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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05093946
Other study ID # 2021-00929a
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2021
Est. completion date December 31, 2024

Study information

Verified date June 2023
Source Insel Gruppe AG, University Hospital Bern
Contact Tamara Hauri
Phone 00413116328319
Email tamara.hauri@extern.insel.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of the study is to investigate the psychometric properties of the German Version of the Michigan Hand Questionnaire in patients with flexor tendon injuries, including reliability, validity and interpretability.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 31, 2024
Est. primary completion date July 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Informed consent as documented by signature - = 18 years old - Understanding of the German language (written and oral) - Single and multiple finger injuries - Primary flexor tendon injuries in Zone I-V for the fingers and/ or thumb - Treated by the hand surgery department at the Inselspital Bern - Treated with at least a 4-strand core suture Exclusion Criteria: - < 18 years old - Inability to follow the procedures of the study, e.g. due to language problems, diagnosed psychological disorders or dementia of the patients - Replantation of the injured finger - Fracture of the injured finger - Primary tendon reconstructions

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Switzerland Inselspital, Bern University Hospital Berne

Sponsors (1)

Lead Sponsor Collaborator
Insel Gruppe AG, University Hospital Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Michigan Hand Questionnaire (MHQ) The MHQ is a hand specific questionnaire used to measure the ability in daily function. The total score ranges from 0 to 100, with higher scores indicating better performance. 6, 13, 13 1/2 and 26 weeks after tendon repair
Secondary Disabilities of Shoulder, Arm and Hand Questionnaire The DASH questionnaire is a region-specific outcome instrument. The patient will rate 30-items about disability or symptoms by rating the degree of difficulty in doing various activities. The scores of all items are used to calculate a score ranging from 0 (no disability) to 100 (most severe disability). The DASH is a region-specific outcome instrument. The patient will rate 30-items about disability or symptoms by rating the degree of difficulty in doing various activities. The scores of all items are used to calculate a score ranging from 0 (no disability) to 100 (most severe disability). 6, 13 and 26 weeks after tendon repair]
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