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Search / Trial NCT05291260

RCT on Nonoperative Versus Operative Treatment for Acute Complete tearS of the Ulnar Collateral ligAment of the Thumb

Launched by DIAKONESSENHUIS, UTRECHT · Mar 21, 2022

Trial Information

Current as of July 04, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the best way to treat a complete tear of the ulnar collateral ligament (UCL) in the thumb, also known as Skier's Thumb. Traditionally, surgery has been recommended for this injury, but recent research suggests that many patients—about 90%—might heal just as well with a cast for six weeks instead. The trial will compare these two treatment methods to see if the cast is just as effective and also more cost-effective than surgery.

To participate in this study, you need to be an adult aged 18 or older and able to speak Dutch or English. You should have a diagnosis of a complete UCL rupture, which will be confirmed by a hand surgeon through specific physical tests. If you join the study, you will either receive a cast or undergo surgery, and researchers will follow your recovery over the next four years to gather important data. Your participation could help improve treatment options for future patients with similar injuries!

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients 18 years and older
  • Dutch or English speaking patients
  • * Patients with an acute complete UCL rupture, with or without a Stener Lesion, diagnosed using physical examination, performed by the hand surgeon. When providing radically directed force to the proximal phalanx (radial deviation stress) as the thumb metacarpal is stabilized, criteria 1 AND 2 must be present to confirm the diagnosis of a complete UCL rupture:
  • no firm endpoint in the MCP joint AND
  • at least more than 35 degrees of laxity in the MCP joint (measured with the MCP joint in extension or in 30 degrees of flexion) OR more than 15 degrees difference in laxity compared with the uninjured side.
  • Exclusion Criteria:
  • -

About Diakonessenhuis, Utrecht

Diakonessenhuis Utrecht is a leading healthcare institution in the Netherlands, renowned for its commitment to providing high-quality patient care and advancing medical research. As a clinical trial sponsor, Diakonessenhuis Utrecht focuses on innovative therapies and treatments across various medical disciplines, fostering collaboration between healthcare professionals and researchers. The institution prioritizes ethical standards and regulatory compliance, ensuring that all trials are designed to enhance patient outcomes and contribute to the scientific community. With a strong emphasis on patient safety and well-being, Diakonessenhuis Utrecht is dedicated to driving advancements in medical science through rigorous research initiatives.

Locations

Utrecht, , Netherlands

Patients applied

0 patients applied

Trial Officials

Mark van Heijl, MD, PhD

Principal Investigator

Diakonessenhuis, Utrecht

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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