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Immediate Weight-Bearing Ankle Study

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ClinicalTrials.gov Identifier: NCT03032653
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : April 23, 2021
Sponsor:
Information provided by (Responsible Party):
Fraser Orthopaedic Research Society

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.

Condition or disease Intervention/treatment Phase
Ankle Fractures Surgery Other: Late Rehabilitation Other: Early Rehabilitation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 9, 2017
Actual Primary Completion Date : January 18, 2021
Actual Study Completion Date : January 18, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Late WB
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

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:


Experimental: Immediate unprotected WB and ROM
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
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 Measures :
  1. Olerud and Molander Score [ Time Frame: 6 weeks post treatment ]
    An assessment of symptoms after ankle fracture.


Secondary Outcome Measures :
  1. EQ-5D [ Time Frame: 2, 6 and 12 weeks post treatment ]
    Health Related quality of life outcome measure using five dimensions: Mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

  2. WPAI:SHP Work Productivity and Activity Impairment Questionnaire: Specific Health Problem [ Time Frame: 2, 6 and 12 weeks post treatment ]
    A questionnaire pertaining to the effect of the participant's ankle fracture on their ability to work and perform regular activities.

  3. Range of Motion [ Time Frame: 2, 6 and 12 weeks post treatment ]
    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.

  4. Wound Healing [ Time Frame: 2, 6 and 12 weeks post treatment ]
    Complications regarding the surgical wound, including but not limited to signs of infection or dehiscence.

  5. Fracture Healing [ Time Frame: 2, 6 and 12 weeks post treatment ]
    Radiographic assessment to determine healing, loss of reduction, loss of hardware fixation, or ankle alignment.

  6. Need for Re-operation [ Time Frame: 2, 6 and 12 weeks post treatment ]
    Any issue, whether it be a wound complication or fracture complication, requiring re-operation.

  7. Time to Return to Work [ Time Frame: 2, 6 and 12 weeks post treatment ]
    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.

  8. Radiographic assessment [ Time Frame: 2, 6 and 12 weeks post treatment ]
    Assessment of alignment, hardware fixation, fracture reduction and loss of reduction (defined as any shft of 2mm or more in fracture position)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032653


Locations
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Canada, British Columbia
Royal Columbian Hospital / Fraser Health Authority
New Westminster, British Columbia, Canada, V3L 3M2
Sponsors and Collaborators
Fraser Orthopaedic Research Society
Investigators
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Principal Investigator: Darius G Viskontas, MD, FRCSC Royal Columbian Hospital / Fraser Health Authority
Principal Investigator: Vu (Brian) Le, MD, FRSCS Royal Columbian Hospital / Fraser Health Authority
Principal Investigator: Kelly L Apostle, MD, FRCSC Royal Columbian Hospital / Fraser Health Authority
Publications:

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Responsible Party: Fraser Orthopaedic Research Society
ClinicalTrials.gov Identifier: NCT03032653    
Other Study ID Numbers: FHREB #: 2016-101
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: April 23, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fraser Orthopaedic Research Society:
ankle, fracture, rehabilitation, weightbearing, early, late
Additional relevant MeSH terms:
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Fractures, Bone
Ankle Fractures
Wounds and Injuries