NCT05093946

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 26, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

June 9, 2023

Status Verified

June 1, 2023

Enrollment Period

2.7 years

First QC Date

October 13, 2021

Last Update Submit

June 8, 2023

Conditions

Flexor Tendon Rupture

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Disabilities of Shoulder, Arm and Hand Questionnaire

    6, 13 and 26 weeks after tendon repair]

Eligibility Criteria

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

Patients with flexor tendon injuries in Zone I-V for in the fingers and/or thumb.

You may qualify if:

  • 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

You may not qualify if:

  • \< 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inselspital, Bern University Hospital

Bern, 3010, Switzerland

RECRUITING

Study Officials

  • Bernadette Tobler, Dr. phil.

    Inselspital, Bern University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tamara Hauri

CONTACT

00413116328319tamara.hauri@extern.insel.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2021

First Posted

October 26, 2021

Study Start

December 1, 2021

Primary Completion

July 31, 2024

Study Completion

December 31, 2024

Last Updated

June 9, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)