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

Ankle Injuries Clinical Trial

Official title:

Early Weightbearing and Mobilization Versus Non-Weightbearing and Immobilization After ORIF of Unstable Ankle Fractures: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01196338
• Other study ID #: Ankle
• Status: Recruiting
• Phase: N/A
• First received: September 1, 2010
• Last updated: June 9, 2011
• Start date: September 2010
• Est. completion date: June 2012

Study information

• Verified date: September 2010
• Source: University of Toronto
• Contact: Richard Jenkinson, MD, FRCS(C)
• Phone: 416-480-6100
• Email: richard.jenkinson[@]sunnybrook.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: June 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Fractures
• Ankle Injuries

Intervention

Behavioral:
• Early weight-bearing and range of motion exercises
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.
• non-weight bearing, no range of motion
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.

Locations

Country	Name	City	State
Canada	St. Michael's Hopspital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
University of Toronto	Canadian Orthopaedic Foundation, Künzli SwissSchuh, Orthopaedic Trauma Association

Country where clinical trial is conducted

Canada, 

References & Publications (20)

Ahl T, Dalén 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. — View Citation

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

Honigmann P, Goldhahn S, Rosenkranz J, Audigé 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. Epub 2006 Dec 30. — View Citation

Kreder, Hans What is the Role of

Lehtonen H, Järvinen TL, Honkonen S, Nyman M, Vihtonen K, Järvinen 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-A(2):205-11. — View 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. Review. Update in: Cochrane Database Syst Rev. 2012;11:CD005595. — View 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. — View 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. — View Citation

Olerud C, Molander H. A scoring scale for symptom evaluation after ankle fracture. Arch Orthop Trauma Surg. 1984;103(3):190-4. — View 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. Review. — View 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. Epub 2006 Feb 24. — View 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

Simanski CJ, Maegele MG, Lefering R, Lehnen DM, Kawel N, Riess P, Yücel 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. — View Citation

Søndenaa K, Høigaard U, Smith D, Alho A. Immobilization of operated ankle fractures. Acta Orthop Scand. 1986 Feb;57(1):59-61. — View Citation

Strauss EJ, Egol KA. The management of ankle fractures in the elderly. Injury. 2007 Sep;38 Suppl 3:S2-9. Review. — View 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. — View 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. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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?	2 weeks	No
Secondary	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?	6 weeks	No
Secondary	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?	9 weeks	No
Secondary	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?	6 months	No
Secondary	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?	12 months	No