Finger InjuriesNCT04312412
Outcome of the Treatment of Flexor Tendon Injuries
An observational study of Finger Injuries and Tendon Injury - Hand, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Finger Injuries, Tendon Injury - Hand
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2014to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- Injury between 2014 and 2025
- Flexor tendon injury of the fingers or thumb in zones 1-3
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich, Clinic of Reconstructive Surgery
Zurich, Canton of Zurich, 8091
Maurizio Calcagni, maurizio.calcagni@usz.ch
vera beckmann, vera.beckmann@usz.ch
About this study
Official title: 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.
- Conditions
- Finger Injuries, Tendon Injury - Hand
- Being tested
- Controlled active motion (CAM)
- Keywords
- tendon injuries, flexor tendons
- Medical subject headings
- Finger Injuries, Tendon Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled active motion (CAM)Procedure or surgery
Rehabilitation, post-surgery protocol
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion
Total active motion
Measured: 6 weeks
Range of motion
Total active motion
Measured: 13 weeks
Range of motion
Total active motion
Measured: 26 weeks
Range of motion
Total active motion
Measured: 52 weeks
Grip or pinch strength
Strength
Measured: 13 weeks
Grip or pinch strength
Strength
Measured: 26 weeks
Grip or pinch strength
Strength
Measured: 52 weeks
Time return to work
off work time
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start1 Jan 2014
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Finger InjuriesStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland, University of Bern
- Responsible party
- Sponsor
- Investigators
- Maurizio Calcagni, PD Dr. med., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04312412
- Sponsor's protocol ID
- BASEC-Nr. 2017-02267
- Status last verified
- Dec 2021
- First submitted
- 4 Mar 2020
- Last updated
- 13 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37904861
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Flexor Tendons Repair in Zones I-III From 2014-2025: a Swiss Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT04312412
- Acronym / sponsor ID
- BASEC-Nr. 2017-02267
- Conditions
- Finger Injuries, Tendon Injury - Hand
- Keywords
- tendon injuries, flexor tendons
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland, University of Bern
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (2 listed)
- Injury between 2014 and 2025
- Flexor tendon injury of the fingers or thumb in zones 1-3
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Controlled active motion (CAM)Rehabilitation, post-surgery protocol | Procedure or surgery | – |
Primary outcome
Range of motion
Time frame: 6 weeks
Total active motion
Range of motion
Time frame: 13 weeks
Total active motion
Range of motion
Time frame: 26 weeks
Total active motion
Range of motion
Time frame: 52 weeks
Total active motion
Grip or pinch strength
Time frame: 13 weeks
Strength
Grip or pinch strength
Time frame: 26 weeks
Strength
Grip or pinch strength
Time frame: 52 weeks
Strength
Time return to work
Time frame: 52 weeks
off work time
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2021.
- Derived from this study: PubMed 37904861Beckmann-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maurizio Calcagni, PD Dr. med. principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Finger Injuries and Tendon Injury - Hand, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vera Beckmann-Fries (+41 44 255 51 24, vera.beckmann-fries@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion (time frame: 6 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04312412, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2021.