NCT05337917

Brief Summary

Case control study, investigating what hand function and sensory function do patients perform 3-10 years following digital nerve injury and repair. The aim is to investigate if hand function is more limited following digital nerve injury in the thumb, index- and little finger, compared to less unburdened sensory surfaces in the fingers. Secondary aim is to investigate the long term sensory function following digital nerve injury.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 20, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

October 4, 2023

Status Verified

October 1, 2023

Enrollment Period

1.3 years

First QC Date

January 29, 2022

Last Update Submit

October 2, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Handfunction

    Measured by Mini Sollerman test for handfunction.

    3-10 years post operatively

Secondary Outcomes (11)

  • Sensation

    3-10 years post operatively

  • Sensation

    3-10 years post operatively

  • Patient Rated Outcome Measure (PROM) for hand function

    3-10 yrs post op

  • PROM for hand function

    3-10 yrs post op

  • PROM for hand function

    3-10 yrs post op

  • +6 more secondary outcomes

Study Arms (2)

Case

Injury to digital nerve: thumb, digit II radial side, digit V ulnar side

Procedure: Surgical of the digital nerve

Control

Injury to digital nerve: digit II ulnarside, dig III, dig IV dig V radial side.

Procedure: Surgical of the digital nerve

Interventions

All patients (cases and controls) were subject to surgical repair of digital nerve injury.

CaseControl

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants with digital nerve injury were identified from a registry cohort consisting in 1330 patients. They were all treated due to a digital nerve injury at our hospital 2012 - 2018. A random sample of cases and controls were selected, matched for time from injury to evaluation, age and sex.

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).
  • treatment completed in Södersjukhuset hospital 2012 - 2018

You may not qualify if:

  • concomitant skeletal injury,
  • amputations
  • severe soft tissue injuries
  • microvascular reconstruction
  • residence outside the Stockholm region
  • patient age below 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linda Evertsson

Stockholm, 11883, Sweden

Location

Study Officials

  • Cecilia Mellstrand Navarro, MD Prof

    Region Stockholm

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 29, 2022

First Posted

April 20, 2022

Study Start

September 1, 2021

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

October 4, 2023

Record last verified: 2023-10

Locations