Fractures of the Humeral Shaft With Primary Radial Nerve Palsy

Completed

• Conditions: Radial Nerve Palsy; Functional Outcome
• Interventions: Other: Outcome

• Registration Number: NCT03948542
• Lead Sponsor: Medical University of Vienna

Brief 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.

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 Timeline

• Study Start: 2014-01-01
• Primary Completion: 2015-01-01
• Study Completion: 2015-03-01
• Study First Submitted: 2019-03-19
• Status Verified: 2019-05
• Study First Submitted QC: 2019-05-10
• Study First Posted: 2019-05-14
• Last Update Submitted: 2019-05-15
• Last Update Posted: 2019-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Outcome	Outcome	Nerve conduction studies (NCV) Functional assessment according to Daniels and Worthingham

Primary Outcome Measures

Name	Time	Method
Changes in nerve recovery; Nerve recovery after humeral shaft fracture and surgical treatment, Functional assessment	through study completion, from date of inclusion till first documented changes in nerve recovery, from date of admission assessed up to 36 months	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.

Secondary Outcome Measures

Name	Time	Method
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.	2 weeks, 4 months	Nerve conduction studies
Radiographic examination via X-ray in two planes	3, 6 and 12 months after trauma	X-ray in two planes