Fractures of the Humeral Shaft With Primary Radial Nerve Palsy

Functional Outcome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03948542
• Other study ID #: F.o.t.H. Version 1.0
• Status: Completed
• Start date: January 1, 2014
• Est. completion date: March 1, 2015

Study information

• Verified date: May 2019
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 1, 2015
• Est. primary completion date: January 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Functional Outcome
• Paralysis
• Radial Nerve Palsy
• Radial Neuropathy

Intervention

Other:
• Outcome
Nerve Recovery NCV Funcional assessment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Radiographic examination via X-ray in two planes	X-ray in two planes	3, 6 and 12 months after trauma