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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-17

Study Completion Date

2026-07-31

Brief Summary

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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?

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Detailed Description

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Conditions

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Ulnar Collateral Ligament Sprain Skier's Thumb

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Not possible for surgical intervention vs cast immobilization

Study Groups

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Cast immobilization

Cast immobilization to immobilize the thumb for 4 weeks. After 2 weeks the thumb will be re-examined to determine if surgery is required. It is expected that at re-evaluation at 2 weeks after starting the cast treatment about 1 in 10 patients will still need surgery.

Group Type EXPERIMENTAL

Cast immobilization

Intervention Type PROCEDURE

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).

Surgery

The intervention is compared to surgery, which is standard treatment for complete ulnar collateral ligament ruptures.

Group Type ACTIVE_COMPARATOR

Surgical treatment

Intervention Type PROCEDURE

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.

Interventions

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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).

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.