Immediate Weight-Bearing Ankle Study

Study Overview
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Brief Summary
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This single-centre historical control group comparative study will compare outcomes of surgically-treated rotational ankle fractures and the current routine practice of early protected weightbearing and range of motion with immediate unprotected weightbearing as tolerated and range of motion after ankle open reduction and internal fixation.

Detailed Description
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Ankle fractures are among the most common injuries, making up 9% of all fractures. Rotational ankle fractures are among the most common of all fractures, with an incidence averaging 4.2 per 1,000 individuals annually. These fractures range from minimal injuries amenable to non-surgical management to complex injuries with potential of long-term sequelae. Known risk factors for ankle fractures are age, body mass index and previous ankle fracture, with the highest incidence in elderly women. Most ankle fractures are low-energy injuries which occur when the body rotates about a planted foot, whether it be during sports, normal gait, or otherwise. Stable ankle fractures are generally treated non-surgically, while unstable fractures are usually treated with surgical reduction and fixation, with indications previously well-described and published. However, the post-operative management of such injuries is still controversial, with large variability between care providers. Protocols range from complete immobilization of the affected ankle and non-weightbearing to early range-of-motion (ROM) and weightbearing (WB). Studies have compared immobilization and non-WB to early ROM and WB but results have been mixed, with the most recent study demonstrating safety and advantages to protected WB and ROM at two weeks post-operatively versus non-WB and immobilization for six weeks. The Investigators intend to expand on the studies above and propose a single-centre historical control group comparative study to compare outcomes of surgically-treated rotational ankle fractures and the current routine practice of early protected weightbearing and range of motion with immediate unprotected weightbearing as tolerated and range of motion after ankle open reduction and internal fixation.

Official Title
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Immediate Unprotected Weight-Bearing and Range of Motion After Open Reduction and Internal Fixation of Unstable Ankle Fractures. A Historical Control Group Comparative Study

Conditions
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Surgery, Ankle Fractures

Intervention / Treatment
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* Other: Late Rehabilitation
* Other: Early Rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: lateral malleolus fracture with talar shaft vertical shear medial malleolus fracture without superior articular involvement bimalleolar fracture any ankle fracture with posterior malleolus fragment involving 25% or less of the articular surface on the lateral ankle radiograph 43.B1 (pure split of distal tibia - but only if does not involve any of tibial plafond, i.e., only the vertical split of medial malleolus) 44.A1 (Weber A) 44.A2 (Bimalleolar) 44.A3 (posterior malleolus involvement - but only if < 25% articular involvement on lateral x-ray) 44-B1 (Isolated) 44.B2 (with medial lesion) 44.B3 (with medial lesion & Volkmann's #) closed, Gustilo-Anderson Grade I or Grade II open fractures are included willing and able to sign the consent willing and able to follow the protocol and attend follow-up visits able to read and understand English or have an interpreter available Exclusion Criteria: skeletal immaturity demonstrated radiographically by open physes previous ipsilateral ankle surgery bilateral ankle fractures non ambulatory prior to injury inability to comply with postoperative protocol (i.e., cognitive impairment) medical comorbidity precluding surgery poorly controlled diabetes (i.e. dense neuropathy / hx of ulcers / sensory deficit) polytrauma patients (other injuries involving the ipsi/contralateral lower limbs, including the hip, that would interfere with mobilization/rehabilitation) surgical date > 14 days (time of injury to OR) Gustilo-Anderson grade III open fractures tibial plafond fractures active infection at the surgical site diagnosed clinically by the attending surgeon any ankle fracture with posterior malleolus fragment involving more than 25% of the articular surface on the lateral ankle radiograph any medial malleolus fracture involving the superior articular surface any ankle fracture requiring syndesmosis fixation any ankle fracture-dislocation incarceration likely problems, in the judgment of the investigator, with maintaining follow-up

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Late WB<br>Intervention: Patients receive a plaster splint in the operating room. They are not permitted to WB or ROM on the affected limb at this stage. At the first follow-up appointment (two weeks post-op), the splint is removed and a removable pre-fabricated walking boot applied. At this stage the patient is permitted to WB as tolerated while wearing the boot, and to perform ROM exercises with the boot removed. At six weeks post-op, the boot is discontinued and full unrestricted and unprotected weightbearing and ROM is permitted. | Other: Late Rehabilitation<br>* Post-0p: Non weight-bearing and no range of motion for 2 weeks post treatment. 2 weeks: Splint removed, removable pre-fabricated walking boot applied. WB as tolerated with boot, range of motion out of boot. 6 weeks: Boot discontinued and full unrestricted and unprotected WB and ROM permitted 6 weeks:<br>|
| Experimental: Immediate unprotected WB and ROM<br>Patient do NOT receive a brace or splint of any kind. They are permitted to weightbear and range of motion as tolerated within the limitations of their own comfort. Use of ambulatory aids of any kind is permitted as needed without restrictions. | Other: Early Rehabilitation<br>* Weightbearing and range of motion as tolerated within the limitations of participant's own comfort. Use of ambulatory aides of any kind is permitted as needed without restriction. No brace or splint of any kind is permitted<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Olerud and Molander Score | An assessment of symptoms after ankle fracture. | 6 weeks post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EQ-5D | Health Related quality of life outcome measure using five dimensions: Mobility, self-care, usual activities, pain/discomfort and anxiety/depression. | 2, 6 and 12 weeks post treatment | 
| WPAI:SHP Work Productivity and Activity Impairment Questionnaire: Specific Health Problem | A questionnaire pertaining to the effect of the participant's ankle fracture on their ability to work and perform regular activities. | 2, 6 and 12 weeks post treatment | 
| Range of Motion | Amount of ankle dorsiflexion and plantarflexion (measured in degrees) as determined by goniometer assessment, as well as total arc of ankle ROM (dorsiflexion+ plantarflexion). This will be measured on both ankles for comparison. | 2, 6 and 12 weeks post treatment | 
| Wound Healing | Complications regarding the surgical wound, including but not limited to signs of infection or dehiscence. | 2, 6 and 12 weeks post treatment | 
| Fracture Healing | Radiographic assessment to determine healing, loss of reduction, loss of hardware fixation, or ankle alignment. | 2, 6 and 12 weeks post treatment | 
| Need for Re-operation | Any issue, whether it be a wound complication or fracture complication, requiring re-operation. | 2, 6 and 12 weeks post treatment | 
| Time to Return to Work | The chronological time between the date of surgery to the first day the participant returned to occupational duties, if currently employed and returns to work within the 12 weeks postoperative follow-up period. For the purposes of this study, students enrolled in educational activities will have their schooling treated as their occupational duty. | 2, 6 and 12 weeks post treatment | 
| Radiographic assessment | Assessment of alignment, hardware fixation, fracture reduction and loss of reduction (defined as any shft of 2mm or more in fracture position) | 2, 6 and 12 weeks post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ankle, fracture, rehabilitation, weightbearing, early, late