Rehabilitation of Finger Flexor Tendon Injuries

Early Active Motion in the Rehabilitation of Flexor Tendon Injuries: Short Splint Versus Relative Motion: a Pilot Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Flexor Tendon Rupture
• Intervention / Treatment: Other: Manchester Short Splint; Other: Relative Motion Flexion

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tamara Hauri; Phone Number: 0041316328319; Email: tamara.hauri@extern.insel.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • Inselspital, Bern University Hospital
    • Contact: Tamara Hauri; Phone Number: 0041316328319; Email: tamara.hauri@extern.insel.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: Manchester Short Splint; 3-5 days after tendon repair the patient will start with hand therapy and the described protocol.
Experimental: 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.	Other: Relative Motion Flexion; 3-5 days after tendon repair the patient will start with hand therapy and the described protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Michigan Hand Questionnaire (MHQ)	The MHQ is a hand specific questionnaire used to measure the ability in daily function. The total score ranges from 0 to 100, with higher scores indicating better performance.	6, 13 and 26 weeks after tendon repair
Disabilities of Shoulder, Arm and Hand Questionnaire	The DASH questionnaire is a region-specific outcome instrument. The patient will rate 30-items about disability or symptoms by rating the degree of difficulty in doing various activities. The scores of all items are used to calculate a score ranging from 0 (no disability) to 100 (most severe disability).	6, 13 and 26 weeks after tendon repair
Range of motion	The range of motion will be measured with a goniometry.	6, 13 and 26 weeks after tendon repair
Grip Strength	Grip Strength will be measured with the JAMAR Dynamometer.	13 and 26 weeks after tendon repair
Level of pain	The patient will be asked to rate the pain from 0 to 10. 0 indicates no pain, 10 the worst possible pain. The patient rate the pain while relaxed and during exercises.	6, 13 and 26 weeks after tendon repair
Number of therapy sessions	The number of therapy sessions will be counted after 26 weeks or at the end of of therapy if after 26 weeks measurement.	26 weeks after tendon repair
Ten Test	The Ten Test is a measure of discriminative sensation, whereby the patient describes the sensation from no sensation "0" to normal sensation "10" on an 11-point Likert scale.	6, 13 and 26 weeks after tendon repair
Patients specific function scale	The patient defines three to five activities that are difficult or that he/she is unable to perform due to the hand injury. The patient is asked to rate the difficulty associated with each activity from 0 to 10. 0 is defined as not able to do the activity and 10 is able to do the activity normally.	6, 13 and 26 weeks after tendon repair
Work Productivity and Activity Impairment Questionnaire	The WPAI is a quantitative assessment of absenteeism, presenteeism, and overall productivity loss attributable to a specific health problem during the previous 7 days.	6, 13 and 26 weeks after tendon repair
Rupture rate/ Complications	Tendon rupture will be documented	26 weeks after tendon repair
Complications	complications will be documented (e.g. CRPS, infection)	26 weeks after tendon repair

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Investigators: Principal Investigator: Bernadette Tobler, Dr. phil., Inselspital, Bern Universtiy Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: October 13, 2021
• First Submitted That Met QC Criteria: October 13, 2021
• First Posted (Actual): October 14, 2021

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: June 8, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Tendon Injuries
• Other Study ID Numbers: 2021-00929

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No