Outcome of the Treatment of Flexor Tendon Injuries

• Sponsor: University of Zurich (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04312412
• Collaborator: University Hospital, Basel, Switzerland (Other), University of Bern (Other)
• Enrollment: 500
• Location: 1
• Anticipated Duration (Months): 156
• Patients Per Site Per Month: 3.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Finger Injuries; Tendon Injury - Hand	Procedure: Controlled active motion (CAM)

Study Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Outcomes of Flexor Tendons Repair in Zones I-III From 2014-2025: a Swiss Multicenter Cohort Study
• Actual Study Start Date: Jan 1, 2014
• Anticipated Primary Completion Date: Dec 31, 2025
• Anticipated Study Completion Date: Dec 31, 2026

Outcome Measures

Primary Outcome Measures

1. Range of motion [6 weeks]

   Total active motion

2. Range of motion [13 weeks]

   Total active motion

3. Range of motion [26 weeks]

   Total active motion

4. Range of motion [52 weeks]

   Total active motion

5. Grip or pinch strength [13 weeks]

   Strength

6. Grip or pinch strength [26 weeks]

   Strength

7. Grip or pinch strength [52 weeks]

   Strength

8. Time return to work [52 weeks]

   off work time

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Zurich, Clinic of Reconstructive Surgery	Zurich	ZH	Switzerland	8091

Sponsors and Collaborators

• University of Zurich
• University Hospital, Basel, Switzerland
• University of Bern

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Zurich
• ClinicalTrials.gov Identifier: NCT04312412
• Other Study ID Numbers: BASEC-Nr. 2017-02267
• First Posted: Mar 18, 2020
• Last Update Posted: Dec 13, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Zurich: tendon injuries; flexor tendons
• Additional relevant MeSH terms: Wounds and Injuries; Tendon Injuries; Finger Injuries

Study Results

No Results Posted as of Dec 13, 2021