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Comparison of longitudinal K-wire immobilisation verses custom thermoplastic orthosis for uncomplicated mallet finger deformity: A randomised controlled trial

Comparison of longitudinal K-wire immobilisation verses custom thermoplastic orthosis for uncomplicated mallet finger deformity: A randomised controlled trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623001010684
Enrollment
158
Registered
2023-09-18
Start date
2024-01-01
Completion date
2025-12-12
Last updated
2023-09-26

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

Conditions

None listed

Brief summary

Mallet finger deformity is a common injury to the extensor tendon of the fingers. Currently, there are no published randomised clinical trials comparing operative and non-operative management of this condition. Traditionally, non-operative management has been considered the ‘gold standard’ treatment for uncomplicated mallet finger deformity. However, recent studies have suggested superior patient outcomes regarding compliance amongst patients, patient satisfaction, incidence of skin complications, time out of work and treatment outcomes in the operative management group. Therefore, this randomised clinical trial is required to identify which treatment path is optimal following mallet injury.

Interventions

Group 1: Percutaneous Longitudinal K-wire Immobilisation Longitudinal K-wire immobilisation involves placement of a K-wire from the fingertip, retrograde across the distal interphalangeal joint (DIPJ). The surgery can be completed as a procedure under digital block anaesthesia or under general anaesthesia. The pin will be placed into at least 50% of the length of the medullary canal of the middle phalanx. This mitigates the risk of pin migration. The pin is cut below the skin and the percutaneou

Group 1: Percutaneous Longitudinal K-wire Immobilisation Longitudinal K-wire immobilisation involves placement of a K-wire from the fingertip, retrograde across the distal interphalangeal joint (DIPJ). The surgery can be completed as a procedure under digital block anaesthesia or under general anaesthesia. The pin will be placed into at least 50% of the length of the medullary canal of the middle phalanx. This mitigates the risk of pin migration. The pin is cut below the skin and the percutaneous incision is closed with a quick-acting skin adhesive. The pin will be removed in theatre at 8 weeks. The surgery is anticipated to take 30-60 minutes. Operative intervention must be performed by consultant surgeons, or by fellows or SET-accredited registrars following discussion of the operative plan with the supervising consultant.

Sponsors

Gold Coast University Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

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

Inclusion criteria

- Patients diagnosed with an uncomplicated closed mallet finger: Soft tissue/tendinous mallet deformity, avulsion fracture of the distal phalanx articular surface that involves less than 1/3 the total articular surface, absence of volar joint subluxation - Patients assessed on radiographs [confirmed by Consultant Surgeon] - Aged over 18 years - Able to provide informed consent

Exclusion criteria

- Associated significant soft tissue injury (including open/tendon damage) - Pathological fracture - Presentation >3 weeks - Unable to comply with the assessment requirements or rehabilitation. - Fracture best managed by only one of the included intervention options, or another option, as decided by the Consultant Surgeon

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026