NCT05078476

Brief Summary

The primary objective is to compare the two different rehabilitation protocols relative motion flexion and short splint regarding patients'satisfaction in patients with flexor tendon injuries in Zone I and II after 13 and 26 weeks post-surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 14, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

June 9, 2023

Status Verified

June 1, 2023

Enrollment Period

2.7 years

First QC Date

October 13, 2021

Last Update Submit

June 8, 2023

Conditions

Flexor Tendon Rupture

Outcome Measures

Primary Outcomes (1)

  • Change in patient satisfaction

    The satisfaction with the outcome will be evaluated by asking the patient a Single Assessment Numeric Evaluation (SANE) question: "How satisfied are you with your hand on a scale from 0 (not satisfied at all) to 10 (fully satisfied)?

    13 and 26 weeks after tendon repair

Secondary Outcomes (11)

  • Michigan Hand Questionnaire (MHQ)

    6, 13 and 26 weeks after tendon repair

  • Disabilities of Shoulder, Arm and Hand Questionnaire

    6, 13 and 26 weeks after tendon repair

  • Range of motion

    6, 13 and 26 weeks after tendon repair

  • Grip Strength

    13 and 26 weeks after tendon repair

  • Level of pain

    6, 13 and 26 weeks after tendon repair

  • +6 more secondary outcomes

Study Arms (2)

Manchester Short Splint

ACTIVE COMPARATOR

Dorsal splint ending shortly behind the wrist. The splint will be worn for 6 weeks after surgery and the patient will perform active and passive exercises in the splint.

Other: Manchester Short Splint

Relative Motion Flexion

EXPERIMENTAL

In the relative motion splint the injured finger is positioned in relative flexion in the MCP joint to the adjacent fingers. Additionally to the relative motion flexion splint a wrist orthosis is adapted. Passive and active exercises will be performed out of the splint.

Other: Relative Motion Flexion

Interventions

Manchester Short SplintOTHER

3-5 days after tendon repair the patient will start with hand therapy and the described protocol.

Manchester Short Splint
Relative Motion FlexionOTHER

3-5 days after tendon repair the patient will start with hand therapy and the described protocol.

Relative Motion Flexion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent as documented by signature
  • ≥ 18 years old
  • Understanding of the German language (written and oral)
  • Single and multiple finger injuries
  • Primary flexor tendon injuries in Zone I-V for the fingers and/ or thumb
  • Treated by the hand surgery department at the Inselspital Bern
  • Treated with at least a 4-strand core suture

You may not qualify if:

  • \< 18 years old
  • Inability to follow the procedures of the study, e.g. due to language problems, diagnosed psychological disorders or dementia of the patients
  • Replantation of the injured finger
  • Fracture of the injured finger
  • Primary tendon reconstructions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inselspital, Bern University Hospital

Bern, 3010, Switzerland

RECRUITING

Related Publications (1)

  • Hardy M, Feehan L, Savvides G, Wong J. How controlled motion alters the biophysical properties of musculoskeletal tissue architecture. J Hand Ther. 2023 Apr-Jun;36(2):269-279. doi: 10.1016/j.jht.2022.12.003. Epub 2023 Apr 5.

    PMID: 37029054DERIVED

Study Officials

  • Bernadette Tobler, Dr. phil.

    Inselspital, Bern Universtiy Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tamara Hauri

CONTACT

0041316328319tamara.hauri@extern.insel.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2021

First Posted

October 14, 2021

Study Start

December 1, 2021

Primary Completion

July 31, 2024

Study Completion

December 31, 2024

Last Updated

June 9, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)