Digital Nerve InjuryNCT05337917
Digital Nerve Injury - a Case Control Study
An observational study of Digital Nerve Injury, run by Karolinska Institutet at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Digital Nerve Injury
- What is being tested?
- Surgical of the digital nerve
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 144 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2021to 30 Dec 2022
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
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).
- treatment completed in Södersjukhuset hospital 2012 - 2018
Who cannot join
- concomitant skeletal injury,
- amputations
- severe soft tissue injuries
- microvascular reconstruction
- residence outside the Stockholm region
- patient age below 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Hand Function and Sensation Following Digital Nerve Injury and Repair- a Case Control Study.
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.
Read the detailed description
Eligible patients are individuals treated at the Department of Hand surgery in Stockholm, Sweden during 2012-2018. Inclusion criteria include 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 are concomitant flexor tendon injury and/or skeletal injury, amputations, and severe soft tissue injuries. Patients residing outside the Stockholm region and children below 18 years of age are also excluded. Initially a total number of 1330 patients have been identified. All medical records have been thoroughly scrutinized. After excluding concomitant tendon injury, a total of 606 patients remained with isolated digital nerve injury. A randomly selected sample of participants have been assigned to two groups: Patients with an injury to the digital nerve of the thumb, digit II radial side, digit V ulnar side were assigned to the "case" group and matched "controls" were randomly selected among patients with an injury to the digital nerves of either the ulnar side of digit II, either nerve of digit III and digit IV or the radial nerve of digit V. Cases and controls have been matched according to sex, year of injury and patient age.
For the purpose of this study, a clinical evaluation to investigate hand function, sensory function, strength, and ability to discriminate warm and cold and sharp and dull will be conducted. Questionnaires are used for Patient Reported Outcome Measures (PROM): Disability of the Arm Shoulder, and Hand (QuickDASH), Patient questionnaire HQ8 arm and hand (HQ8), The Hospital Anxiety and Depression Scale (HADS), Saltin-Grimby Physical Activity Level Scale (SGPALS), and in addition Douleur Neuropathique en 4 Questions (DN4) for assessment of neuropathic pain will be performed. All outcomes will be compared between groups defined as case (digital injury to the thumb, radial nerve of the index finger or ulnar nerve of the little finger) or control (all other digital nerve injuries).
- Conditions
- Digital Nerve Injury
- Being tested
- Surgical of the digital nerve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical of the digital nerveProcedure or surgery
All patients (cases and controls) were subject to surgical repair of digital nerve injury.
| Study group | Role | What they receive |
|---|---|---|
| Case | Injury to digital nerve: thumb, digit II radial side, digit V ulnar side Receives: Procedure: Surgical of the digital nerve | |
| Control | Injury to digital nerve: digit II ulnarside, dig III, dig IV dig V radial side. Receives: Procedure: Surgical of the digital nerve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Handfunction
Measured by Mini Sollerman test for handfunction.
Measured: 3-10 years post operatively
Secondary outcomes (11)
Sensation
Semmes Weinstein, Static two point discrimination
Measured: 3-10 years post operatively
Sensation
Static two point discrimination
Measured: 3-10 years post operatively
Patient Rated Outcome Measure (PROM) for hand function
QuickDASH (Disability of the Arm Shoulder and Hand)
Measured: 3-10 yrs post op
PROM for hand function
HQ8 (HAKIR Questionnaire 8 questions)
Measured: 3-10 yrs post op
PROM for hand function
SGPALS (Saltin-Grimby Physical Activity Level Scale)
Measured: 3-10 yrs post op
PROM for neuropathic pain
DN4 (Douleur neuropathique 4 levels)
Measured: 3-10 yrs post op
PROM for depression and anxiety
HADS (Hospital Anxiety and Depression Scale)
Measured: 3-10 yrs post op
PROM
Physical activity scale.
Measured: 3-10 yrs post op
Range of motion
Goniometer measurements of finger joints
Measured: 3-10 yrs post op
Pinch strength
Grip strength as measured by Pinch gauge
Measured: 3-10 yrs post op
Strength
Grip strength as measured by JAMAR
Measured: 3-10 yrs post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start1 Sep 2021
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cecilia Mellstrand Navarro, Karolinska Institutet
- Investigators
- Cecilia Mellstrand Navarro, MD Prof, Principal investigator, Region Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337917
- Sponsor's protocol ID
- Digital nerve clinical results
- Status last verified
- Oct 2023
- First submitted
- 29 Jan 2022
- Last updated
- 4 Oct 2023
- 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 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Hand Function and Sensation Following Digital Nerve Injury and Repair- a Case Control Study.
- ClinicalTrials.gov ID
- NCT05337917
- Acronym / sponsor ID
- Digital nerve clinical results
- Conditions
- Digital Nerve Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 20 Apr 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.
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.
Detailed description
Eligible patients are individuals treated at the Department of Hand surgery in Stockholm, Sweden during 2012-2018. Inclusion criteria include 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 are concomitant flexor tendon injury and/or skeletal injury, amputations, and severe soft tissue injuries. Patients residing outside the Stockholm region and children below 18 years of age are also excluded. Initially a total number of 1330 patients have been identified. All medical records have been thoroughly scrutinized. After excluding concomitant tendon injury, a total of 606 patients remained with isolated digital nerve injury. A randomly selected sample of participants have been assigned to two groups: Patients with an injury to the digital nerve of the thumb, digit II radial side, digit V ulnar side were assigned to the "case" group and matched "controls" were randomly selected among patients with an injury to the digital nerves of either the ulnar side of digit II, either nerve of digit III and digit IV or the radial nerve of digit V. Cases and controls have been matched according to sex, year of injury and patient age.
For the purpose of this study, a clinical evaluation to investigate hand function, sensory function, strength, and ability to discriminate warm and cold and sharp and dull will be conducted. Questionnaires are used for Patient Reported Outcome Measures (PROM): Disability of the Arm Shoulder, and Hand (QuickDASH), Patient questionnaire HQ8 arm and hand (HQ8), The Hospital Anxiety and Depression Scale (HADS), Saltin-Grimby Physical Activity Level Scale (SGPALS), and in addition Douleur Neuropathique en 4 Questions (DN4) for assessment of neuropathic pain will be performed. All outcomes will be compared between groups defined as case (digital injury to the thumb, radial nerve of the index finger or ulnar nerve of the little finger) or control (all other digital nerve injuries).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Procedure: Surgical of the digital nerveInjury to digital nerve: thumb, digit II radial side, digit V ulnar side |
| Control | – | Procedure: Surgical of the digital nerveInjury to digital nerve: digit II ulnarside, dig III, dig IV dig V radial side. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 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).
- treatment completed in Södersjukhuset hospital 2012 - 2018
Key exclusion criteria (6 listed)
- concomitant skeletal injury,
- amputations
- severe soft tissue injuries
- microvascular reconstruction
- residence outside the Stockholm region
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 |
|---|---|---|
| Surgical of the digital nerveAll patients (cases and controls) were subject to surgical repair of digital nerve injury. | Procedure or surgery | Case, Control |
Primary outcome
Handfunction
Time frame: 3-10 years post operatively
Measured by Mini Sollerman test for handfunction.
11 secondary outcomes
Sensation
Time frame: 3-10 years post operatively
Sensation
Time frame: 3-10 years post operatively
Patient Rated Outcome Measure (PROM) for hand function
Time frame: 3-10 yrs post op
PROM for hand function
Time frame: 3-10 yrs post op
PROM for hand function
Time frame: 3-10 yrs post op
PROM for neuropathic pain
Time frame: 3-10 yrs post op
PROM for depression and anxiety
Time frame: 3-10 yrs post op
PROM
Time frame: 3-10 yrs post op
Range of motion
Time frame: 3-10 yrs post op
Pinch strength
Time frame: 3-10 yrs post op
Strength
Time frame: 3-10 yrs post op
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 4 Oct 2023.
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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.
Cecilia Mellstrand Navarro, MD Prof principal investigator
Region Stockholm
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 2 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 4 Oct 2023. 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?
Handfunction (time frame: 3-10 years post operatively). 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 4 Oct 2023.