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Comparing two different interventions for treatment of volar plate injuries.

A randomised clinical trial comparing outcomes of a single digit volar plate injury. Buddy loops versus dorsal thermoplastic orthosis (Eaton Type I, II, IIIA)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622001425785
Enrollment
64
Registered
2022-11-08
Start date
2022-11-21
Completion date
2024-05-20
Last updated
2022-11-14

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

Conditions

None listed

Brief summary

This study plans to determine if splinting in a neutral (straight) position of more effective than buddy loops in preventing reduced extension (straightening) at the proximal interphalangeal joint (middle joint of the finger). Specific hypotheses will address; splinting the PIPJ in a neutral position produces a) a lower average extension contracture of FFD than splinting in buddy loops; b) lower mean pain scores than buddy loops; c) lower mean oedema measure than buddy loops; and d) splinting the PIPJ in a neutral position results in changed Participants will be randomly assigned to one group and both will commence active exercises within the splint or buddy loop. Both interventions will be worn full-time for 3 weeks and then discharged at 5 weeks. Each participant will be treated and assessed by experienced hand therapists (occupational therapists or physiotherapists) and the assessing therapist will be blinded to the treatment group of there participants. Assessment will be undertaken at their initial presentation, weeks' 3, 5 and 8.

Interventions

Group 1 will receive their initial treatment within in 14 days of sustaining their injury and will be treated in a dorsal blocking orthosis in a neutral position, full-time and commence Active Range of Motion (AROM) within the orthosis. This will involve isolated distal interphalangeal joint flexion/extension exercises, proximal interphalangeal joint flexion/extension exercises and composite flexion/extension exercises and will be asked to be completed 10 repetitions, 6 times per day. Patients

Group 1 will receive their initial treatment within in 14 days of sustaining their injury and will be treated in a dorsal blocking orthosis in a neutral position, full-time and commence Active Range of Motion (AROM) within the orthosis. This will involve isolated distal interphalangeal joint flexion/extension exercises, proximal interphalangeal joint flexion/extension exercises and composite flexion/extension exercises and will be asked to be completed 10 repetitions, 6 times per day. Patients will be shown how to complete these exercises at their initial treatment session and will be asked to complete them at home and will be reviewed and assessed at the treatment sessions by the treating hand therapist. The initial treatment session is anticipated to take approximately 45 minutes for treatment and 30 mins for assessment. The orthosis will be weaned if clinically appropriate at week 3 (post intervention), where by the patient will need to continue to wear it for sleeping and 'at risk' situations/activities. If clinically appropriate the orthosis will be discharged at week 5 (post intervention). Patient will be asked how often they are completing their exercises at each assessment point and a questionnaire will be completed at the 3 week assessment (3 post intervention) to assess adherence to treatment, including splinting. Subsequent treatment sessions are anticipated to take approximately 30 minutes for treatment and 30 minutes for assessment.

Sponsors

Sydney Hospital and Sydney Eye Hospital
Lead SponsorHospital

Study design

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

Eligibility

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

Inclusion criteria

Closed volar plate injury (Eaton type I, II or IIIa) Initial treatment within 14 days of injury Does not require surgery Adequate cognitive functioning Can give informed consent

Exclusion criteria

Concomitant tendon, nerve vascular or bony injury Open injury Previous injury/condition affecting range of motion in the same or contralateral digit

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 10, 2026