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Search / Trial NCT06836349

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

Launched by KAROLINSKA INSTITUTET · Feb 14, 2025

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Flexor Pollicis Longus Injury Rrct Early Active Motion Flexor Tendon Injury Thumb Immobilisation

ClinConnect Summary

This clinical trial is studying two different rehabilitation methods for patients who have had surgery for a thumb flexor tendon injury, which is a common type of injury that can occur in people of all ages. The main goal is to see if keeping the thumb in a cast for four weeks after surgery will lower the risk of the tendon re-rupturing compared to starting early movement therapy right after surgery. Researchers want to find out if these two approaches affect how well patients can move their thumbs and how strong they feel a year after the surgery.

To participate in the trial, individuals must be over 15 years old and have a complete tear of the thumb flexor tendon (the tendon that helps bend the thumb). They should be able to understand Swedish since the trial will involve communication in that language. Participants will be followed up for a year to assess their recovery, and their experiences will be recorded in a national quality registry. It's important to note that those with certain complications or other severe injuries may not be eligible for this study.

Gender

ALL

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.

About Karolinska Institutet

Karolinska Institutet is a renowned medical university located in Sweden, recognized for its commitment to advancing healthcare through innovative research and education. As a leading sponsor of clinical trials, the institution focuses on translating scientific discoveries into effective treatments and therapies, emphasizing patient-centered approaches. With a strong emphasis on collaboration and interdisciplinary research, Karolinska Institutet plays a pivotal role in addressing global health challenges and improving patient outcomes, leveraging its extensive network of experts and state-of-the-art facilities to drive clinical advancements.

Locations

Linköping, , Sweden

Stockholm, , Sweden

Umeå, , Sweden

Uppsala, , Sweden

örebro, , Sweden

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported