Early Weightbearing and Mobilization Versus Non-Weightbearing and Mobilization in Unstable Ankle Fractures
NCT ID: NCT01196338
Last Updated: 2011-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
110 participants
INTERVENTIONAL
2010-09-30
2012-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Early Protected Full Weight-bearing vs. Partial Weight-bearing After Surgical Fixation of Unstable Ankle Fractures, Monitored With Bio-feedback Insoles.
NCT06023979
the Effect of Weight Bearing Status on Healing and Pain Outcomes After Surgery for Osteochondral Defects of the Ankle
NCT01405664
Outcome of Rehabilitation Following Internally Fixed Ankle Fractures
NCT02160197
Post Operative Ankle Splint Study - Prospective Multi Center Randomized Controlled Trial
NCT04796168
Syndesmosis Ankle Study
NCT03970603
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Non-weightbearing no ROM
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.
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.
Early weight-bearing and ROM
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Treatment within two weeks of injury
* Closed or low grade open ankle fracture (grade 1 and/or 2)
* Skeletally mature
Exclusion Criteria
* 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
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Orthopaedic Trauma Association
OTHER
Canadian Orthopaedic Foundation
OTHER
Künzli SwissSchuh
UNKNOWN
University of Toronto
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sunnybrook Health Sciences Centre
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Richard Jenkinson, MD, FRCSC
Role: PRINCIPAL_INVESTIGATOR
Sunnybrook Health Sciences Centre
Hans Kreder, MD,MPH,FRCSC
Role: STUDY_CHAIR
Sunnybrook Health Sciences Centre
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
St. Michael's Hopspital
Toronto, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Ahl T, Dalen N, Selvik G. Ankle fractures. A clinical and roentgenographic stereophotogrammetric study. Clin Orthop Relat Res. 1989 Aug;(245):246-55.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
Kreder, Hans What is the Role of
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Ankle
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.