Post Operative Ankle Splint Study - Prospective Multi Center Randomized Controlled Trial
Condition: Ankle Fractures; Splints
MeSH terms: Ankle Fractures
Study type: Interventional

Summary: 
      Background: Ankle fractures are some of the most common orthopedic presentations, however,
      controversy in their management and their post-operative rehabilitation protocols exist. Most
      displaced ankle fractures treated with anatomical reduction and stable internal fixation to
      allow early range of motion by allowing rigid fixation and restoration of ankle joint
      congruence. Post-operative rehabilitation protocols varies between surgeons and institutions
      with the majority emphasising early rehabilitation protocols. The use of a splint. The
      rational for splinting ankle fractures after rigid fixation is to decrease pain level, rest
      the soft tissues and prevent equinus deformity. Up to date there is no scientific research to
      question the benefit of routine use of splints after rigid fixation of ankle fractures.

      Methods: A prospective multi-centre randomised control trial. Approximately fifty patients
      will be enrolled from 3 hospitals (Adan, Mubarak and Farwaniya hospital) over a 1 year
      period. The studied sample will be randomised into 2 groups using computerised randomisation
      software: splint group and no-splint group. The patients will be examined at set intervals
      for pain, swelling, deep-vein thrombosis and a set of scoring tools. The tools include:
      visual analogue score (VAS) for pain, Short Form Health Survey (SF-36), American Orthopaedic
      Foot and Ankle Society (AOFAS) Ankle-Hindfoot score, physical and radiological assessment at
      2 weeks, 3 months, 6 months and 1 year intervals. Statistical Package for the Social Sciences
      program (SPSS) will be used for statistical analysis

      Results/outcomes: Functional scores, symptoms and signs, complications, radio-graphic and
      clinical follow up will be recorded.
    

Detailed description: 
      Overview

      The mainstay of unstable ankle fractures is surgical in nature, however controversy and an
      unclear consensus exists regarding post-operative rehabilitation; is a splint necessary or
      not? Splinting the ankle post-op is traditionally used to reduce pain and limit motion.
      However, the evidence is unclear and benefits are not well established. Further, splinting
      the ankle in the traditional back-slab is accompanied by complications including; pressure
      sores, skin irritation and deep-vein thrombosis.

      There is incomplete evidence supporting early commencement of weight-bearing and the use of a
      detachable type of immobilization to allow exercise during the immobilization period after
      surgical fixation(1). It is also noteworthy that its believed that because of the potential
      increased risk of adverse events, the patient's compliance with the use of a removable type
      of immobilisation to enable controlled exercise is essential(1). To date there is lacking
      scientific research to question the benefit of routine use of splints after rigid fixation of
      ankle fractures. There is little evidence that any specific rehabilitation program improves
      clinical outcome (2). One study found that active ankle movements in combination with weight
      bearing facilitate and improve the rehabilitation following operation for an ankle fracture
      [3]. A systematic review of 38 controlled trials related to the rehabilitation of ankle
      fractures found that early ambulation post-op may improve ankle range of motion, yet with
      limited quality evidence [3, 6]. . Early performance of ankle exercises following surgical
      fixation improved ankle function and mobility, while decreasing pain, but was associated with
      higher rates of adverse events (e.g. surgical wound complications), although most problems
      were minor(3). Use of a removable immobilization device was necessary for this approach. It
      could be plausible that determent and harm to the patient is being done in the form of
      dermatological adverse effects of splints if there is in fact no benefit to their use. There
      is a clear need to define whether or not a splint is needed for the sake of patient safety
      and comfort postoperatively.

      Research Question/Hypothesis What are the benefits and risks of splinting ankle fractures
      post-op. The investigators believe that there is no considerable benefit to splinting ankle
      fractures after fixation, in fact, splinting may even result in stiffness, cast-associated
      complications and reduced patient satisfaction.

      Objectives and aims

      Overall Objective To critically assess the benefits of splints after rigid fixation of ankle
      fractures.

      Specific Aims

      1- To assess the level of pain between the splint and no-splint groups. 2- To compare the
      range of motion between the splint and no-splint groups. Secondary objectives

        1. To assess patient satisfaction between the splint and no-splint groups.

        2. To assess other complications and radiological finding differences between the splint
           and no-splint groups.

        3. To check the difference in time-to-union between the splint and no-splint groups.

      BACKGROUND AND SIGNIFICANCE

      Ankle fractures

      Over five million ankle injuries occur each year in the United States alone, and the
      incidence of these fractures is approximately 187 fractures per 100,000 people each year (4).
      This figure has been increasing, most probably because of the exponential growth of the
      population and the growing amount of people practising sports(4). Cigarette smoking and a
      high body mass index have been associated with ankle fractures(5, 6). Ankle fractures can be
      categorised into stable and unstable fractures. Isolated malleolar fractures are usually
      stable if they are not displaced but, care should be taken with fractures of the medial
      malleolus. Disturbance of nearby structures often occurs in association with these fractures,
      and they sometimes appear to be isolated injuries at first. Bimalleolar Fractures, which is
      fracture of both the lateral and medial malleoli, are generally unstable. Trimalleolar
      fractures are unstable and typically occur with injuries of greater force. These are
      bimalleolar fractures with a fracture of the posterior malleolus.

      Fracture stability determines treatment. Emergent conditions, such as an open fracture or
      neurovascular impairment, necessitate surgical consultation and treatment. Fracture
      dislocations must be reduced to avoid serious complications, such as avascular necrosis.
      After emergency situations are excluded, the fracture should be evaluated more closely, with
      focus on any malalignment or instability, to determine proper management. Standard treatment
      for stable ankle is Immobilization in a cast (CI) for approximately six weeks but, new
      evidence is growing and supporting that shorter periods of casting allows a similar level of
      healing with less risk of complications. A randomized trial of 247 adults with stable
      fractures of the lateral malleolus, 3 week long immobilization in a short-leg walking cast or
      rigid ankle orthosis reduced the short-term loss of ankle mobility and the risk for deep vein
      thrombosis as compared with care, without compromising fracture healing(4). Confirmation of
      these results is needed, but 3 weeks of immobilization may be a reasonable approach in
      healthy adults with uncomplicated fractures. Unstable ankle fractures are treated surgically.

      Research design and methods

      Overview

      The PASS Trial is going to be a 1-2 year long randomised control trial where a qualified team
      of doctors will administer a questionnaire, take clinical examination results, and assign
      patients to treatment groups of splint and non-splint post-surgical repair. Range of motion
      will be evaluated with a Goniometer and information will be gathered in a standardized
      manner. Patients aged 18-65 taken from Adan, Mubarak, and Farwaniya hospitals will be
      consented and randomly assigned to a treatment group after which they will be followed
      periodically at their designated follow up appointments, which are at 2 weeks, 3 months, 6
      months and 1 year. Patients will be collected over the duration of 2 years until a quota of
      50-75 participants is achieved. Only isolated A.O 44 ankle fractures requiring surgical
      fixation will be included in the study. Pathological fractures, polytrauma patients and open
      fractures will be excluded.

      Strengths and weaknesses of the study

      Study Design

      This study is a double blinded Randomized Control Trial to eliminate as much bias as
      possible. All Principle investigators who measured the results are near equal in terms of
      experience and education. Methods of gathering and collecting data as well as tools to do so
      were standardized. Our study will utilize multivariate regression models and intention to
      treat analysis. The study covers the major trauma centres in Kuwait providing adequate
      representation of the population. Recall bias is minimized due to close proximity of
      questioning and the event.

      Potential Limitations Patient compliance to treatment arms is the main potential issue of our
      study. The extent of non-compliance was measured through questionnaire. There is a lack of
      literature on this subject, which results in deficient comparison with other populations
      around the globe and in the region.

      Public health significance

      On the Individual Level The Patients as individuals will feel liberated as they may no longer
      consider themselves disabled and diseased while they are not wearing a split providing
      physiological relief. This benefit could even translate to earlier return to work and benefit
      society. Individuals will no longer be inconvenienced by being required to wear a splint.

      On The Global Level It is in the interest of public health care systems to conduct this trial
      because there is a possibility that the costs of splints provide by the hospitals will be cut
      and put to better use. Such a trial could impact public health policy because it can provide
      good evidence to change the current standards of care. This study may also reveal
      associations that are possibly good targets for public health intervention. This is
      especially important in our country as there is a locally observed predisposition to injury
      for hard labour and construction workers, so there it is necessity to see if there is an
      association between current working conditions and likeliness of injury.
    

Intervention name(s): Splinting (plaster of paris)
Intervention type(s): Procedure
Intervention description(s): Placing stockinette followed by cotton rolls and 10-12 layer of posterior ankle splint made of plaster of paris
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care