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

NCT05291260 | Active Not Recruiting DMC

• 1 other identifier: NL78886.100.21
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (1)

• Michigan Hand outcome Questionnaire (MHQ)

  The MHQ, expressed as the MHQ at 6 months (from randomization to 6 months after) is the primary endpoint of the study. The MHQ is a validated tool for assessment of functional outcome in patients with pathology of the hand. The MHQ is a questionnaire divided in six subscales; overall hand function, activities of daily living (ADLs), pain, work performance, aesthetics and patient satisfaction with hand function. Each subscale has a formula to calculate a score. The final score is a summation of the six individual item-scores divided by six and goes from 0 (severe disability) to 100 (no disability).

  6 months

Secondary Outcomes (12)

• Patient-Specific Functional Scale (PSFS)

  at randomization, 2, 3, 6 and 12 months after randomization.

• EQ-5D-5L

  at randomization, 2, 3, 6 and 12 months after randomization.

• Michigan Hand outcome Questionnaire (MHQ)

  at randomization, 2, 3 and 12 months after randomization.

• The Numeric Pain Rating Scale (NPRS)

  at randomization, 2, 3, 6 and 12 months after randomization.

• Patient satisfaction

  at randomization, 2, 3, 6 and 12 months after randomization.

Study Arms (2)

Cast immobilization

EXPERIMENTAL

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.

Procedure: Cast immobilization

Surgery

ACTIVE COMPARATOR

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

Procedure: Surgical treatment

Interventions

Cast immobilization 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).

Cast immobilization

Surgical treatment 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.

Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Diakonessenhuis, Utrecht: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

Diakonessenhuis Utrecht

Utrecht, Utrecht, 3582KE, Netherlands

Location

Related Publications (6)

• Pulos N, Shin AY. Treatment of Ulnar Collateral Ligament Injuries of the Thumb: A Critical Analysis Review. JBJS Rev. 2017 Feb 21;5(2):e3. doi: 10.2106/JBJS.RVW.16.00051. No abstract available.

  PMID: 28248741 BACKGROUND

• Pichora DR, McMurtry RY, Bell MJ. Gamekeepers thumb: a prospective study of functional bracing. J Hand Surg Am. 1989 May;14(3):567-73. doi: 10.1016/s0363-5023(89)80026-7.

  PMID: 2738347 BACKGROUND

• Landsman JC, Seitz WH Jr, Froimson AI, Leb RB, Bachner EJ. Splint immobilization of gamekeeper's thumb. Orthopedics. 1995 Dec;18(12):1161-5. doi: 10.3928/0147-7447-19951201-06.

  PMID: 8749294 BACKGROUND

• Samora JB, Harris JD, Griesser MJ, Ruff ME, Awan HM. Outcomes after injury to the thumb ulnar collateral ligament--a systematic review. Clin J Sport Med. 2013 Jul;23(4):247-54. doi: 10.1097/JSM.0b013e318289c6ff.

  PMID: 23615487 BACKGROUND

• Mikhail M, Wormald JCR, Thurley N, Riley N, Dean BJF. Therapeutic interventions for acute complete ruptures of the ulnar collateral ligament of the thumb: a systematic review. F1000Res. 2018 Jun 8;7:714. doi: 10.12688/f1000research.15065.1. eCollection 2018.

  PMID: 30057756 BACKGROUND

• de Haas L, van Hoorn B, van de Lucht V, Schep N, Dijkgraaf M, van Heijl M; MUSCAT Trial Collaborator group. Study protocol for a multicenter non-inferiority randomized controlled trial to assess functional outcomes and cost-effectiveness of a primarily non-operative treatment strategy with cast immobilization versus immediate operative treatment followed by cast immobilization for patients with complete ulnar collateral ligament ruptures, including Stener lesions: MUSCAT study. Trials. 2024 Oct 28;25(1):723. doi: 10.1186/s13063-024-08576-x.

  PMID: 39468632 DERIVED

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

• Mark van Heijl, MD, PhD

  Diakonessenhuis, Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not possible for surgical intervention vs cast immobilization
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 22, 2022
• Study Start: February 17, 2022
• Primary Completion: October 1, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: August 21, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: When the manuscripts are published

Locations

NL (1)