Comparing non-surgical and surgical treatments for complete thumb ligament tears
MUlticenter Randomized Controlled Trial on Nonoperative Versus Operative Treatment for Acute Complete tearS of the Ulnar Collateral ligAment of the Thumb: Cost- Effectiveness and Functional Outcomes.
This study is testing whether treating complete thumb ligament tears with a cast works just as well as surgery for recovery and if it's a more affordable option.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Diakonessenhuis, Utrecht Academic / other |
| Locations | 1 site (Utrecht) |
| Trial ID | NCT05291260 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of cast immobilization versus surgical treatment for acute complete tears of the ulnar collateral ligament (UCL) of the thumb, including cases with Stener lesions. The study aims to determine if nonoperative treatment can achieve similar functional outcomes as surgery while being more cost-effective. Participants will be randomly assigned to either treatment group, and their recovery will be monitored to assess the effectiveness of each approach. The trial seeks to fill a gap in high-quality evidence regarding the management of complete UCL ruptures.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have an acute complete UCL rupture diagnosed by a hand surgeon.
Not a fit: Patients with chronic UCL injuries or those who do not meet the diagnostic criteria for a complete rupture may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive and more cost-effective treatment option for patients with complete UCL ruptures.
How similar studies have performed: While there is limited high-quality evidence on this topic, previous studies suggest that nonoperative treatment may be effective, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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: -
Where this trial is running
Utrecht
- Diakonessenhuis Utrecht — Utrecht, Netherlands (Recruiting)
Study contacts
- Principal investigator: Mark van Heijl, MD, PhD — Diakonessenhuis, Utrecht
- Study coordinator: Veronique van de Lücht, MD
- Email: vvdlucht@diakhuis.nl
- Phone: 0882508477
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.