Ulnar Collateral Ligament SprainMUSCATNCT05291260
RCT on Nonoperative Versus Operative Treatment for Acute Complete tearS of the Ulnar Collateral ligAment of the Thumb
A study testing Cast immobilization and Surgical treatment in people with Ulnar Collateral Ligament Sprain and Skier's Thumb, run by Diakonessenhuis, Utrecht at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulnar Collateral Ligament Sprain, Skier's Thumb
- What is being tested?
- Cast immobilization and Surgical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Feb 2022to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
- Being tested
- Cast immobilization, Surgical treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cast immobilizationProcedure or surgery
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).
Surgical treatmentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Cast immobilization |
| Surgery | Active comparator | The intervention is compared to surgery, which is standard treatment for complete ulnar collateral ligament ruptures. Receives: Procedure: Surgical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (12)
Patient-Specific Functional Scale (PSFS)
a self-reported, patient-specific outcome measure, designed to assess functional change, primarily in patients presenting with musculoskeletal disorders. Patients are asked to identify up to five important activities they are unable to perform or are having difficulty with as a result of their problem i.e. putting socks on. In addition to identifying the activities, patients are asked to rate, on an 11-point scale, the current level of difficulty associated with each activity. Following the intervention, patients are asked again to rate the activities previously identified and are given the chance to nominate new problematic activities that might have arisen during that time. "0" represents unable to perform, "10" represents able to perform. Patients select a value that best describes their current level of ability on each activity assessed.
Measured: at randomization, 2, 3, 6 and 12 months after randomization.
EQ-5D-5L
a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ VAS. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale. This can be used as a quantitative measure of health outcome that reflects the patient's own judgment. The score on the five dimensions can be presented as a health profile or can be converted into a utility score based on an available Dutch scoring algorithm (www.euroqol.org). The area under the curve of utility scores over time will be used to express the effect on quality of life in QALY's.
Measured: at randomization, 2, 3, 6 and 12 months after randomization.
Michigan Hand outcome Questionnaire (MHQ)
see above
Measured: at randomization, 2, 3 and 12 months after randomization.
The Numeric Pain Rating Scale (NPRS)
will be used to assess pain, where 0 implies no pain and 10 the worst possible pain measured
Measured: at randomization, 2, 3, 6 and 12 months after randomization.
Patient satisfaction
will be measured by using the ICHOM Satisfaction with treatment results questionnaire (self designed by ICHOM)
Measured: at randomization, 2, 3, 6 and 12 months after randomization.
The adapted Dutch institute for Medical Technology Assessment (iMTA) Medical Consumption Questionnaire (iMCQ)
to measure the amount of medical consumption due to a complete tear of the UCL (the questionnaire is adjusted for this study)
Measured: 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
Range of motion (ROM)
flexion and extension of the metacarpophalangeal (MCP) joint and interphalangeal joint (IP) and palmar abduction of the carpometacarpal (CMC) joint are measured with a goniometer. The first measurement is performed at both sides.
Measured: 4 weeks, 3, 6 and 12 months after randomization.
Kapandji-score
assessing the opposition of the CMC joint. The opposition test consists of touching the four long fingers with the tip of the thumb. The more the tip of the thumb is able to oppose to the base of the pink, the higher the score will be.
Measured: 4 weeks, 3, 6 and 12 months after randomization.
Complications
- Conservative treatment: pressure ulcers, neuropraxia or injury to the sensory superficial branches of radial nerve, arthrosis, chronic instability or limited function.
- Perioperative: vascular damage, nerve or tendon laceration.
- Postoperative: surgical site infection, repeat operation, pressure ulcers, neuropraxia or injury to the sensory superficial branches of radial nerve, arthrosis, chronic instability or limited function.
Peri- and postoperative complications will be recorded according tot the Clavien-Dindo Classification for hand surgery. Repeat operation and subsequent description of the additional treatment method will be reported.
Measured: 4 weeks, 3, 6 and 12 months after randomization.
The adapted Dutch institute for Medical Technology Assessment (iMTA)Productivity Cost Questionnaire (iPCQ)
to measure the amount sick leave from work or lost productivity while at work and out-of pocket expenses due to a complete tear of the UCL and the questionnaire is adjusted for this study.
Measured: 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
Grip strength
measured with a hand-held dynamometer. The measurement includes three trials of maximum grip force using the second handle of a calibrated dynamometer, with the elbow in 90° flexion. Dynamometer settings will be based on patients' hand size. Each center will use the same type of dynamometer. The mean score of three trials will be used for analysis as an absolute measure. The first measurement is performed at both sides.
Measured: 4 weeks, 3, 6 and 12 months after randomization.
Pinch strength
key pinch/lateral pinch and tip pinch will be measured. Key pinch includes three trials of maximum force between the radial side of the index finger and the pulp of the thumb, using a calibrated pinch gauge, with the elbow in 90° flexion. Tip pinch includes three trials of maximum force between the tip of the index finger and the tip of the thumb, using a calibrated pinch gauge, with the elbow in 90° flexion. Each center will use the same type of pinch gauge. The mean score of three trials will be used for analysis as an absolute measure. The first measurement is performed at both sides.
Measured: 4 weeks, 3, 6 and 12 months after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start17 Feb 2022
- Primary completion1 Oct 2025 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Ulnar Collateral Ligament SprainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diakonessenhuis, Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
- Investigators
- Mark van Heijl, MD, PhD, Principal investigator, Diakonessenhuis, Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291260
- Sponsor's protocol ID
- NL78886.100.21
- Acronym
- MUSCAT
- Status last verified
- Sep 2024
- First submitted
- 3 Mar 2022
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: An official Data Management Plan has been developed, in accordance with the official format used in the Netherlands.
Publications
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.
PubMed 28248741Pichora 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.
PubMed 2738347Landsman 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.
PubMed 8749294Samora 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.
PubMed 23615487Mikhail 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.
PubMed 30057756de 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.
PubMed 39468632
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05291260
- Acronym / sponsor ID
- MUSCAT / NL78886.100.21
- Conditions
- Ulnar Collateral Ligament Sprain, Skier's Thumb
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Diakonessenhuis, UtrechtUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 22 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cast immobilization | Experimental | Procedure: Cast immobilizationCast 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. |
| Surgery | Active comparator | Procedure: Surgical treatmentThe intervention is compared to surgery, which is standard treatment for complete ulnar collateral ligament ruptures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cast immobilizationA 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 or surgery | Cast immobilization |
| Surgical treatmentIn 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. | Procedure or surgery | Surgery |
Primary outcome
Michigan Hand outcome Questionnaire (MHQ)
Time frame: 6 months
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).
12 secondary outcomes
Patient-Specific Functional Scale (PSFS)
Time frame: at randomization, 2, 3, 6 and 12 months after randomization.
EQ-5D-5L
Time frame: at randomization, 2, 3, 6 and 12 months after randomization.
Michigan Hand outcome Questionnaire (MHQ)
Time frame: at randomization, 2, 3 and 12 months after randomization.
The Numeric Pain Rating Scale (NPRS)
Time frame: at randomization, 2, 3, 6 and 12 months after randomization.
Patient satisfaction
Time frame: at randomization, 2, 3, 6 and 12 months after randomization.
The adapted Dutch institute for Medical Technology Assessment (iMTA) Medical Consumption Questionnaire (iMCQ)
Time frame: 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
Range of motion (ROM)
Time frame: 4 weeks, 3, 6 and 12 months after randomization.
Kapandji-score
Time frame: 4 weeks, 3, 6 and 12 months after randomization.
Complications
Time frame: 4 weeks, 3, 6 and 12 months after randomization.
The adapted Dutch institute for Medical Technology Assessment (iMTA)Productivity Cost Questionnaire (iPCQ)
Time frame: 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
Grip strength
Time frame: 4 weeks, 3, 6 and 12 months after randomization.
Pinch strength
Time frame: 4 weeks, 3, 6 and 12 months after randomization.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Results publication: PubMed 28248741Pulos 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.
- Results publication: PubMed 2738347Pichora 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.
- Results publication: PubMed 8749294Landsman 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.
- Results publication: PubMed 23615487Samora 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.
- Results publication: PubMed 30057756Mikhail 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.
- Derived from this study: PubMed 39468632de 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.
- Individual participant dataSharing planned: Yes. An official Data Management Plan has been developed, in accordance with the official format used in the Netherlands.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark van Heijl, MD, PhD principal investigator
Diakonessenhuis, Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cast immobilization and Surgical treatment in people with Ulnar Collateral Ligament Sprain and Skier's Thumb, run by Diakonessenhuis, Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Michigan Hand outcome Questionnaire (MHQ) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05291260, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.