RecruitingNot ApplicableNCT06836349

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

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


Sponsor

Karolinska Institutet

Enrollment

380 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 15 Years

Inclusion Criteria3

  • 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 Criteria2

  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHEREarly active motion training after operated FPL injury

Early active motion training after operated FPL injury

OTHERImmobilisation in plaster cast 4 weeks after operated FPL injury

Immobilisation in plaster cast 4 weeks after operated FPL injury


Locations(5)

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06836349


Related Trials