Rehabilitation of Finger Flexor Tendon Injuries

NCT ID: NCT05078476

Last Updated: 2023-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Flexor Tendon Rupture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Manchester Short Splint

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.

Group Type ACTIVE_COMPARATOR

Manchester Short Splint

Intervention Type OTHER

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

Relative Motion Flexion

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.

Group Type EXPERIMENTAL

Relative Motion Flexion

Intervention Type OTHER

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

Interventions

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Manchester Short Splint

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

Intervention Type OTHER

Relative Motion Flexion

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* \< 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bernadette Tobler, Dr. phil.

Role: PRINCIPAL_INVESTIGATOR

Inselspital, Bern Universtiy Hospital

Locations

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Inselspital, Bern University Hospital

Bern, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Tamara Hauri

Role: CONTACT

0041316328319

Facility Contacts

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Tamara Hauri

Role: primary

0041316328319

References

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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.

Reference Type DERIVED
PMID: 37029054 (View on PubMed)

Other Identifiers

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2021-00929

Identifier Type: -

Identifier Source: org_study_id

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