Flexor Tendon Rupture
Conditions
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.
Interventions
OTHERManchester Short Splint
3-5 days after tendon repair the patient will start with hand therapy and the described protocol.
OTHERRelative Motion Flexion
3-5 days after tendon repair the patient will start with hand therapy and the described protocol.
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in patient satisfaction | 13 and 26 weeks after tendon repair | 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
| Measure | Time frame | Description |
|---|---|---|
| Disabilities of Shoulder, Arm and Hand Questionnaire | 6, 13 and 26 weeks after tendon repair | 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 | 6, 13 and 26 weeks after tendon repair | The range of motion will be measured with a goniometry. |
| Grip Strength | 13 and 26 weeks after tendon repair | Grip Strength will be measured with the JAMAR Dynamometer. |
| Level of pain | 6, 13 and 26 weeks after tendon repair | 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 | 26 weeks after tendon repair | The number of therapy sessions will be counted after 26 weeks or at the end of of therapy if after 26 weeks measurement. |
| Michigan Hand Questionnaire (MHQ) | 6, 13 and 26 weeks after tendon repair | 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. |
| Patients specific function scale | 6, 13 and 26 weeks after tendon repair | 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 | 6, 13 and 26 weeks after tendon repair | 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 | 26 weeks after tendon repair | Tendon rupture will be documented |
| Complications | 26 weeks after tendon repair | complications will be documented (e.g. CRPS, infection) |
| Ten Test | 6, 13 and 26 weeks after tendon repair | 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. |
Countries
Switzerland
Contacts
Primary ContactTamara Hauri
Outcome results
None listed