Immediate Weight-Bearing Ankle Study

NCT03032653 | Completed

• 1 other identifier: FHREB #: 2016-101
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Fractures; Surgery

Keywords

ankle, fracture, rehabilitation, weightbearing, early, late

Outcome Measures

Primary Outcomes (1)

• Olerud and Molander Score

  An assessment of symptoms after ankle fracture.

  6 weeks post treatment

Secondary Outcomes (8)

• EQ-5D

  2, 6 and 12 weeks post treatment

• WPAI:SHP Work Productivity and Activity Impairment Questionnaire: Specific Health Problem

  2, 6 and 12 weeks post treatment

• Range of Motion

  2, 6 and 12 weeks post treatment

• Wound Healing

  2, 6 and 12 weeks post treatment

• Fracture Healing

  2, 6 and 12 weeks post treatment

Study Arms (2)

Late WB

ACTIVE COMPARATOR

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

Immediate unprotected WB and ROM

EXPERIMENTAL

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

Interventions

Late Rehabilitation OTHER

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:

Late WB

Early Rehabilitation OTHER

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

Immediate unprotected WB and ROM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)
• A1 (Weber A)
• A2 (Bimalleolar)
• A3 (posterior malleolus involvement - but only if \< 25% articular involvement on lateral x-ray)
• B1 (Isolated)
• B2 (with medial lesion)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fraser Orthopaedic Research Society: lead

Study Sites (1)

Royal Columbian Hospital / Fraser Health Authority

New Westminster, British Columbia, V3L 3M2, Canada

Location

Related Publications (16)

• 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.

  PMID: 16814787 BACKGROUND

• 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.

  PMID: 23454858 BACKGROUND

• 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.

  PMID: 16891946 BACKGROUND

• 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.

  PMID: 17485995 BACKGROUND

• 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.

  PMID: 27045369 BACKGROUND

• 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.

  PMID: 17715727 BACKGROUND

• 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.

  PMID: 8168314 BACKGROUND

• 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.

  PMID: 12571295 BACKGROUND

• 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.

  PMID: 17195934 BACKGROUND

• 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.

  PMID: 8636173 BACKGROUND

• 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.

  PMID: 8451961 BACKGROUND

• 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.

  PMID: 2492286 BACKGROUND

• 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.

  PMID: 2044269 BACKGROUND

• 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.

  PMID: 8131334 BACKGROUND

• 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.

  PMID: 10755435 BACKGROUND

• 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.

  PMID: 25695796 BACKGROUND

MeSH Terms

Conditions

Ankle Fractures; Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries; Ankle Injuries; Leg Injuries

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2017
• First Posted: January 26, 2017
• Study Start: February 9, 2017
• Primary Completion: January 18, 2021
• Study Completion: January 18, 2021
• Last Updated: April 23, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)