Immediate Weight-Bearing Ankle Study

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

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Ankle Fractures
• Intervention / Treatment: Other: Late Rehabilitation; Other: Early Rehabilitation

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • New Westminster, British Columbia, Canada, V3L 3M2
      • Royal Columbian Hospital / Fraser Health Authority

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fraser Orthopaedic Research Society
• Investigators: 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 and helpful links

General Publications

• Court-Brown CM, Caesar B. Epidemiology of adult fractures: A review. Injury. 2006 Aug;37(8):691-7. doi: 10.1016/j.injury.2006.04.130. Epub 2006 Jun 30.
• Hoelsbrekken SE, Kaul-Jensen K, Morch T, Vika H, Clementsen T, Paulsrud O, Petursson G, Stiris M, Stromsoe K. Nonoperative treatment of the medial malleolus in bimalleolar and trimalleolar ankle fractures: a randomized controlled trial. J Orthop Trauma. 2013 Nov;27(11):633-7. doi: 10.1097/BOT.0b013e31828e1bb7.
• Petrisor BA, Poolman R, Koval K, Tornetta P 3rd, Bhandari M; Evidence-Based Orthopaedic Trauma Working Group. Management of displaced ankle fractures. J Orthop Trauma. 2006 Jul;20(7):515-8. doi: 10.1097/00005131-200608000-00012.
• Michelson JD, Magid D, McHale K. Clinical utility of a stability-based ankle fracture classification system. J Orthop Trauma. 2007 May;21(5):307-15. doi: 10.1097/BOT.0b013e318059aea3.
• Dehghan N, McKee MD, Jenkinson RJ, Schemitsch EH, Stas V, Nauth A, Hall JA, Stephen DJ, Kreder HJ. Early Weightbearing and Range of Motion Versus Non-Weightbearing and Immobilization After Open Reduction and Internal Fixation of Unstable Ankle Fractures: A Randomized Controlled Trial. J Orthop Trauma. 2016 Jul;30(7):345-52. doi: 10.1097/BOT.0000000000000572.
• Gul A, Batra S, Mehmood S, Gillham N. Immediate unprotected weight-bearing of operatively treated ankle fractures. Acta Orthop Belg. 2007 Jun;73(3):360-5.
• O'Sullivan ME, Bronk JT, Chao EY, Kelly PJ. Experimental study of the effect of weight bearing on fracture healing in the canine tibia. Clin Orthop Relat Res. 1994 May;(302):273-83.
• Lehtonen H, Jarvinen TL, Honkonen S, Nyman M, Vihtonen K, Jarvinen M. Use of a cast compared with a functional ankle brace after operative treatment of an ankle fracture. A prospective, randomized study. J Bone Joint Surg Am. 2003 Feb;85(2):205-11. doi: 10.2106/00004623-200302000-00004.
• Honigmann P, Goldhahn S, Rosenkranz J, Audige L, Geissmann D, Babst R. Aftertreatment of malleolar fractures following ORIF -- functional compared to protected functional in a vacuum-stabilized orthesis: a randomized controlled trial. Arch Orthop Trauma Surg. 2007 Apr;127(3):195-203. doi: 10.1007/s00402-006-0255-x. Epub 2006 Dec 30.
• van Laarhoven CJ, Meeuwis JD, van der WerkenC. Postoperative treatment of internally fixed ankle fractures: a prospective randomised study. J Bone Joint Surg Br. 1996 May;78(3):395-9.
• Ahl T, Dalen N, Lundberg A, Bylund C. Early mobilization of operated on ankle fractures. Prospective, controlled study of 40 bimalleolar cases. Acta Orthop Scand. 1993 Feb;64(1):95-9. doi: 10.3109/17453679308994541.
• Finsen V, Saetermo R, Kibsgaard L, Farran K, Engebretsen L, Bolz KD, Benum P. Early postoperative weight-bearing and muscle activity in patients who have a fracture of the ankle. J Bone Joint Surg Am. 1989 Jan;71(1):23-7.
• Cimino W, Ichtertz D, Slabaugh P. Early mobilization of ankle fractures after open reduction and internal fixation. Clin Orthop Relat Res. 1991 Jun;(267):152-6.
• Hedstrom M, Ahl T, Dalen N. Early postoperative ankle exercise. A study of postoperative lateral malleolar fractures. Clin Orthop Relat Res. 1994 Mar;(300):193-6.
• Egol KA, Dolan R, Koval KJ. Functional outcome of surgery for fractures of the ankle. A prospective, randomised comparison of management in a cast or a functional brace. J Bone Joint Surg Br. 2000 Mar;82(2):246-9.
• Smeeing DP, Houwert RM, Briet JP, Kelder JC, Segers MJ, Verleisdonk EJ, Leenen LP, Hietbrink F. Weight-bearing and mobilization in the postoperative care of ankle fractures: a systematic review and meta-analysis of randomized controlled trials and cohort studies. PLoS One. 2015 Feb 19;10(2):e0118320. doi: 10.1371/journal.pone.0118320. eCollection 2015.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 9, 2017
• Primary Completion (ACTUAL): January 18, 2021
• Study Completion (ACTUAL): January 18, 2021

Study Registration Dates

• First Submitted: January 24, 2017
• First Submitted That Met QC Criteria: January 24, 2017
• First Posted (ESTIMATE): January 26, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 23, 2021
• Last Update Submitted That Met QC Criteria: April 21, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: ankle, fracture, rehabilitation, weightbearing, early, late
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Ankle Fractures
• Other Study ID Numbers: FHREB #: 2016-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No