- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05269719
Epidemiology of Digital Nerve Injuries in the Stockholm County
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Stockholm, Sweden, 11883
- Karolinska Institutet Södersjukhuset, Department of clinical research and education
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Digital nerve injury, surgical treatment, isolated injury
Patient over the age of 18 with an isolated injury to a digital nerve.
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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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence
Time Frame: at study inclusion
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The incidence of digital nerve injury as calculated as the numbers of treated patients divided by the population at risk
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at study inclusion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Demographic features of the patient cohort
Time Frame: at study inclusion
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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.
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at study inclusion
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Health care interventions
Time Frame: through study completion, at an average 6 months
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time from injury to surgery, time from injury to rehabilitation, types of rehabilitation, number of visits to health care personnel, days of sick leave
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through study completion, at an average 6 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Marianne Arner, Professor, Karolinska Institutet
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Digital nerve injury, epi
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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