Clinical trial NCT06836349: Registry-randomized Comparison of Rehabilitation Regimens After Flexor Tendon Injury in the Thumb
Official title: Registry-randomized Comparison of Rehabilitation Regimens After Flexor Pollicis Longus Injury in the Thumb
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Flexor Tendon Injury
Rehabilitation Program
Flexor Tendon Rupture
Thumb Injury
Keywords: Flexor pollicis longus injury
RRCT
Early active motion
flexor tendon injury
Thumb
Immobilisation
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
name: Region Östergötland
name: Region Västerbotten
name: Region Örebro County
name: Uppsala County Council, Sweden
First posted: 2025-02-20
Enrollment: 380
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Registry-randomized controlled trial (RRCT)
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Tendon rupture rate
timeFrame: Within one year after operation
Secondary outcomes:
measure: Active range of motion in the joints of the operated thumb MCP joint
timeFrame: 3 and 12 months postoperatively
measure: Active range of motion of the IP-joint in the opererated thumb
timeFrame: 3 and 12 months postoperatively
measure: Grip strength
timeFrame: 3 and 12 months postoperatively
measure: Key pinch strength
timeFrame: 3 and 12 months postoperatively
measure: HQ-8 questionnaire
timeFrame: 3 and 12 months postoperatively
measure: Quick DASH
timeFrame: 3 and 12 months postoperatively
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Hand- och plastikkirurgiska kliniken Linköpings Universitetssjukhus
city: Stockholm
country: Sweden
facility: Handkirurgiska kliniken Södersjukhuset
city: Umeå
country: Sweden
facility: Handkirurgiska kliniken Norrlands Universitetssjukhus
city: Uppsala
country: Sweden
facility: Handkirugiska kliniken Uppsala Akademiska Sjukhus
city: Örebro
country: Sweden
facility: Handkirurgiska kliniken Örebros Universitetssjukhus
Study officials:
References: