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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04312412
Other study ID # BASEC-Nr. 2017-02267
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2014
Est. completion date December 31, 2026

Study information

Verified date December 2021
Source University of Zurich
Contact Vera Beckmann-Fries
Phone +41 44 255 51 24
Email vera.beckmann-fries@usz.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In order to gather enough data for meaningful statistics, a multicenter register of all flexor tendon repairs was established with surgical, clinical and rehabilitation patient data. The controlled active motion (CAM) protocol was administered in all patients after surgery. The purpose was to (i) measure surgery and therapy outcomes in the three centers and (ii) evaluate potential influencing factors on outcomes.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date December 31, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Injury between 2014 and 2025 - Flexor tendon injury of the fingers or thumb in zones 1-3 Exclusion Criteria: - No given consent - Concomitant injuries as fractures, large soft tissue injuries, replantation - Bony avulsion fracture of flexor tendon (Jersey finger) - Basic disease as rheumatoid diseases - Primary and secondary tendon reconstruction and tendon transfer

Study Design


Intervention

Procedure:
Controlled active motion (CAM)
Rehabilitation, post-surgery protocol

Locations

Country Name City State
Switzerland University Hospital Zurich, Clinic of Reconstructive Surgery Zurich ZH

Sponsors (3)

Lead Sponsor Collaborator
University of Zurich University Hospital, Basel, Switzerland, University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Range of motion Total active motion 6 weeks
Primary Range of motion Total active motion 13 weeks
Primary Range of motion Total active motion 26 weeks
Primary Range of motion Total active motion 52 weeks
Primary Grip or pinch strength Strength 13 weeks
Primary Grip or pinch strength Strength 26 weeks
Primary Grip or pinch strength Strength 52 weeks
Primary Time return to work off work time 52 weeks
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