Back to resultsRehabilitation of Finger Flexor Tendon Injuries
Primary Purpose
Flexor Tendon Rupture
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Manchester Short Splint
Relative Motion Flexion
Sponsored by
About this trial
This is an interventional treatment trial for Flexor Tendon Rupture
Eligibility Criteria
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
Sites / Locations
- Inselspital, Bern University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Manchester Short Splint
Relative Motion Flexion
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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)?
Secondary Outcome Measures
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.
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).
Range of motion
The range of motion will be measured with a goniometry.
Grip Strength
Grip Strength will be measured with the JAMAR Dynamometer.
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.
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.
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.
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.
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.
Rupture rate/ Complications
Tendon rupture will be documented
Complications
complications will be documented (e.g. CRPS, infection)
Full Information
NCT ID
NCT05078476
First Posted
October 13, 2021
Last Updated
June 8, 2023
Sponsor
Insel Gruppe AG, University Hospital Bern
1. Study Identification
Unique Protocol Identification Number
NCT05078476
Brief Title
Rehabilitation of Finger Flexor Tendon Injuries
Official Title
Early Active Motion in the Rehabilitation of Flexor Tendon Injuries: Short Splint Versus Relative Motion: a Pilot Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flexor Tendon Rupture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Manchester Short Splint
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Relative Motion Flexion
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Manchester Short Splint
Intervention Description
3-5 days after tendon repair the patient will start with hand therapy and the described protocol.
Intervention Type
Other
Intervention Name(s)
Relative Motion Flexion
Intervention Description
3-5 days after tendon repair the patient will start with hand therapy and the described protocol.
Primary Outcome Measure Information:
Title
Change in patient satisfaction
Description
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)?
Time Frame
13 and 26 weeks after tendon repair
Secondary Outcome Measure Information:
Title
Michigan Hand Questionnaire (MHQ)
Description
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.
Time Frame
6, 13 and 26 weeks after tendon repair
Title
Disabilities of Shoulder, Arm and Hand Questionnaire
Description
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).
Time Frame
6, 13 and 26 weeks after tendon repair
Title
Range of motion
Description
The range of motion will be measured with a goniometry.
Time Frame
6, 13 and 26 weeks after tendon repair
Title
Grip Strength
Description
Grip Strength will be measured with the JAMAR Dynamometer.
Time Frame
13 and 26 weeks after tendon repair
Title
Level of pain
Description
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.
Time Frame
6, 13 and 26 weeks after tendon repair
Title
Number of therapy sessions
Description
The number of therapy sessions will be counted after 26 weeks or at the end of of therapy if after 26 weeks measurement.
Time Frame
26 weeks after tendon repair
Title
Ten Test
Description
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.
Time Frame
6, 13 and 26 weeks after tendon repair
Title
Patients specific function scale
Description
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.
Time Frame
6, 13 and 26 weeks after tendon repair
Title
Work Productivity and Activity Impairment Questionnaire
Description
The WPAI is a quantitative assessment of absenteeism, presenteeism, and overall productivity loss attributable to a specific health problem during the previous 7 days.
Time Frame
6, 13 and 26 weeks after tendon repair
Title
Rupture rate/ Complications
Description
Tendon rupture will be documented
Time Frame
26 weeks after tendon repair
Title
Complications
Description
complications will be documented (e.g. CRPS, infection)
Time Frame
26 weeks after tendon repair
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tamara Hauri
Phone
0041316328319
Email
tamara.hauri@extern.insel.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernadette Tobler, Dr. phil.
Organizational Affiliation
Inselspital, Bern Universtiy Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inselspital, Bern University Hospital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamara Hauri
Phone
0041316328319
Email
tamara.hauri@extern.insel.ch
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Rehabilitation of Finger Flexor Tendon Injuries
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