Flexor Tendon Injury, Flexor Tendon Rupture, Rehabilitation Program, Thumb Injury
Conditions
Keywords
Flexor pollicis longus injury, RRCT, Early active motion, flexor tendon injury, Thumb, Immobilisation
Brief summary
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).
Interventions
OTHEREarly active motion training after operated FPL injury
Early active motion training after operated FPL injury
OTHERImmobilisation in plaster cast 4 weeks after operated FPL injury
Immobilisation in plaster cast 4 weeks after operated FPL injury
Sponsors
Karolinska Institutet
Region Stockholm
Region Östergötland
Region Västerbotten
Region Örebro County
Uppsala County Council, Sweden
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Registry-randomized controlled trial (RRCT)
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Complete laceration of the thumb flexor tendon (Flexor Pollicis Longus; FPL) within zone 1 and 2. Age over 15 years. Minors (\<18 years) are considered to have sufficient maturity to understand the implications of the research. Swedish-speaking / able to understand spoken and written Swedish. Surgery performed within 14 days from the time of injury.
Exclusion criteria
Tendon injury with a defect requiring tendon grafting. Another complete tendon injury in the same hand. Extensive associated injuries, such as fracture, vascular injury with circulatory impairment, large skin defect, or preoperative signs of infection. Patient deemed unsuitable for early active motion therapy due to factors such as lack of cooperation, cognitive impairment, or substance abuse issues. Patient declines follow-up in the HAKIR quality registry. Wound infection making early active motion therapy inappropriate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tendon rupture rate | Within one year after operation | Clinically diagnosed rupture of an operated flexor pollicis longus injury |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Active range of motion in the joints of the operated thumb MCP joint | 3 and 12 months postoperatively | Active range of motion of the MCP joint of the operated thumb measured with a goniometer |
| Active range of motion of the IP-joint in the opererated thumb | 3 and 12 months postoperatively | Measured with a goniometer |
| Grip strength | 3 and 12 months postoperatively | Measured using a Jamar dynamometer and compared to the uninjured side.gauge. |
| Key pinch strength | 3 and 12 months postoperatively | Key pinch between the thumb and index finger assessed with a pinch gauge. |
| HQ-8 questionnaire | 3 and 12 months postoperatively | A Patient-rated outcome measurse (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, rated from completely dissatisfied to completely satisfied. |
| Quick DASH | 3 and 12 months postoperatively | A patient-rated outcome 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. |
| Overall satisfaction with rehabilitation | 3 and 12 months | Five-point Likert scale of overall satisfaction with rehabilitation: the five response options are: (1) Yes, to a very large extent, (2) Yes, to a large extent, (3) To a certain extent, (4) To a small extent, and (5) Not at all. |
Countries
Sweden
Contacts
CONTACTMaria Wilcke, MD, Associate professor
Outcome results
None listed