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Registry-randomized Comparison of Rehabilitation Regimens After Flexor Tendon Injury in the Thumb

RecruitingNAAges 15 Years - anyAllKarolinska Institutet
NCT06836349 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 r

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📋 Eligibility rules (as published)
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.
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What it tests

  • Early active motion training after operated FPL injury
  • Immobilisation in plaster cast 4 weeks after operated FPL injury
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Where

5 sites
Hand- och plastikkirurgiska kliniken Linköpings Universitetssjukhus
Linköping, Sweden
Handkirurgiska kliniken Örebros Universitetssjukhus
Örebro, Sweden
Handkirurgiska kliniken Södersjukhuset
Stockholm, Sweden
Handkirurgiska kliniken Norrlands Universitetssjukhus
Umeå, Sweden
Handkirugiska kliniken Uppsala Akademiska Sjukhus
Uppsala, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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