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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05269719
Other study ID # Digital nerve injury, epi
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date June 1, 2021

Study information

Verified date February 2022
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a registry and medical record based epidemiological description of patients with digitial nerve injuies in the Stockholm County, Sweden


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.


Recruitment information / eligibility

Status Completed
Enrollment 1004
Est. completion date June 1, 2021
Est. primary completion date June 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Suture of digital nerve
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.

Locations

Country Name City State
Sweden Karolinska Institutet Södersjukhuset, Department of clinical research and education Stockholm

Sponsors (2)

Lead Sponsor Collaborator
Karolinska Institutet Region Stockholm

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence The incidence of digital nerve injury as calculated as the numbers of treated patients divided by the population at risk at study inclusion
Secondary 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. at study inclusion
Secondary 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 through study completion, at an average 6 months
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