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Early Weightbearing and Mobilization Versus Non-Weightbearing and Mobilization in Unstable Ankle Fractures

Primary Purpose

Ankle Injuries

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Early weight-bearing and range of motion exercises
non-weight bearing, no range of motion
Sponsored by
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Injuries focused on measuring Ankle fracture, Return to work, Return to function, Rehabilitation, Weight-bearing

Eligibility Criteria

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

Inclusion Criteria:

  • Unilateral unstable ankle fracture requiring surgical stabilization
  • Treatment within two weeks of injury
  • Closed or low grade open ankle fracture (grade 1 and/or 2)
  • Skeletally mature

Exclusion Criteria:

  • Skeletally immature
  • Previous ipsilateral ankle surgery
  • Bilateral ankle fractures or other major injuries that would affect recovery time
  • Grade 3 open fractures
  • Inability to co-operate with post-op protocol (advanced dementia, polytrauma patient)
  • Non-ambulatory pre injury
  • Tibial plafond fractures including articular impaction requiring elevation
  • Syndesmosis injury requiring fixation
  • Posterior Malleolus fracture - more than 25% of articular surface

Sites / Locations

  • Sunnybrook Health Sciences CentreRecruiting
  • St. Michael's HopspitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Non-weightbearing no ROM

Early weight-bearing and ROM

Arm Description

Patients will be placed in a back slab post-op and will remain non-weight bearing with crutches with no range of motion for a total of 6 weeks. After 6 weeks post-op, they will be placed in a boot orthosis and permitted to weight-bear as tolerated.

Patients will be placed in a back slab post-operatively. At 2 weeks post op they will have the back slab removed and placed in a boot orthosis. At this time they will be permitted to weight-bear as tolerated and perform limited ankle range of motion exercises. After 6 weeks post op they will start to wean from the boot orthosis.

Outcomes

Primary Outcome Measures

Return to work
Does early weightbearing and ankle range of motion post open reduction internal fixation for unstable ankle fractures improve the rate of return to work compared to traditional post-op ankle immobilization in a non-weightbearing cast?

Secondary Outcome Measures

Functional outcome and event rate
Does early weightbearing and ankle range of motion post open reduction internal fixation for unstable ankle fractures improve the rate of return to work, functional outcome and rate of adverse events compared to traditional post-op ankle immobilization in a non-weightbearing cast?
Functional outcome and event rate
Does early weightbearing and ankle range of motion post open reduction internal fixation for unstable ankle fractures improve the rate of return to work, functional outcome and rate of adverse events compared to traditional post-op ankle immobilization in a non-weightbearing cast?
Return to work and functional outcome
Does early weightbearing and ankle range of motion post open reduction internal fixation for unstable ankle fractures improve the rate of return to work, functional outcome and rate of adverse events compared to traditional post-op ankle immobilization in a non-weightbearing cast?
Return to work and functional outcome
Does early weightbearing and ankle range of motion post open reduction internal fixation for unstable ankle fractures improve the rate of return to work, functional outcome and rate of adverse events compared to traditional post-op ankle immobilization in a non-weightbearing cast?
Return to work and functional outcome
Does early weightbearing and ankle range of motion post open reduction internal fixation for unstable ankle fractures improve the rate of return to work, functional outcome and rate of adverse events compared to traditional post-op ankle immobilization in a non-weightbearing cast?

Full Information

First Posted
September 1, 2010
Last Updated
June 9, 2011
Sponsor
University of Toronto
Collaborators
Orthopaedic Trauma Association, Canadian Orthopaedic Foundation, Künzli SwissSchuh
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1. Study Identification

Unique Protocol Identification Number
NCT01196338
Brief Title
Early Weightbearing and Mobilization Versus Non-Weightbearing and Mobilization in Unstable Ankle Fractures
Official Title
Early Weightbearing and Mobilization Versus Non-Weightbearing and Immobilization After ORIF of Unstable Ankle Fractures: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
June 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Toronto
Collaborators
Orthopaedic Trauma Association, Canadian Orthopaedic Foundation, Künzli SwissSchuh

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of the investigators randomized controlled trial is to determine if early protected weightbearing and ankle range of motion after surgical treatment (open reduction internal fixation - ORIF) for ankle fractures improves the rate of return to work and functional outcome compared to postoperative ankle immobilization in a non-weightbearing cast.
Detailed Description
This is a randomized controlled trial comparing early weightbearing and mobilization VS immobilization and non-weightbearing after initial treatment of unstable ankle fractures. The primary objective of our randomized control trial is to determine if early protected weightbearing and ankle range of motion post open reduction internal fixation (ORIF) for unstable ankle fractures improves the rate of return to work and functional outcome compared to postoperative ankle immobilization in a non-weightbearing cast. Our secondary objective is to determine the rate of adverse events (wound healing, infection, hardware failure) with early weightbearing and ROM comparable to rates with traditional post-op ankle immobilization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Injuries
Keywords
Ankle fracture, Return to work, Return to function, Rehabilitation, Weight-bearing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non-weightbearing no ROM
Arm Type
Active Comparator
Arm Description
Patients will be placed in a back slab post-op and will remain non-weight bearing with crutches with no range of motion for a total of 6 weeks. After 6 weeks post-op, they will be placed in a boot orthosis and permitted to weight-bear as tolerated.
Arm Title
Early weight-bearing and ROM
Arm Type
Experimental
Arm Description
Patients will be placed in a back slab post-operatively. At 2 weeks post op they will have the back slab removed and placed in a boot orthosis. At this time they will be permitted to weight-bear as tolerated and perform limited ankle range of motion exercises. After 6 weeks post op they will start to wean from the boot orthosis.
Intervention Type
Behavioral
Intervention Name(s)
Early weight-bearing and range of motion exercises
Intervention Description
0 weeks to 2 weeks: Posterior plaster slab or cast, non-weightbearing, crutches; At 2 week visit to clinic: Posterior plaster slab or cast removed, staples/stitches removed placed in orthosis, with instructions to be weightbearing as tolerated. Instructions for limited range of motion to be given; At 2 weeks to 6 weeks: Weightbearing as tolerated in orthosis, follow range of motion instructions; After 6 weeks: Instructions to continue weightbearing as tolerated, wean from orthosis.
Intervention Type
Behavioral
Intervention Name(s)
non-weight bearing, no range of motion
Intervention Description
0 weeks to 2 weeks: Posterior plaster slab or cast, non-weightbearing, crutches; At 2 week visit to clinic: Posterior plaster slab or cast removed, staples/stitches removed, BK fibreglass cast or other orthosis applied, with instructions to continue non-weightbearing; At 2 weeks to 6 weeks: Ankle remains immobile and non-weightbearing; After 6 weeks: Begin weightbearing as tolerated. Instructions for limited range of motion to be given, and wean from orthosis.
Primary Outcome Measure Information:
Title
Return to work
Description
Does early weightbearing and ankle range of motion post open reduction internal fixation for unstable ankle fractures improve the rate of return to work compared to traditional post-op ankle immobilization in a non-weightbearing cast?
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Functional outcome and event rate
Description
Does early weightbearing and ankle range of motion post open reduction internal fixation for unstable ankle fractures improve the rate of return to work, functional outcome and rate of adverse events compared to traditional post-op ankle immobilization in a non-weightbearing cast?
Time Frame
2 weeks
Title
Functional outcome and event rate
Description
Does early weightbearing and ankle range of motion post open reduction internal fixation for unstable ankle fractures improve the rate of return to work, functional outcome and rate of adverse events compared to traditional post-op ankle immobilization in a non-weightbearing cast?
Time Frame
6 weeks
Title
Return to work and functional outcome
Description
Does early weightbearing and ankle range of motion post open reduction internal fixation for unstable ankle fractures improve the rate of return to work, functional outcome and rate of adverse events compared to traditional post-op ankle immobilization in a non-weightbearing cast?
Time Frame
9 weeks
Title
Return to work and functional outcome
Description
Does early weightbearing and ankle range of motion post open reduction internal fixation for unstable ankle fractures improve the rate of return to work, functional outcome and rate of adverse events compared to traditional post-op ankle immobilization in a non-weightbearing cast?
Time Frame
6 months
Title
Return to work and functional outcome
Description
Does early weightbearing and ankle range of motion post open reduction internal fixation for unstable ankle fractures improve the rate of return to work, functional outcome and rate of adverse events compared to traditional post-op ankle immobilization in a non-weightbearing cast?
Time Frame
12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Unilateral unstable ankle fracture requiring surgical stabilization Treatment within two weeks of injury Closed or low grade open ankle fracture (grade 1 and/or 2) Skeletally mature Exclusion Criteria: Skeletally immature Previous ipsilateral ankle surgery Bilateral ankle fractures or other major injuries that would affect recovery time Grade 3 open fractures Inability to co-operate with post-op protocol (advanced dementia, polytrauma patient) Non-ambulatory pre injury Tibial plafond fractures including articular impaction requiring elevation Syndesmosis injury requiring fixation Posterior Malleolus fracture - more than 25% of articular surface
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richard Jenkinson, MD, FRCS(C)
Phone
416-480-6100
Ext
7052
Email
richard.jenkinson@sunnybrook.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Hans Kreder, MD,MPH,FRCSC
Phone
416-480-6100
Ext
6816
Email
hans.kreder@sunnybrook.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Jenkinson, MD, FRCSC
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hans Kreder, MD,MPH,FRCSC
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Study Chair
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Jenkinson, MD, FRCSC
Phone
416-480-6100
Ext
7052
Email
richard.jenkinson@sunnybrook.ca
First Name & Middle Initial & Last Name & Degree
Hans Kreder, MD,MPH,FRCSC
Phone
416-480-6100
Ext
6816
Email
hans.kreder@sunnybrook.ca
First Name & Middle Initial & Last Name & Degree
Richard Jenkinson, MD, FRCS(C)
First Name & Middle Initial & Last Name & Degree
Hans Kreder, MD,MPH,FRCSC
First Name & Middle Initial & Last Name & Degree
Niloofar Dehghan, MD
First Name & Middle Initial & Last Name & Degree
Venessa Stas, MD, FRCS(C)
Facility Name
St. Michael's Hopspital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niloofar Dehghan, BSc, MD
Phone
416-997-8735
Email
niloofar.dehghan@utoronto.ca
First Name & Middle Initial & Last Name & Degree
Michael McKee, MD, FRCSC
Phone
416-864-5880
Email
mckeem@smh.ca
First Name & Middle Initial & Last Name & Degree
Michael Mckee, MD, FRCSC

12. IPD Sharing Statement

Citations:
PubMed Identifier
8451961
Citation
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.
Results Reference
background
PubMed Identifier
2502344
Citation
Ahl T, Dalen N, Selvik G. Ankle fractures. A clinical and roentgenographic stereophotogrammetric study. Clin Orthop Relat Res. 1989 Aug;(245):246-55.
Results Reference
background
PubMed Identifier
2044269
Citation
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.
Results Reference
background
PubMed Identifier
17715727
Citation
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.
Results Reference
background
PubMed Identifier
10755435
Citation
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.
Results Reference
background
PubMed Identifier
17195934
Citation
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.
Results Reference
background
PubMed Identifier
12571295
Citation
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.
Results Reference
background
PubMed Identifier
18646131
Citation
Lin CW, Moseley AM, Refshauge KM. Rehabilitation for ankle fractures in adults. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD005595. doi: 10.1002/14651858.CD005595.pub2.
Results Reference
background
PubMed Identifier
18096062
Citation
Nilsson G, Jonsson K, Ekdahl C, Eneroth M. Outcome and quality of life after surgically treated ankle fractures in patients 65 years or older. BMC Musculoskelet Disord. 2007 Dec 20;8:127. doi: 10.1186/1471-2474-8-127.
Results Reference
background
PubMed Identifier
17323637
Citation
Obremskey WT, Brown O, Driver R, Dirschl DR. Comparison of SF-36 and Short Musculoskeletal Functional Assessment in recovery from fixation of unstable ankle fractures. Orthopedics. 2007 Feb;30(2):145-51. doi: 10.3928/01477447-20070201-01.
Results Reference
background
PubMed Identifier
6437370
Citation
Olerud C, Molander H. A scoring scale for symptom evaluation after ankle fracture. Arch Orthop Trauma Surg (1978). 1984;103(3):190-4. doi: 10.1007/BF00435553.
Results Reference
background
PubMed Identifier
16891946
Citation
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.
Results Reference
background
PubMed Identifier
16500006
Citation
Shimamura Y, Kaneko K, Kume K, Maeda M, Iwase H. The initial safe range of motion of the ankle joint after three methods of internal fixation of simulated fractures of the medial malleolus. Clin Biomech (Bristol, Avon). 2006 Jul;21(6):617-22. doi: 10.1016/j.clinbiomech.2005.12.018. Epub 2006 Feb 24.
Results Reference
background
PubMed Identifier
16462563
Citation
Simanski CJ, Maegele MG, Lefering R, Lehnen DM, Kawel N, Riess P, Yucel N, Tiling T, Bouillon B. Functional treatment and early weightbearing after an ankle fracture: a prospective study. J Orthop Trauma. 2006 Feb;20(2):108-14. doi: 10.1097/01.bot.0000197701.96954.8c.
Results Reference
background
PubMed Identifier
3083644
Citation
Sondenaa K, Hoigaard U, Smith D, Alho A. Immobilization of operated ankle fractures. Acta Orthop Scand. 1986 Feb;57(1):59-61. doi: 10.3109/17453678608993217.
Results Reference
background
PubMed Identifier
17723786
Citation
Strauss EJ, Egol KA. The management of ankle fractures in the elderly. Injury. 2007 Sep;38 Suppl 3:S2-9. doi: 10.1016/j.injury.2007.08.005.
Results Reference
background
PubMed Identifier
8636173
Citation
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.
Results Reference
background
PubMed Identifier
17257532
Citation
Vioreanu M, Dudeney S, Hurson B, Kelly E, O'Rourke K, Quinlan W. Early mobilization in a removable cast compared with immobilization in a cast after operative treatment of ankle fractures: a prospective randomized study. Foot Ankle Int. 2007 Jan;28(1):13-9. doi: 10.3113/FAI.2007.0003.
Results Reference
background
Citation
Siddique Amir, Prasad C.V.R, O'Connor D. Early Active Mobilization Versus Cast Immobilization in Operatively Treated Ankle Fractures. European Journal of Trauma 2005 No4 (31): 398-400
Results Reference
background
Citation
Kreder, Hans What is the Role of
Results Reference
background

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Early Weightbearing and Mobilization Versus Non-Weightbearing and Mobilization in Unstable Ankle Fractures

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