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

INTERVENTION: 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. CONDITION: Injuries and Accidents ‐ Other injuries and accidents Mallet Finger Deformity; ; Mallet Finger Deformity Musculoskeletal ‐ Other muscular and skeletal disorders Surgery ‐ Surgical techniques PRIMARY OUTCOME: The primary outcome assessed will be patient satisfaction. This will be assessed at baseline, 8 weeks, 3, 6, and 12‐months. The patient satisfaction survey/questionnaire has been specifically designed for this study. It includes both 11‐point likert scales Over time, the likert scales will be used to compare the difference in patient reported satisfaction between the interventions. ; ; Currently, there is no validated orthopaedic measure of patient satisfaction. [ The outcome will be assessed at 8 weeks, 3 months, 6 months, and 12 months following surgery or application of the splint. ] INCLUSION CRITERIA: ‐ Patients diagnosed with an uncomplicated closed mallet finger: Soft tissue/tendinous mallet deformity, avulsion fracture of the distal phalan Xarticular 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 SECONDARY OUTCOME: Overall hand function assessed using Michigan Hand Questionnaire (MHQ). This examination will be completed by an accredited hand therapist. [ 8 weeks, 3‐, 6‐ and 12‐months post‐treatment] Prospective cost analysis of both interventions. The costs of both interventions will be recorded for later analysis. The operative group will incur more cost initially due to theatre expenses, however, the splint group will require more hand therapy outpatient appointments. The following items are anticipated expenses: consultant/SET surgeon and junior orthopaedic doctors, accredited hand therapist, operating theatre (i.e. hardware, theatre staff, anaesthesia), orthosis‐related expenses, outpatient department appoints for hand therapy and orthopaedics, imaging (x‐ray), and complication related expenses (i.e. antibiotics for infection). The items incurred by each participant will be recorded to compare the expenses generated by each group. [ These will be recorded throughout the duration of the controlled trial. ] The complications observed/reported for both groups will be recorded. This will include those that are patient‐reported and those observed by the research team. [ These will be recorded throughout the duration of the controlled trial. ] The crawford criteria, which consists of extension lag level, DIP flexion and the visual Analogue Scale (VAS) score to evaluate pain. This examination will be completed by an accredited hand therapist.[ 8 weeks, 3‐, 6‐ and 12‐months post‐treatment. ] The EQ‐5D‐5L is a patient reported questionnaire that measure quality of life on a 5‐component scale that incorporates mobility, self‐care, usual activities, pain/discomfort, and anxiety/depression.[ 8 weeks, 3‐, 6‐ and 12‐months post‐treatment] The global rating of change will also be applied to the participants in the patient satisfaction questionnaire. This will be useful to quantify the patient's perceived improvement or deterioration over time in addition to the primary outcome. [ 8 weeks, 3‐, 6‐ and 12‐months post‐treatment] Time out of work assessed using the Disability of Arm, Shoulder and Hand [DASH] questionnaireThis examination will be completed by an accredited hand therapist. [ 8 weeks, 3‐, 6‐ and 12‐months post‐treatment]