Study Results
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Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2017-02-09
2021-01-18
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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:
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.
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
Interventions
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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:
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Fraser Orthopaedic Research Society
NETWORK
Responsible Party
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Principal Investigators
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Darius G Viskontas, MD, FRCSC
Role: PRINCIPAL_INVESTIGATOR
Royal Columbian Hospital / Fraser Health Authority
Vu (Brian) Le, MD, FRSCS
Role: PRINCIPAL_INVESTIGATOR
Royal Columbian Hospital / Fraser Health Authority
Kelly L Apostle, MD, FRCSC
Role: PRINCIPAL_INVESTIGATOR
Royal Columbian Hospital / Fraser Health Authority
Locations
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Royal Columbian Hospital / Fraser Health Authority
New Westminster, British Columbia, Canada
Countries
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References
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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.
Other Identifiers
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FHREB #: 2016-101
Identifier Type: -
Identifier Source: org_study_id
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