
• Intervention / Treatment: Other: Outcome

Detailed Description

Adult fractures of the humeral shaft account for approximately 3% of all fractures; most can be treated nonoperatively. Due to the anatomy of the radial nerve and the entrapment between fragments in spiral fractures of the humerus, these injuries are associated with primary radial nerve palsy in up to 18%.

Therefore, the purpose of this study was to assess the influence of injury mechanism, fracture type, and type of surgical treatment on time to onset of nerve recovery and time to full nerve recovery in patients with humeral shaft fractures and concomitant primary radial nerve palsy.

A retrospective analysis of prospectively collected data for all patients treated with humeral shaft fracture and primary radial nerve palsy at an academic Level-I trauma center was performed. Between 1994 and 2013 a total of 615 patients with traumatic humeral shaft fractures were treated at the department. The dataset was examined for completeness and accuracy. Patients with an incomplete dataset, those with a pathologic or periprosthetic fracture, patients with non-surgical treatment, or who were younger than 18 years of age were excluded from this series. According to these criteria, a total of 50 patients with a humeral shaft fracture and primary radial nerve underwent surgical treatment

• Study Type: Observational
• Enrollment (Actual): 50

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study population will include patients treated with humeral shaft fracture and primary radial nerve palsy between 1994 and 2013 at the Department of Trauma Surgery, Medical University of Vienna

Description

Inclusion Criteria:

• patients treated with humeral shaft fracture and primary radial nerve palsy between 1994 and 2013 at the Department of Trauma Surgery, Medical University of Vienna
• surgical treatment
• complete data sets
• minimum 18 years of age

Exclusion Criteria:

• Patients with an incomplete dataset
• those with a pathologic or periprosthetic fracture
• patients with non-surgical treatment
• or who were younger than 18 years of age

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Outcome; Nerve conduction studies (NCV) Functional assessment according to Daniels and Worthingham	Other: Outcome; Nerve Recovery; NCV; Funcional assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in nerve recovery; Nerve recovery after humeral shaft fracture and surgical treatment, Functional assessment	Functional assessment was routinely performed at all follow up visits including a clinical evaluation and muscle strength (M0-M5) with a manual muscle test that was graded according to Daniels and Worthingham.	through study completion, from date of inclusion till first documented changes in nerve recovery, from date of admission assessed up to 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nerve conduction studies (NCV) were performed routinely at two weeks following onset of radial nerve palsy and after 4 months in case of delayed recovery.	Nerve conduction studies	2 weeks, 4 months
Radiographic examination via X-ray in two planes	X-ray in two planes	3, 6 and 12 months after trauma

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2014
• Primary Completion (ACTUAL): January 1, 2015
• Study Completion (ACTUAL): March 1, 2015

Study Registration Dates

• First Submitted: March 19, 2019
• First Submitted That Met QC Criteria: May 10, 2019
• First Posted (ACTUAL): May 14, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 17, 2019
• Last Update Submitted That Met QC Criteria: May 15, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: ORIF; Intramedullary nailing; Humeral shaft fracture
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Paralysis; Radial Neuropathy
• Other Study ID Numbers: F.o.t.H. Version 1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be available on request from the corresponding author in a blinded version

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No