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

Recruiting

• Conditions: Flexor Tendon Rupture

• Registration Number: NCT05093946
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-13
• Study First Submitted QC: 2021-10-13
• Study First Posted: 2021-10-26
• Study Start: 2021-12-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-08
• Last Update Posted: 2023-06-09
• Primary Completion: 2024-07-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Michigan Hand Questionnaire (MHQ)	6, 13, 13 1/2 and 26 weeks after tendon repair	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.

Secondary Outcome Measures

Name	Time	Method
Disabilities of Shoulder, Arm and Hand Questionnaire	6, 13 and 26 weeks after tendon repair]	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).

Trial Locations

Locations (1)

Inselspital, Bern University Hospital; 🇨🇭 Berne, Switzerland