NCT01196338

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 8, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

June 13, 2011

Status Verified

September 1, 2010

Enrollment Period

1.3 years

First QC Date

September 1, 2010

Last Update Submit

June 9, 2011

Conditions

Ankle Injuries

Keywords

Ankle fractureReturn to workReturn to functionRehabilitationWeight-bearing

Outcome Measures

Primary Outcomes (1)

  • 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?

    3 months

Secondary Outcomes (5)

  • Functional outcome and event rate

    2 weeks

  • Functional outcome and event rate

    6 weeks

  • Return to work and functional outcome

    9 weeks

  • Return to work and functional outcome

    6 months

  • Return to work and functional outcome

    12 months

Study Arms (2)

Non-weightbearing no ROM

ACTIVE COMPARATOR

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.

Behavioral: non-weight bearing, no range of motion

Early weight-bearing and ROM

EXPERIMENTAL

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.

Behavioral: Early weight-bearing and range of motion exercises

Interventions

Early weight-bearing and range of motion exercisesBEHAVIORAL

* 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.

Early weight-bearing and ROM
non-weight bearing, no range of motionBEHAVIORAL

* 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.

Non-weightbearing no ROM

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

St. Michael's Hopspital

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

Related Publications (20)

  • 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: 8451961BACKGROUND

  • Ahl T, Dalen N, Selvik G. Ankle fractures. A clinical and roentgenographic stereophotogrammetric study. Clin Orthop Relat Res. 1989 Aug;(245):246-55.

    PMID: 2502344BACKGROUND

  • 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: 2044269BACKGROUND

  • 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: 17715727BACKGROUND

  • 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: 10755435BACKGROUND

  • 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: 17195934BACKGROUND

  • 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: 12571295BACKGROUND

  • 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.

    PMID: 18646131BACKGROUND

  • 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.

    PMID: 18096062BACKGROUND

  • 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.

    PMID: 17323637BACKGROUND

  • 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.

    PMID: 6437370BACKGROUND

  • 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: 16891946BACKGROUND

  • 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). 2006 Jul;21(6):617-22. doi: 10.1016/j.clinbiomech.2005.12.018. Epub 2006 Feb 24.

    PMID: 16500006BACKGROUND

  • 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.

    PMID: 16462563BACKGROUND

  • 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.

    PMID: 3083644BACKGROUND

  • 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.

    PMID: 17723786BACKGROUND

  • 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: 8636173BACKGROUND

  • 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.

    PMID: 17257532BACKGROUND

  • 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

    BACKGROUND

  • Kreder, Hans What is the Role of

    BACKGROUND

MeSH Terms

Conditions

Ankle InjuriesAnkle Fractures

Interventions

Range of Motion, Articular

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

Physical ExaminationDiagnostic Techniques and ProceduresDiagnosisMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Richard Jenkinson, MD, FRCSC

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

  • Hans Kreder, MD,MPH,FRCSC

    Sunnybrook Health Sciences Centre

    STUDY CHAIR

Central Study Contacts

Richard Jenkinson, MD, FRCS(C)

CONTACT

416-480-6100richard.jenkinson@sunnybrook.ca

Hans Kreder, MD,MPH,FRCSC

CONTACT

416-480-6100hans.kreder@sunnybrook.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 1, 2010

First Posted

September 8, 2010

Study Start

September 1, 2010

Primary Completion

January 1, 2012

Study Completion

June 1, 2012

Last Updated

June 13, 2011

Record last verified: 2010-09

Locations

CA(2)