Actively Recruiting
Registry-randomized Comparison of Rehabilitation Regimens After Flexor Pollicis Longus Injury in the Thumb
Led by Karolinska Institutet · Updated on 2026-06-03
380
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
Sponsors
K
Karolinska Institutet
Lead Sponsor
R
Region Stockholm
Collaborating Sponsor
AI-Summary
What this Trial Is About
Flexor tendon injuries in the thumb affect people of all ages and genders, with about 400 surgeries performed annually in Sweden. These injuries require specialized surgery and rehabilitation, as early active motion therapy after surgery is the standard to improve mobility. However, the risk of tendon rupture is higher in the thumb compared to fingers, and there is limited research focused specifically on thumb flexor tendon injuries. This study aims to compare two rehabilitation methods to see if immobilizing the thumb after surgery can reduce rupture rates without harming joint movement or strength. Participants in this registry-randomized clinical trial will be assigned to one of two rehabilitation protocols after thumb flexor tendon surgery: early active motion therapy starting 2-5 days post-operation, or immobilization in a plaster cast for four weeks. The study is conducted at five hand surgery clinics in Sweden, with data collected through the Swedish National Hand Surgery Quality Registry (HAKIR). The trial will evaluate outcomes one year after surgery. During the study, participants will be followed up with assessments at 3 and 12 months post-surgery, including measurements of tendon rupture rates, active joint motion in the thumb, grip and pinch strength, patient-reported questionnaires about hand function and satisfaction with rehabilitation. This comprehensive monitoring will help determine the effects of each rehabilitation approach on recovery and long-term function.
CONDITIONS
Brief Title
Registry-randomized Comparison of Rehabilitation Regimens After Flexor Tendon Injury in the Thumb
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Complete laceration of the thumb flexor tendon (Flexor Pollicis Longus) within zone 1 and 2
- Age over 15 years; minors under 18 must have sufficient maturity to understand the research
- Able to understand spoken and written Swedish
- Surgery performed within 14 days from injury
You will not qualify if you...
- Tendon injury 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 infection signs
- Unsuitable for early active motion therapy due to lack of cooperation, cognitive impairment, or substance abuse
- Patient declines follow-up in the HAKIR quality registry
- Wound infection making early active motion therapy inappropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 weeks postoperatively
Participants undergo rehabilitation regimens after surgery for flexor pollicis longus injury in the thumb, including early active motion training starting 2-5 days postoperatively or immobilisation in a plaster cast for 4 weeks.
1 to 2 visits depending on rehabilitation regimen
Duration - Up to 12 months postoperatively
Participants are followed up to assess tendon rupture rate, range of motion, grip and pinch strength, satisfaction, and questionnaire outcomes at 3 and 12 months postoperatively.
Visits at 3 and 12 months postoperatively
Trial Site Locations
Total: 5 locations
1
Hand- och plastikkirurgiska kliniken Linköpings Universitetssjukhus
Linköping, Sweden
Actively Recruiting
2
Handkirurgiska kliniken Örebros Universitetssjukhus
Örebro, Sweden
Actively Recruiting
3
Handkirurgiska kliniken Södersjukhuset
Stockholm, Sweden
Actively Recruiting
4
Handkirurgiska kliniken Norrlands Universitetssjukhus
Umeå, Sweden
Actively Recruiting
5
Handkirugiska kliniken Uppsala Akademiska Sjukhus
Uppsala, Sweden
Actively Recruiting
Research Team
M
Maria Wilcke, MD, Associate professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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