Clinical trial NCT03948542: Fractures of the Humeral Shaft With Primary Radial Nerve Palsy
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radial Nerve Palsy
Functional Outcome
Keywords: Intramedullary nailing
ORIF
Humeral shaft fracture
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2019-05-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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

Eligibility criteria: 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

Primary outcomes:
measure: Changes in nerve recovery; Nerve recovery after humeral shaft fracture and surgical treatment, Functional assessment
timeFrame: through study completion, from date of inclusion till first documented changes in nerve recovery, from date of admission assessed up to 36 months
Secondary outcomes:
measure: 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.
timeFrame: 2 weeks, 4 months
measure: Radiographic examination via X-ray in two planes
timeFrame: 3, 6 and 12 months after trauma
Other outcomes:
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