Rehabilitation comparison after thumb flexor tendon repair

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This registry-randomized trial compares two postoperative rehabilitation approaches after surgical repair of the flexor pollicis longus (FPL) tendon in the thumb: early active motion versus four weeks of immobilization in a plaster cast. Patients with complete zone 1 or 2 FPL lacerations who have surgery within 14 days are randomized at participating specialized hand surgery centers in Sweden and followed through the national HAKIR registry. Outcomes include thumb mobility, function, and tendon rupture or need for reoperation, with routine follow-up by hand therapists. The trial leverages centralized registry data and standardized clinic protocols to capture real-world outcomes across multiple centers.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hand- och plastikkirurgiska kliniken Linköpings Universitetssjukhus
  Linköping, Sweden Recruiting
• Handkirurgiska kliniken Örebros Universitetssjukhus
  Örebro, Sweden Recruiting
• Handkirurgiska kliniken Södersjukhuset
  Stockholm, Sweden Recruiting
• Handkirurgiska kliniken Norrlands Universitetssjukhus
  Umeå, Sweden Recruiting
• Handkirugiska kliniken Uppsala Akademiska Sjukhus
  Uppsala, Sweden Recruiting

Study contacts

• Study coordinator: Maria Wilcke, MD, Associate professor
• Email: maria.wilcke@ki.se
• Phone: +46812362022

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.