Fractures of the Humeral Shaft With Primary Radial Nerve Palsy

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.

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Key information

Conditions

Radial Nerve Palsy Functional Outcome Mononeuropathies Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Radial Neuropathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Outcome

Other

Nerve Recovery

NCV
Funcional assessment

Primary outcomes

Changes in nerve recovery; Nerve recovery after humeral shaft fracture and surgical treatment, Functional assessment

Time frame: 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 outcomes

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.

Time frame: 2 weeks, 4 months

Nerve conduction studies
Radiographic examination via X-ray in two planes

Time frame: 3, 6 and 12 months after trauma

X-ray in two planes

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: May 14, 2019
Registry last updated: May 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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