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Immediate Weight-Bearing Ankle Study

Primary Purpose

Ankle Fractures, Surgery

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Late Rehabilitation

Early Rehabilitation

About this trial

This is an interventional treatment trial for Ankle Fractures focused on measuring ankle, fracture, rehabilitation, weightbearing, early, late

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Royal Columbian Hospital / Fraser Health Authority

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Late WB

Immediate unprotected WB and ROM

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Olerud and Molander Score

An assessment of symptoms after ankle fracture.

Secondary Outcome Measures

EQ-5D

Health Related quality of life outcome measure using five dimensions: Mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

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.

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.

Wound Healing

Complications regarding the surgical wound, including but not limited to signs of infection or dehiscence.

Fracture Healing

Radiographic assessment to determine healing, loss of reduction, loss of hardware fixation, or ankle alignment.

Need for Re-operation

Any issue, whether it be a wound complication or fracture complication, requiring re-operation.

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.

Radiographic assessment

Assessment of alignment, hardware fixation, fracture reduction and loss of reduction (defined as any shft of 2mm or more in fracture position)

Full Information

NCT ID

NCT03032653

First Posted

January 24, 2017

Last Updated

April 21, 2021

Sponsor

Fraser Orthopaedic Research Society

1. Study Identification

Unique Protocol Identification Number

NCT03032653

Brief Title

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

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

February 9, 2017 (Actual)

Primary Completion Date

January 18, 2021 (Actual)

Study Completion Date

January 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fraser Orthopaedic Research Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ankle Fractures, Surgery

Keywords

ankle, fracture, rehabilitation, weightbearing, early, late

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Late WB

Arm Type

Active Comparator

Arm Description

Arm Title

Immediate unprotected WB and ROM

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Late Rehabilitation

Intervention Description

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:

Intervention Type

Other

Intervention Name(s)

Early Rehabilitation

Intervention Description

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

Primary Outcome Measure Information:

Title

Olerud and Molander Score

Description

An assessment of symptoms after ankle fracture.

Time Frame

6 weeks post treatment

Secondary Outcome Measure Information:

Title

EQ-5D

Description

Health Related quality of life outcome measure using five dimensions: Mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

Time Frame