Status:
ACTIVE_NOT_RECRUITING
RCT on Nonoperative Versus Operative Treatment for Acute Complete tearS of the Ulnar Collateral ligAment of the Thumb
Lead Sponsor:
Diakonessenhuis, Utrecht
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Ulnar Collateral Ligament Sprain
Skier's Thumb
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A complete rupture of the ulnar collateral ligament (UCL) of the thumb must heal in order to regain proper function of the thumb. Guidelines recommend surgery for complete UCL ruptures, including Sten...
Eligibility Criteria
Inclusion
- 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
- \-
Key Trial Info
Start Date :
February 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT05291260
Start Date
February 17 2022
End Date
July 31 2026
Last Update
August 21 2025
Active Locations (1)
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1
Diakonessenhuis Utrecht
Utrecht, Utrecht, Netherlands, 3582KE