Rehabilitation comparison after thumb flexor tendon repair

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

This tests whether starting early active motion or keeping the thumb in a plaster cast for four weeks works better after surgery for a torn thumb flexor tendon in people older than 15.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 380 (estimated)
• Ages: 15 Years and up
• Sex: All
• Sponsor: Karolinska Institutet (Academic / other)
• Locations: 5 sites (Linköping and 4 other locations)
• Trial ID: NCT06836349 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: People older than 15 with a complete laceration of the thumb flexor tendon (FPL) in zone 1 or 2 who have surgical repair within 14 days and can attend Swedish-language follow-up are ideal candidates.

Not a fit: Patients who require tendon grafting, have major associated hand injuries or infection, cannot cooperate with therapy, or cannot participate in Swedish follow-up are unlikely to benefit from this comparison.

Why it matters

Potential benefit: If successful, the results could help clinicians choose a rehab plan that improves thumb motion and reduces re-ruptures after tendon repair.

How similar studies have performed: Previous randomized and observational work on finger flexor tendons has shown early active motion improves mobility compared with immobilization, but randomized evidence specific to thumb FPL repairs is limited.

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.

Where this trial is running

Linköping and 4 other locations

• 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

Conditions Flexor Tendon Injury; Rehabilitation Program; Flexor Tendon Rupture; Thumb Injury; Flexor pollicis longus injury; RRCT; Early active motion; flexor tendon injury