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Fractures of the Humeral Shaft With Primary Radial Nerve Palsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03948542
Recruitment Status : Completed
First Posted : May 14, 2019
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Tiefenboeck, M.D., MSc, 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.


Condition or disease Intervention/treatment
Radial Nerve Palsy Functional Outcome 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

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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 : January 1, 2014
Actual Primary Completion Date : January 1, 2015
Actual Study Completion Date : March 1, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures Paralysis

Group/Cohort Intervention/treatment
Outcome
Nerve conduction studies (NCV) Functional assessment according to Daniels and Worthingham
Other: Outcome

Nerve Recovery

  • NCV
  • Funcional assessment




Primary Outcome Measures :
  1. 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 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. [ Time Frame: 2 weeks, 4 months ]
    Nerve conduction studies

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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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
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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    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be available on request from the corresponding author in a blinded version

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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, Medical University of Vienna:
Intramedullary nailing
ORIF
Humeral shaft fracture
Additional relevant MeSH terms:
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Paralysis
Radial Neuropathy
Neurologic Manifestations
Nervous System Diseases
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases