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| Name | Class |
|---|---|
| Orthopaedic Trauma Association | OTHER |
| Canadian Orthopaedic Foundation | OTHER |
| Künzli SwissSchuh | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early weight-bearing and range of motion exercises | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Richard Jenkinson, MD, FRCS(C) | Contact | 416-480-6100 | 7052 | richard.jenkinson@sunnybrook.ca |
| Hans Kreder, MD,MPH,FRCSC | Contact | 416-480-6100 | 6816 | hans.kreder@sunnybrook.ca |
| Name | Affiliation | Role |
|---|---|---|
| Richard Jenkinson, MD, FRCSC | Sunnybrook Health Sciences Centre | Principal Investigator |
| Hans Kreder, MD,MPH,FRCSC | Sunnybrook Health Sciences Centre | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Centre | Recruiting | Toronto | Ontario | M4N 3M5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8451961 | 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. | |
| 2502344 | Background | Ahl T, Dalen N, Selvik G. Ankle fractures. A clinical and roentgenographic stereophotogrammetric study. Clin Orthop Relat Res. 1989 Aug;(245):246-55. |
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| ID | Term |
|---|---|
| D016512 | Ankle Injuries |
| D064386 | Ankle Fractures |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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| ID | Term |
|---|---|
| D016059 | Range of Motion, Articular |
| ID | Term |
|---|---|
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D009142 | Musculoskeletal Physiological Phenomena |
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|
| non-weight bearing, no range of motion | Behavioral |
|
|
| 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 |
| 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 |
| 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 |
| 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 |
| St. Michael's Hopspital | Recruiting | Toronto | Ontario | M5B 1W8 | Canada |
|
| 2044269 | 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. |
| 17715727 | 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. |
| 10755435 | 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. |
| 17195934 | 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. |
| 12571295 | 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. |
| 18646131 | Background | 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. |
| 18096062 | Background | 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. |
| 17323637 | Background | 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. |
| 6437370 | Background | 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. |
| 16891946 | 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. |
| 16500006 | Background | 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. |
| 16462563 | Background | 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. |
| 3083644 | Background | 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. |
| 17723786 | Background | 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. |
| 8636173 | 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. |
| 17257532 | Background | 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. |
| Background | 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 |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |