Fractures of the Humeral Shaft With Primary Radial Nerve Palsy
|ClinicalTrials.gov Identifier: NCT03948542|
Recruitment Status : Completed
First Posted : May 14, 2019
Last Update Posted : May 17, 2019
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.
|Condition or disease||Intervention/treatment|
|Radial Nerve Palsy Functional Outcome||Other: Outcome|
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|
|Actual Enrollment :||50 participants|
|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|
|Actual Study Start Date :||January 1, 2014|
|Actual Primary Completion Date :||January 1, 2015|
|Actual Study Completion Date :||March 1, 2015|
Nerve conduction studies (NCV) Functional assessment according to Daniels and Worthingham
- 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.
- 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