Rehabilitation of Finger Flexor Tendon Injuries

Flexor Tendon Rupture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05078476
• Other study ID #: 2021-00929
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2023
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: Tamara Hauri
• Phone: 0041316328319
• Email: tamara.hauri[@]extern.insel.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Flexor Tendon Rupture
• Rupture
• Tendon Injuries

Intervention

Other:
• Manchester Short Splint
3-5 days after tendon repair the patient will start with hand therapy and the described protocol.
• Relative Motion Flexion
3-5 days after tendon repair the patient will start with hand therapy and the described protocol.

Locations

Country	Name	City	State
Switzerland	Inselspital, Bern University Hospital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Range of motion	The range of motion will be measured with a goniometry.	6, 13 and 26 weeks after tendon repair
Secondary	Grip Strength	Grip Strength will be measured with the JAMAR Dynamometer.	13 and 26 weeks after tendon repair
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Rupture rate/ Complications	Tendon rupture will be documented	26 weeks after tendon repair
Secondary	Complications	complications will be documented (e.g. CRPS, infection)	26 weeks after tendon repair