Outcome of the Treatment of Flexor Tendon Injuries

December 10, 2021 updated by: University of Zurich

Outcomes of Flexor Tendons Repair in Zones I-III From 2014-2025: a Swiss Multicenter Cohort Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Primary care clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of motion
Time Frame: 6 weeks
Total active motion
6 weeks
Range of motion
Time Frame: 13 weeks
Total active motion
13 weeks
Range of motion
Time Frame: 26 weeks
Total active motion
26 weeks
Range of motion
Time Frame: 52 weeks
Total active motion
52 weeks
Grip or pinch strength
Time Frame: 13 weeks
Strength
13 weeks
Grip or pinch strength
Time Frame: 26 weeks
Strength
26 weeks
Grip or pinch strength
Time Frame: 52 weeks
Strength
52 weeks
Time return to work
Time Frame: 52 weeks
off work time
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Collaborators

University Hospital, Basel, Switzerland
University of Bern

Investigators

  • Principal Investigator: Maurizio Calcagni, PD Dr. med., University of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2014

Primary Completion (ANTICIPATED)

December 31, 2025

Study Completion (ANTICIPATED)

December 31, 2026

Study Registration Dates

First Submitted

March 4, 2020

First Submitted That Met QC Criteria

March 17, 2020

First Posted (ACTUAL)

March 18, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 13, 2021

Last Update Submitted That Met QC Criteria

December 10, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BASEC-Nr. 2017-02267

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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