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Efficacy of two splint treatment protocols of tendinous mallet finger Injuries

Efficacy of two splint treatment protocols for tendinous mallet finger injuries.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001313426
Enrollment
66
Registered
2016-09-19
Start date
2016-02-17
Completion date
2019-10-11
Last updated
2021-04-12

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

Conditions

None listed

Brief summary

Specialised Hand Therapy Services is conducting research in conjunction with Edith Cowan University into outcomes following treatment of tendinous Mallet finger injuries. The aim is to determine whether long term outcomes can be improved by providing an additional splint to the usual standard splint protocol that is currently used. The project is being conducted by Taryn Post, Jessica Mirabile, Cathy Thomas and staff at Specialised Hand Therapy Services and also with Dr. Janet Richmond from Edith Cowan University. This project will help us find out if positioning the finger differently (i.e. with the PIP joint in flexion as well as the DIP joint in extension/hyperextension) improves results/ outcomes for our clients. We are currently evaluating the protocol and splint type that we use for the treatment of acute tendinous mallet injuries. We are collecting data and evaluating the outcomes to better aid in the protocol that we use in the treatment for these diagnoses. We wish to study whether an additional splint that keeps the PIP (middle) joint of the injured finger in a slightly flexed (bent) position while wearing the splint for the injured DIP (end) joint improves long term outcomes and results with conservative/nonsurgical management of Mallet finger injuries.

Interventions

Current literature supports the conservative management over surgical management for type one tendinous mallet injuries (ie full or partial rupture of the terminal insertion of the extensor tendon in the finger). However the gold standard of conservative treatment is still under development and a topic for debate amongst researchers and clinicians. This study will include two groups: the 'Standard Care Group' will follow the 'standard' tendinous mallet splint protocol of a custom-made thermoplas

Current literature supports the conservative management over surgical management for type one tendinous mallet injuries (ie full or partial rupture of the terminal insertion of the extensor tendon in the finger). However the gold standard of conservative treatment is still under development and a topic for debate amongst researchers and clinicians. This study will include two groups: the 'Standard Care Group' will follow the 'standard' tendinous mallet splint protocol of a custom-made thermoplastic splint including and blocking the DIP joint in extension/hyperextension with the PIP joint free for eight weeks full time wear followed by four weeks of intermittent day wear and nocturnal wear. The 'Standard Care Group' data will be collected retrospectively. The 'PIP protocol group', will wear a custom-made thermoplastic splint which blocks the PIP joint in a controlled flexion range for the initial two-four weeks (determined by the natural laxity of the volar plate and hyperextension of the PIP joint) together with the DIP joint blocked in extension/hyperextension, before continuing with the 'standard' protocol for up to eight weeks of continuous splint wear followed by a further four weeks of protective and nocturnal wear. It is proposed that the 'PIP Protocol Group' data will be followed prospectively. All subjects will be asked at each treatment intervention regarding their adherence to the treatment protocol, and any diversions or changes noted. Proposed methodology: Quantitative methods will be used to compare the outcomes for the two treatment groups. Approximately 30 people will be recruited retrospectively to analyse outcomes of the standard treatment group. Approximately 30 people will be recruited prospectively for the PIP protocol group. Patients with a Zone One tendinous mallet finger injury, who fit the selection criteria and agree to participation in the study, will be allocated to a group – 'Standard care' or 'PIP protocol' care. In the initial phase all patients will be treated using the 'Standard care' group. This phase will continue for a period of three months or until a total of 30 patients is reached and will include retrospective clients who provide consent to access their records. Following completion of this phase, all subsequent patients will be allocated to the 'PIP protocol' group for a period of three months or until a total of 30 patients is reached for this group. The Occupational Therapy staff at Specialised Hand Therapy Service will conduct the standard treatment trial at any of their nine practice locations in Western Australia, with Dr Janet Richmond from ECU School of Medical and Health Sciences taking the chief investigator role. Data analysis will be conducted using SPSS. Correlations of outcomes will be investigated. Standard deviation and t-test statistics will be calculated to determine effect size and significance of the treatment protocol.

Sponsors

Specialised Hand Therapy Services
Lead SponsorOther

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

Inclusion criteria: Only people fitting the following criteria will be recruited: > only people aged 18 to 65 years >Zone One extensor tendon tendinous mallet injuries of the fingers >less than three weeks post injury at the time of the initial assessment

Exclusion criteria

Exclusion criteria: >bony avulsion fracture mallet injuries >aged below 18 or older than 65 years >Previous mallet injury at the same joint > Previous injury to the same finger that may impact outcomes e.g. Swan Neck deformity, fixed flexion deformity, pre-existing reduced range of motion. > laceration or open tendon mallet injuries > surgical repairs >a patient who experienced the injury more than three weeks prior to the initial presentation

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026