Radial Nerve PalsyNCT03948542
Fractures of the Humeral Shaft With Primary Radial Nerve Palsy
An observational study of Radial Nerve Palsy and Functional Outcome, run by Medical University of Vienna.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radial Nerve Palsy, Functional Outcome
- What is being tested?
- Outcome
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 1 Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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.
Read the 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
- Conditions
- Radial Nerve Palsy, Functional Outcome
- Being tested
- Outcome
- Keywords
- Intramedullary nailing, ORIF, Humeral shaft fracture
- Medical subject headings
- Radial Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OutcomeOther
Nerve Recovery
- NCV
- Funcional assessment
| Study group | Role | What they receive |
|---|---|---|
| Outcome | Nerve conduction studies (NCV) Functional assessment according to Daniels and Worthingham Receives: Other: Outcome |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Nerve conduction studies
Measured: 2 weeks, 4 months
Radiographic examination via X-ray in two planes
X-ray in two planes
Measured: 3, 6 and 12 months after trauma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start1 Jan 2014
- Primary completion1 Jan 2015
- Study completion1 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radial Nerve PalsyStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Tiefenboeck, M.D., MSc, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948542
- Sponsor's protocol ID
- F.o.t.H. Version 1.0
- Status last verified
- May 2019
- First submitted
- 19 Mar 2019
- Last updated
- 17 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available on request from the corresponding author in a blinded version
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03948542
- Acronym / sponsor ID
- F.o.t.H. Version 1.0
- Conditions
- Radial Nerve Palsy, Functional Outcome
- Keywords
- Intramedullary nailing, ORIF, Humeral shaft fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Jan 2015 (actual)
- Study completion
- 1 Mar 2015 (actual)
- First posted
- 14 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Outcome | – | Other: OutcomeNerve conduction studies (NCV) Functional assessment according to Daniels and Worthingham |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OutcomeNerve Recovery * NCV * Funcional assessment | Other | Outcome |
Primary outcome
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.
2 secondary outcomes
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
Radiographic examination via X-ray in two planes
Time frame: 3, 6 and 12 months after trauma
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2019.
- Individual participant dataSharing planned: No. Data will be available on request from the corresponding author in a blinded version
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Radial Nerve Palsy and Functional Outcome, run by Medical University of Vienna.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2019.