Fractures of the Humeral Shaft With Primary Radial Nerve Palsy

NCT03948542 | Completed

• 1 other identifier: F.o.t.H. Version 1.0
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Radial Nerve Palsy; Functional Outcome

Keywords

Intramedullary nailing; ORIF; Humeral shaft fracture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• Radiographic examination via X-ray in two planes

  3, 6 and 12 months after trauma

Study Arms (1)

Outcome

Nerve conduction studies (NCV) Functional assessment according to Daniels and Worthingham

Other: Outcome

Interventions

Outcome OTHER

Nerve Recovery * NCV * Funcional assessment

Outcome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

MeSH Terms

Conditions

Radial Neuropathy

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: May 14, 2019
• Study Start: January 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: March 1, 2015
• Last Updated: May 17, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share