Traumatic InjuryNCT04980937
Peroneal Nerve Injury: a 20- Year Retrospective Case Series Study
An observational study of Traumatic Injury and Peroneal Nerve Injury, run by Medical University Innsbruck.
Trial summary
In a 20-year retrospective study, all skiers and snowboarders with a peroneal nerve injury at the fibular head treated surgically at the Department of Plastic, Reconstructive and Aesthetic Surgery at the Medical University of Innsbruck, Austria, were included. Covering a period from 1999/2000 to 2018/2019. Read more about this study
- Who is it for?
- Ages 10 to 64 years
- Conditions the study is for
- Traumatic Injury, Peroneal Nerve Injury, Sport Injury
- What is being tested?
- Microsurgical reconstruction of peroneal nerve with or w/o nerve grafts.
- Type of treatment
- Surgery or procedure
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 1999to 31 Dec 2019
- 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 10 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All patients who suffered a peroneal nerve injury caused by the sharp edge of a ski or snowboard and required surgical intervention.
Who may be able to join
- Skiers and snowboarders
- treated with a peroneal nerve injury at the fibular head
- time frame January 1999 to Dicember 2019
Who cannot join
- Different injury mechanism
- injury of a different nerve than peroneal nerve
About this study
Official title: Ski- and Snowboard Related Open Peroneal Nerve Injury: a 20- Year Retrospective Case Series Study
In a 20-year retrospective study, all skiers and snowboarders with a peroneal nerve injury at the fibular head treated surgically at the Department of Plastic, Reconstructive and Aesthetic Surgery at the Medical University of Innsbruck, Austria, were included. Covering a period from 1999/2000 to 2018/2019.
Read the detailed description
All data were gained in a clinical routine context, and the study design was retrospective. The work was approved by the local ethics committee of the Medical University of Innsbruck, Innsbruck, Austria (EK Nr.: 1300/2019). We reviewed medical charts from over a 20-year period, including all patients with a PNI after a ski- or snowboard-related accident requiring surgical intervention at the Department of Plastic, Reconstructive and Aesthetic Surgery of the Medical University of Innsbruck, Austria.
We analyzed the demographical data, including age, gender, and citizenship, as well as included variables concerning the winter sport activity (i.e., ski or snowboard, owned or rented, self-inflicted without collision or collision caused by another skier or snowboarder, professional or recreational athlete). We also analyzed the injury itself (i.e., PNI as main injury, open or closed, motoric, sensible or both, fracture, muscle injury, complete or incomplete transection), as well as the treatment.
- Conditions
- Traumatic Injury, Peroneal Nerve Injury, Sport Injury
- Being tested
- Microsurgical reconstruction of peroneal nerve with or w/o nerve grafts.
- Keywords
- Ski accident, traumatic, peroneal nerve injury, reconstructive surgery, case series
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microsurgical reconstruction of peroneal nerve with or w/o nerve grafts.Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients with perineal nerve damage after ski injury | Retrospectively aquired patients from insight in medical records. All patients with perineal nerve damage after ski injury in the time period of question were enrolled. Inclusion required operative management of the injury interns of microsurgical reconstruction of peroneal nerve. Receives: Procedure: Microsurgical reconstruction of peroneal nerve with or w/o nerve grafts. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful nerve reconstruction
Functional reconstruction (Janda degree >3; 2-point discrimination)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start1 Jan 1999
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic InjuryStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04980937
- Sponsor's protocol ID
- IBK-peroneus_2020
- Status last verified
- Apr 2021
- First submitted
- 22 Apr 2021
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ski- and Snowboard Related Open Peroneal Nerve Injury: a 20- Year Retrospective Case Series Study
- ClinicalTrials.gov ID
- NCT04980937
- Acronym / sponsor ID
- IBK-peroneus_2020
- Conditions
- Traumatic Injury, Peroneal Nerve Injury, Sport Injury
- Keywords
- Ski accident, traumatic, peroneal nerve injury, reconstructive surgery, case series
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 1 Jan 1999 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 28 Jul 2021 (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.
In a 20-year retrospective study, all skiers and snowboarders with a peroneal nerve injury at the fibular head treated surgically at the Department of Plastic, Reconstructive and Aesthetic Surgery at the Medical University of Innsbruck, Austria, were included. Covering a period from 1999/2000 to 2018/2019.
Detailed description
All data were gained in a clinical routine context, and the study design was retrospective. The work was approved by the local ethics committee of the Medical University of Innsbruck, Innsbruck, Austria (EK Nr.: 1300/2019). We reviewed medical charts from over a 20-year period, including all patients with a PNI after a ski- or snowboard-related accident requiring surgical intervention at the Department of Plastic, Reconstructive and Aesthetic Surgery of the Medical University of Innsbruck, Austria.
We analyzed the demographical data, including age, gender, and citizenship, as well as included variables concerning the winter sport activity (i.e., ski or snowboard, owned or rented, self-inflicted without collision or collision caused by another skier or snowboarder, professional or recreational athlete). We also analyzed the injury itself (i.e., PNI as main injury, open or closed, motoric, sensible or both, fracture, muscle injury, complete or incomplete transection), as well as the treatment.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with perineal nerve damage after ski injury | – | Procedure: Microsurgical reconstruction of peroneal nerve with or w/o nerve grafts.Retrospectively aquired patients from insight in medical records. All patients with perineal nerve damage after ski injury in the time period of question were enrolled. Inclusion required operative management of the injury interns of microsurgical reconstruction of peroneal nerve. |
Who may qualify
- Ages
- 10 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All patients who suffered a peroneal nerve injury caused by the sharp edge of a ski or snowboard and required surgical intervention.
Key inclusion criteria (3 listed)
- Skiers and snowboarders
- treated with a peroneal nerve injury at the fibular head
- time frame January 1999 to Dicember 2019
Key exclusion criteria (2 listed)
- Different injury mechanism
- injury of a different nerve than peroneal nerve
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 |
|---|---|---|
| Microsurgical reconstruction of peroneal nerve with or w/o nerve grafts. | Procedure or surgery | Patients with perineal nerve damage after ski injury |
Primary outcome
Successful nerve reconstruction
Time frame: 1 year
Functional reconstruction (Janda degree >3; 2-point discrimination)
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 28 Jul 2021.
- Individual participant dataSharing planned: No
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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 Traumatic Injury and Peroneal Nerve Injury, run by Medical University Innsbruck.
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 3 inclusion and 2 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 28 Jul 2021. 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?
Successful nerve reconstruction (time frame: 1 year). 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 28 Jul 2021.