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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05078476
Other study ID # 2021-00929
Secondary ID
Status Recruiting
Phase N/A
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 0041316328319
Email tamara.hauri@extern.insel.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective is to compare the two different rehabilitation protocols relative motion flexion and short splint regarding patients'satisfaction in patients with flexor tendon injuries in Zone I and II after 13 and 26 weeks post-surgery.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
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


Intervention

Other:
Manchester Short Splint
3-5 days after tendon repair the patient will start with hand therapy and the described protocol.
Relative Motion Flexion
3-5 days after tendon repair the patient will start with hand therapy and the described protocol.

Locations

Country Name City State
Switzerland Inselspital, Bern University Hospital Bern

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 patient satisfaction The satisfaction with the outcome will be evaluated by asking the patient a Single Assessment Numeric Evaluation (SANE) question: "How satisfied are you with your hand on a scale from 0 (not satisfied at all) to 10 (fully satisfied)? 13 and 26 weeks after tendon repair
Secondary 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 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). 6, 13 and 26 weeks after tendon repair
Secondary Range of motion The range of motion will be measured with a goniometry. 6, 13 and 26 weeks after tendon repair
Secondary Grip Strength Grip Strength will be measured with the JAMAR Dynamometer. 13 and 26 weeks after tendon repair
Secondary Level of pain The patient will be asked to rate the pain from 0 to 10. 0 indicates no pain, 10 the worst possible pain. The patient rate the pain while relaxed and during exercises. 6, 13 and 26 weeks after tendon repair
Secondary Number of therapy sessions The number of therapy sessions will be counted after 26 weeks or at the end of of therapy if after 26 weeks measurement. 26 weeks after tendon repair
Secondary Ten Test The Ten Test is a measure of discriminative sensation, whereby the patient describes the sensation from no sensation "0" to normal sensation "10" on an 11-point Likert scale. 6, 13 and 26 weeks after tendon repair
Secondary Patients specific function scale The patient defines three to five activities that are difficult or that he/she is unable to perform due to the hand injury. The patient is asked to rate the difficulty associated with each activity from 0 to 10. 0 is defined as not able to do the activity and 10 is able to do the activity normally. 6, 13 and 26 weeks after tendon repair
Secondary Work Productivity and Activity Impairment Questionnaire The WPAI is a quantitative assessment of absenteeism, presenteeism, and overall productivity loss attributable to a specific health problem during the previous 7 days. 6, 13 and 26 weeks after tendon repair
Secondary Rupture rate/ Complications Tendon rupture will be documented 26 weeks after tendon repair
Secondary Complications complications will be documented (e.g. CRPS, infection) 26 weeks after tendon repair
See also
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