Clinical trial NCT03032653: Immediate Weight-Bearing Ankle Study
Official title: Immediate Unprotected Weight-Bearing and Range of Motion After Open Reduction and Internal Fixation of Unstable Ankle Fractures. A Historical Control Group Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Fractures
Surgery
Keywords: ankle, fracture, rehabilitation, weightbearing, early, late
Lead sponsor: Fraser Orthopaedic Research Society
Sponsor class: NETWORK
First posted: 2017-01-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Olerud and Molander Score
timeFrame: 6 weeks post treatment
Secondary outcomes:
measure: EQ-5D
timeFrame: 2, 6 and 12 weeks post treatment
measure: WPAI:SHP Work Productivity and Activity Impairment Questionnaire: Specific Health Problem
timeFrame: 2, 6 and 12 weeks post treatment
measure: Range of Motion
timeFrame: 2, 6 and 12 weeks post treatment
measure: Wound Healing
timeFrame: 2, 6 and 12 weeks post treatment
measure: Fracture Healing
timeFrame: 2, 6 and 12 weeks post treatment
measure: Need for Re-operation
timeFrame: 2, 6 and 12 weeks post treatment
measure: Time to Return to Work
timeFrame: 2, 6 and 12 weeks post treatment
measure: Radiographic assessment
timeFrame: 2, 6 and 12 weeks post treatment
Other outcomes:
Locations:
city: New Westminster
country: Canada
facility: Royal Columbian Hospital / Fraser Health Authority
state: British Columbia
Study officials:
affiliation: Royal Columbian Hospital / Fraser Health Authority
name: Darius G Viskontas, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Columbian Hospital / Fraser Health Authority
name: Vu (Brian) Le, MD, FRSCS
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Columbian Hospital / Fraser Health Authority
name: Kelly L Apostle, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
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