Digital Nerve InjuryNCT05269719
Epidemiology of Digital Nerve Injuries in the Stockholm County
An observational study of Digital Nerve Injury, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
This is a registry and medical record based epidemiological description of patients with digitial nerve injuies in the Stockholm County, Sweden Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Digital Nerve Injury
- What is being tested?
- Suture of digital nerve
- Type of treatment
- Surgery or procedure
- How many people
- 1,004 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2021to 1 Jun 2021
- 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: All patients treated with surgical repair of a operatively for a digital nerve injury at the Department of Hand Surgery at Södersjukhuset, Stockholm, Sweden between 2012-01-01 and 2018-12-31 were included.
Who may be able to join
- diagnostic codes (ICD-10) for a digital nerve injury in the thumb (S64.3) or finger (S64.4) in combination with the surgical code (KKÅ97) Nomesco classification of surgical procedures for nerve repair (ACB29).
Who cannot join
- concomitant skeletal injury
- amputations
- severe soft tissue injuries
- injury needed microvascular reconstruction.
- Patients reciding outside the Stockholm region and
- patient age below 18 years of age
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Institutet Södersjukhuset, Department of clinical research and education
Stockholm, 11883
About this study
This is a registry and medical record based epidemiological description of patients with digitial nerve injuies in the Stockholm County, Sweden
Read the detailed description
The primary aim of this study was to describe the epidemiology of patients with surgically repaired digital nerve injuries in a Swedish population during the period 2012 to 2018. Secondary aims included a description of the patient population, surgical treatment and rehabilitation regimens following digital nerve injury. Comparisons were made between groups consisting in patients with isolated nerve injuries and those with a concomitant flexor tendon injury.
METHODS
Patients In this cohort study, all patients treated with surgical repair of a digital nerve injury at the Department of Hand Surgery at Södersjukhuset, Stockholm, Sweden were included. Inclusion period was between 2012-01-01 and 2018-12-31. Patients were identified through the Swedish national quality registry for Hand surgery (HAKIR). Inclusion criteria were the diagnostic codes (ICD-10) for a digital nerve injury in the thumb (S64.3) or finger (S64.4) in combination with the surgical code (KKÅ97) Nomesco classification of surgical procedures for nerve repair (ACB29). A total of 1,329 patients were identified. Exclusion criteria were concomitant skeletal injury, amputations, severe soft tissue injuries, or if the injury needed microvascular reconstruction. Patients reciding outside the Stockholm region and children below 18 years of age were also excluded. A total of 1,004 patients were included for the final analysis. The study population was thereafter divided into two groups: patients with an isolated digital nerve injury and patients with a ditial nerve injry with a concomitant tendon injury. All clinical data was collected through search of medical records.
- Conditions
- Digital Nerve Injury
- Being tested
- Suture of digital nerve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suture of digital nerveProcedure or surgery
The digital nerves were sutured according to the discretion of the treating surgeon and the standard procedure was three epineural sutures 8.0 or 9.0 nylon under loop magnification. Concomitant tendon injuries were also sutured according to the discretion of the treating surgeon, most commonly with two loop sutures (four strand core) and a peritendinous PDS suture.
| Study group | Role | What they receive |
|---|---|---|
| Digital nerve injury, surgical treatment, isolated injury | Patient over the age of 18 with an isolated injury to a digital nerve. Receives: Procedure: Suture of digital nerve | |
| Digital nerve injury, surgical treatment, concomittant flexor tendon injury | Patient over the age of 18 with an injury to a digital nerve and a concomittant flexor tendon injury. Receives: Procedure: Suture of digital nerve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence
The incidence of digital nerve injury as calculated as the numbers of treated patients divided by the population at risk
Measured: at study inclusion
Secondary outcomes (2)
Demographic features of the patient cohort
date of birth, gender, injured hand, time and date of injury and surgery. Injured nerve, injury level, injury mechanism and type of injury, total or partial nerve injury, isolated nerve injury/concomitant flexor tendon injury, and postoperative complications. Smoking status, profession, numbres of visits to health care professionals.
Measured: at study inclusion
Health care interventions
time from injury to surgery, time from injury to rehabilitation, types of rehabilitation, number of visits to health care personnel, days of sick leave
Measured: through study completion, at an average 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start1 Jan 2021
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digital Nerve InjuryStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Cross-sectional
- Enrolment
- 1,004 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Cecilia Mellstrand Navarro, Karolinska Institutet
- Investigators
- Marianne Arner, Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269719
- Sponsor's protocol ID
- Digital nerve injury, epi
- Status last verified
- Feb 2022
- First submitted
- 7 Oct 2021
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Digital Nerve Injuries in the Stockholm County
- ClinicalTrials.gov ID
- NCT05269719
- Acronym / sponsor ID
- Digital nerve injury, epi
- Conditions
- Digital Nerve Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,004 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 8 Mar 2022 (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 is a registry and medical record based epidemiological description of patients with digitial nerve injuies in the Stockholm County, Sweden
Detailed description
The primary aim of this study was to describe the epidemiology of patients with surgically repaired digital nerve injuries in a Swedish population during the period 2012 to 2018. Secondary aims included a description of the patient population, surgical treatment and rehabilitation regimens following digital nerve injury. Comparisons were made between groups consisting in patients with isolated nerve injuries and those with a concomitant flexor tendon injury.
METHODS
Patients In this cohort study, all patients treated with surgical repair of a digital nerve injury at the Department of Hand Surgery at Södersjukhuset, Stockholm, Sweden were included. Inclusion period was between 2012-01-01 and 2018-12-31. Patients were identified through the Swedish national quality registry for Hand surgery (HAKIR). Inclusion criteria were the diagnostic codes (ICD-10) for a digital nerve injury in the thumb (S64.3) or finger (S64.4) in combination with the surgical code (KKÅ97) Nomesco classification of surgical procedures for nerve repair (ACB29). A total of 1,329 patients were identified. Exclusion criteria were concomitant skeletal injury, amputations, severe soft tissue injuries, or if the injury needed microvascular reconstruction. Patients reciding outside the Stockholm region and children below 18 years of age were also excluded. A total of 1,004 patients were included for the final analysis. The study population was thereafter divided into two groups: patients with an isolated digital nerve injury and patients with a ditial nerve injry with a concomitant tendon injury. All clinical data was collected through search of medical records.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital nerve injury, surgical treatment, isolated injury | – | Procedure: Suture of digital nervePatient over the age of 18 with an isolated injury to a digital nerve. |
| Digital nerve injury, surgical treatment, concomittant flexor tendon injury | – | Procedure: Suture of digital nervePatient over the age of 18 with an injury to a digital nerve and a concomittant flexor tendon injury. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients treated with surgical repair of a operatively for a digital nerve injury at the Department of Hand Surgery at Södersjukhuset, Stockholm, Sweden between 2012-01-01 and 2018-12-31 were included.
Key inclusion criteria (1 listed)
- diagnostic codes (ICD-10) for a digital nerve injury in the thumb (S64.3) or finger (S64.4) in combination with the surgical code (KKÅ97) Nomesco classification of surgical procedures for nerve repair (ACB29).
Key exclusion criteria (6 listed)
- concomitant skeletal injury
- amputations
- severe soft tissue injuries
- injury needed microvascular reconstruction.
- Patients reciding outside the Stockholm region and
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 |
|---|---|---|
| Suture of digital nerveThe digital nerves were sutured according to the discretion of the treating surgeon and the standard procedure was three epineural sutures 8.0 or 9.0 nylon under loop magnification. Concomitant tendon injuries were also sutured according to the discretion of the treating surgeon, most commonly with two loop sutures (four strand core) and a peritendinous PDS suture. | Procedure or surgery | Digital nerve injury, surgical treatment, concomittant flexor tendon injury, Digital nerve injury, surgical treatment, isolated injury |
Primary outcome
Incidence
Time frame: at study inclusion
The incidence of digital nerve injury as calculated as the numbers of treated patients divided by the population at risk
2 secondary outcomes
Demographic features of the patient cohort
Time frame: at study inclusion
Health care interventions
Time frame: through study completion, at an average 6 months
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 8 Mar 2022.
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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.
Marianne Arner, Professor principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Digital Nerve Injury, run by Karolinska Institutet at 1 site in Sweden.
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 1 inclusion and 6 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 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Incidence (time frame: at study inclusion). 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 8 Mar 2022.