Fractures of the Humeral Shaft With Primary Radial Nerve Palsy

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT03948542
Collaborator
(none)
50
13.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Outcome

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 Design

Study Type:
Observational
Actual Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
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 :
Jan 1, 2014
Actual Primary Completion Date :
Jan 1, 2015
Actual Study Completion Date :
Mar 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Outcome

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

Other: Outcome
Nerve Recovery NCV Funcional assessment

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. Radiographic examination via X-ray in two planes [3, 6 and 12 months after trauma]

    X-ray in two planes

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Thomas Tiefenboeck, M.D., MSc, Principal Investigator, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT03948542
Other Study ID Numbers:
  • F.o.t.H. Version 1.0
First Posted:
May 14, 2019
Last Update Posted:
May 17, 2019
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Thomas Tiefenboeck, M.D., MSc, Principal Investigator, Medical University of Vienna
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 17, 2019