Skip to content

Mallet and Extension Relative Motion Splinting Trial

A randomised controlled trial evaluating the effect of adjunctive extension relative motion splints on extensor lag for patients with tendinous closed mallet finger injuries.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620001344987
Acronym
MERMS Trial
Enrollment
64
Registered
2020-12-14
Start date
2021-01-01
Completion date
2022-12-31
Last updated
2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary purpose of this study is to improve the healing of an injury to the extensor tendon of the finger known as ‘mallet finger’ by improved splinting. The disorder is caused by disruption of the extensor tendon to the most distal bone of the finger, resulting in an inability to fully straighten the finger. The current standard care for mallet finger injuries uses a splint that statically immobilises the most distal finger joint (DIPJ) in extension. However, in many patients the tendon heals slightly long, ending up with them losing the ability to fully extend their finger, known as a lag. Therefore, we propose using an additional splint that attaches to the adjacent (uninjured) fingers just beyond the knuckles and lifts the injured finger up slightly, known as an extension relative motion splint (ERMS). This results in the injured finger adopting a slightly flexed posture that relaxes the extensor tendon. We hypothesise that this will result in improved healing of the extensor tendon and therefore a reduced risk of lag. Importantly, the uninjured joints can still be fully straightened whilst wearing the ERMS, to prevent them becoming contracted in one position. This project will randomise around 60 patients to have either one (standard) or two (standard and ERMS) moulded plastic splints. The patients will also be stratified according to whether or not they have a small associated fracture. Splinting will be for eight weeks, with an additional two weeks if there is a lag noted after 8 weeks. The primary outcome will be extensor lag measured at two weeks after ceasing full time splinting. Secondary outcomes will be patient satisfaction, active range of motion (AROM) at the DIPJ, change in AROM at the proximal finger joint, total AROM of the finger, and complications.

Interventions

Brief Name: Extension relative motion splinting of metacarpophalangeal joint of injured finger (additional to standard care control arm) Why: To relax the extensor mechanism of the injured finger, allowing the ruptured terminal tendon ends to heal without tension - in theory this should reduce residual extensor lag at the distal interphalangeal joint What: Orficast extension relative motion splint (ERMS - see attached splinting protocol) Who Provided: Senior hand therapists (as per attached spli

Brief Name: Extension relative motion splinting of metacarpophalangeal joint of injured finger (additional to standard care control arm) Why: To relax the extensor mechanism of the injured finger, allowing the ruptured terminal tendon ends to heal without tension - in theory this should reduce residual extensor lag at the distal interphalangeal joint What: Orficast extension relative motion splint (ERMS - see attached splinting protocol) Who Provided: Senior hand therapists (as per attached splinting protocol) How: In person Where: In a city hospital outpatient setting (2 centres) When and How Much: For 8 weeks continuously (plus additional 2 weeks continuously if an extension lag is present after 8 weeks splinting). Splint is only removed for approximately 5 minutes twice per day to perform hygiene and finger abduction exercises. These exercises will entail fully spreading the fingers and bringing them back together again for 20 repetitions. Tailoring: ERMS is custom made to fit each patient How Well (Planned): Assessment of compliance by hand therapist using standardised method (Groth GN, Wilder DM, Leroy Young V: The Impact of Compliance on the Rehabilitation of Patients with Mallet Finger Injuries. Journal of Hand Therapy 7:21-24, 1994)

Sponsors

Western Sydney Local Health District
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• Closed bony or soft tissue mallet injury of a finger without joint subluxation • Suitable for mallet splint • Suitable for relative motion splint • Extensor lag at presentation greater than 10 degrees (measured by goniometer) • Injury less than or equal to 14 days old

Exclusion criteria

• Patient not able to consent themselves • Previous or current injuries/disease affecting same digit

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026