NCT04312412

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress95%
Jan 2014Dec 2026

Study Start

First participant enrolled

January 1, 2014

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

December 13, 2021

Status Verified

December 1, 2021

Enrollment Period

12 years

First QC Date

March 4, 2020

Last Update Submit

December 10, 2021

Conditions

Keywords

tendon injuriesflexor tendons

Outcome Measures

Primary Outcomes (8)

  • Range of motion

    Total active motion

    6 weeks

  • Range of motion

    Total active motion

    13 weeks

  • Range of motion

    Total active motion

    26 weeks

  • Range of motion

    Total active motion

    52 weeks

  • Grip or pinch strength

    Strength

    13 weeks

  • Grip or pinch strength

    Strength

    26 weeks

  • Grip or pinch strength

    Strength

    52 weeks

  • Time return to work

    off work time

    52 weeks

Interventions

Rehabilitation, post-surgery protocol

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Primary care clinic

You may qualify if:

  • Injury between 2014 and 2025
  • Flexor tendon injury of the fingers or thumb in zones 1-3

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Clinic of Reconstructive Surgery

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

Related Publications (1)

  • Beckmann-Fries V, Calcagni M, Schrepfer L, Kaempfen A, Vogelin E, Tobler-Ammann B. Relationship between pain, nerve injury and clinical outcomes after flexor tendon injuries in zones 1-2: a retrospective cohort study. Hand Ther. 2023 Jun;28(2):60-71. doi: 10.1177/17589983231159187. Epub 2023 Mar 29.

MeSH Terms

Conditions

Finger InjuriesTendon Injuries

Condition Hierarchy (Ancestors)

Hand InjuriesWounds and Injuries

Study Officials

  • Maurizio Calcagni, PD Dr. med.

    University of Zurich

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

March 4, 2020

First Posted

March 18, 2020

Study Start

January 1, 2014

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

December 13, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations