NCT05269719

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,004

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 8, 2022

Completed
Last Updated

March 8, 2022

Status Verified

February 1, 2022

Enrollment Period

5 months

First QC Date

October 7, 2021

Last Update Submit

February 25, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Demographic features of the patient cohort

    at study inclusion

  • Health care interventions

    through study completion, at an average 6 months

Study Arms (2)

Digital nerve injury, surgical treatment, isolated injury

Patient over the age of 18 with an isolated injury to a digital nerve.

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.

Procedure: Suture of digital nerve

Interventions

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.

Digital nerve injury, surgical treatment, concomittant flexor tendon injuryDigital nerve injury, surgical treatment, isolated injury

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet Södersjukhuset, Department of clinical research and education

Stockholm, 11883, Sweden

Location

Study Officials

  • Marianne Arner, Professor

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 7, 2021

First Posted

March 8, 2022

Study Start

January 1, 2021

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

March 8, 2022

Record last verified: 2022-02

Locations