Rehabilitation of Finger Flexor Tendon Injuries

Study Overview
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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.

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

Conditions
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Flexor Tendon Rupture

Intervention / Treatment
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* Other: Manchester Short Splint
* Other: Relative Motion Flexion


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |