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

Last updated: June 1, 2025
Sponsor: Karolinska Institutet
Overall Status: Active - Recruiting

Phase

N/A

Condition

Tendon Injuries

Treatment

Immobilisation in plaster cast 4 weeks after operated FPL injury

Early active motion training after operated FPL injury

Clinical Study ID

NCT06836349
RRCT HAKIR fpl
  • Ages > 15
  • All Genders

Study 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

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

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.

Study Design

Total Participants: 380
Treatment Group(s): 2
Primary Treatment: Immobilisation in plaster cast 4 weeks after operated FPL injury
Phase:
Study Start date:
May 01, 2025
Estimated Completion Date:
December 31, 2031

Connect with a study center

  • Hand- och plastikkirurgiska kliniken Linköpings Universitetssjukhus

    Linköping,
    Sweden

    Active - Recruiting

  • Handkirurgiska kliniken Södersjukhuset

    Stockholm,
    Sweden

    Active - Recruiting

  • Handkirurgiska kliniken Norrlands Universitetssjukhus

    Umeå,
    Sweden

    Active - Recruiting

  • Handkirugiska kliniken Uppsala Akademiska Sjukhus

    Uppsala,
    Sweden

    Active - Recruiting

  • Handkirurgiska kliniken Örebros Universitetssjukhus

    Örebro,
    Sweden

    Active - Recruiting

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