Psychometric Measurement Properties of the Michigan Hand Questionnaire in Patients After Flexor Tendon Repair

Flexor Tendon Rupture Clinical Trial

Official title:

Psychometric Measurement Properties of the German Version of the Michigan Hand Questionnaire in Patients After Flexor Tendon Repair

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05093946
• Other study ID #: 2021-00929a
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Flexor Tendon Rupture
• Rupture

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]