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

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 Stener lesions. This recommendation is based on expert opinion, anatomic theories and low quality retrospective case series. High quality studies comparing cast immobilization with operative treatment are lacking. Research has shown that in about 9 out of 10 patients, a complete UCL rupture, including Stener Lesions, can also be treated with a cast alone for 6 weeks and no surgery is needed. We hypothesize that cast immobilization is non-inferior regarding functional outcome and carries concomitant lower costs compared with operative treatment for complete UCL ruptures, including Stener Lesions.

The project aims to conduct a multicenter randomized controlled trial and cost-effectiveness analysis comparing operative and nonoperative treatment for complete UCL ruptures, including Stener Lesions. The project will take four years, from preparation to reporting of the results. In the following years, implementation will be achieved in collaboration with the Dutch hand surgery committees (NVvH and NVPC), health insurance companies, and medical experts.

Research question Is nonoperative treatment with splint immobilization non-inferior to immediate operative treatment regarding functional outcome and does it lead to lower costs in adult patients with an acute complete UCL rupture, including Stener Lesions?

Conditions

• Ulnar Collateral Ligament Sprain
• Skier's Thumb

Interventions

PROCEDURE

Cast immobilization

A cast to immobilize the MCP, in 10-30 degrees (slight) flexion (neutral position), and the CMC joint, in 30-40 degrees palmar abduction, is applied (IP joint is free).

PROCEDURE

Surgical treatment

In general, two surgical techniques are described in literature and used in daily clinical practice: * If the UCL is ruptured in the middle of the ligament, sutures are used to reattach the ligament remnants together. * When no viable UCL ligaments are present, the UCL is reattached directly to the bone using suture anchors.

Sponsors & Collaborators

• ZonMw: The Netherlands Organisation for Health Research and Development

  collaborator OTHER

• Diakonessenhuis, Utrecht

  lead OTHER

Principal Investigators

• Mark van Heijl, MD, PhD · Diakonessenhuis, Utrecht

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-02-17

Primary Completion

2025-10-01

Completion

2026-07-31

Countries

• Netherlands

Study Locations