Flexor tendon injuries in the thumb occur across all ages and genders. Each year, approximately 400 patients undergo surgery for a flexor tendon injury in Sweden. These injuries are exclusively treated at one of the seven specialized hand surgery clinics, as the surgery is technically demanding, and postoperative rehabilitation is critical, specialized, and requires expertise from hand therapists. To prevent tendon adhesions and stiffness in the thumb or fingers, controlled active motion therapy is usually initiated within a few days after surgery. Studies on finger flexor tendon injuries have shown that early active movement therapy leads to better mobility compared to immobilization. Consequently, early active training is now the standard treatment following flexor tendon repair. However, during postoperative rehabilitation, the repaired flexor tendon may rupture, often necessitating revision surgery. The rupture rate after flexor tendon repair in the thumb is approximately three times higher than in other fingers (10% vs. 3%). While most studies on flexor tendon injuries focus on finger tendons, research on the outcomes of thumb flexor tendon injuries is limited. The biomechanics and anatomy of the thumb's flexor tendon differ significantly from those of finger tendons. The objective of this study is to determine whether the rupture rate following thumb flexor tendon surgery can be reduced by immobilizing the thumb in a cast for four weeks postoperatively, compared to standard early active motion therapy, without negatively affecting joint mobility and thumb strength. Additionally, the study will evaluate patient-reported outcomes one year post-surgery for both rehabilitation regimens (immobilization vs. mobilization). This study is a registry-randomized clinical trial (RRCT) involving five hand surgery clinics in Sweden. Data following randomization between the two rehabilitation protocols will be collected through follow-up in the Swedish National Hand Surgery Quality Registry (HAKIR).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
380
Early active motion training after operated FPL injury
Immobilisation in plaster cast 4 weeks after operated FPL injury
Hand- och plastikkirurgiska kliniken Linköpings Universitetssjukhus
Linköping, Sweden
RECRUITINGHandkirurgiska kliniken Örebros Universitetssjukhus
Örebro, Sweden
RECRUITINGHandkirurgiska kliniken Södersjukhuset
Stockholm, Sweden
RECRUITINGHandkirurgiska kliniken Norrlands Universitetssjukhus
Umeå, Sweden
RECRUITINGHandkirugiska kliniken Uppsala Akademiska Sjukhus
Uppsala, Sweden
RECRUITINGTendon rupture rate
Clinically diagnosed rupture of an operated flexor pollicis longus injury
Time frame: Within one year after operation
Active range of motion in the joints of the operated thumb MCP joint
Active range of motion of the MCP joint of the operated thumb measured with a goniometer
Time frame: 3 and 12 months postoperatively
Active range of motion of the IP-joint in the opererated thumb
Measured with a goniometer
Time frame: 3 and 12 months postoperatively
Grip strength
Measured using a Jamar dynamometer and compared to the uninjured side.gauge.
Time frame: 3 and 12 months postoperatively
Key pinch strength
Key pinch between the thumb and index finger assessed with a pinch gauge.
Time frame: 3 and 12 months postoperatively
HQ-8 questionnaire
A Patient-rated outcpme measurs (PROM).The HAKIR questionnaire (HQ-8) consists of seven questions regarding symptoms in the operated hand, such as aching, pain, numbness, weakness, and cold sensitivity, as well as one question on perceived hand function. All questions are answered on a 0-100 scale (0, 10, 20, etc.). An additional question in the questionnaire addresses satisfaction with the surgical outcome and the experience of staff interactions during the given care, rated from completely dissatisfied to completely satisfied.
Time frame: 3 and 12 months postoperatively
Quick DASH
A patient-rated outcpme measure. (PROM. The short version of the Disabilities of the Arm, Shoulder, and Hand (QuickDASH) contains 11 questions covering activity limitations, symptoms, and participation. The responses are summed into a total score ranging from 0 to 100, where 100 represents maximum perceived disability of the hand and arm.
Time frame: 3 and 12 months postoperatively
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