Clinical trial NCT05291260: RCT on Nonoperative Versus Operative Treatment for Acute Complete tearS of the Ulnar Collateral ligAment of the Thumb
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ulnar Collateral Ligament Sprain
Skier's Thumb
Lead sponsor: Diakonessenhuis, Utrecht
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2022-03-22
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?


Eligibility 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:

-

Primary outcomes:
measure: Michigan Hand outcome Questionnaire (MHQ)
timeFrame: 6 months
Secondary outcomes:
measure: Patient-Specific Functional Scale (PSFS)
timeFrame: at randomization, 2, 3, 6 and 12 months after randomization.
measure: EQ-5D-5L
timeFrame: at randomization, 2, 3, 6 and 12 months after randomization.
measure: Michigan Hand outcome Questionnaire (MHQ)
timeFrame: at randomization, 2, 3 and 12 months after randomization.
measure: The Numeric Pain Rating Scale (NPRS)
timeFrame: at randomization, 2, 3, 6 and 12 months after randomization.
measure: Patient satisfaction
timeFrame: at randomization, 2, 3, 6 and 12 months after randomization.
measure: The adapted Dutch institute for Medical Technology Assessment (iMTA) Medical Consumption Questionnaire (iMCQ)
timeFrame: at 2 months (over the last 2 months), 3 (over the last month), 6 (over the last 3 months), and 12 (over the last 3 months) months after randomization
measure: Range of motion (ROM)
timeFrame: 4 weeks, 3, 6 and 12 months after randomization.
measure: Kapandji-score
timeFrame: 4 weeks, 3, 6 and 12 months after randomization.
measure: Complications
timeFrame: 4 weeks, 3, 6 and 12 months after randomization.
measure: The adapted Dutch institute for Medical Technology Assessment (iMTA)Productivity Cost Questionnaire (iPCQ)
timeFrame: at 2 months (over the last 2 months), 3 (over the last month), 6 (over the last 3 months), and 12 (over the last 3 months) months after randomization
measure: Grip strength
timeFrame: 4 weeks, 3, 6 and 12 months after randomization.
measure: Pinch strength
timeFrame: 4 weeks, 3, 6 and 12 months after randomization.
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Diakonessenhuis Utrecht
Study officials:
affiliation: Diakonessenhuis, Utrecht
name: Mark van Heijl, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.