Ankle InjuriesNCT01196338
Early Weightbearing and Mobilization Versus Non-Weightbearing and Mobilization in Unstable Ankle Fractures
A study testing Early weight-bearing and range of motion exercises and non-weight bearing, no range of motion in people with Ankle Injuries, run by University of Toronto at 2 sites in Canada.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ankle Injuries
- What is being tested?
- Early weight-bearing and range of motion exercises and non-weight bearing, no range of motion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2010to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Tibial plafond fractures including articular impaction requiring elevation
- Syndesmosis injury requiring fixation
- Posterior Malleolus fracture - more than 25% of articular surface
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Richard Jenkinson, MD, FRCSC, 416-480-6100 ext. 7052, richard.jenkinson@sunnybrook.ca
Hans Kreder, MD,MPH,FRCSC, 416-480-6100 ext. 6816, hans.kreder@sunnybrook.ca
- Recruiting
St. Michael's Hopspital
Toronto, Ontario, M5B 1W8
Niloofar Dehghan, BSc, MD, 416-997-8735, niloofar.dehghan@utoronto.ca
Michael McKee, MD, FRCSC, 416-864-5880, mckeem@smh.ca
About this study
Official title: Early Weightbearing and Mobilization Versus Non-Weightbearing and Immobilization After ORIF of Unstable Ankle Fractures: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Ankle Injuries
- Being tested
- Early weight-bearing and range of motion exercises, non-weight bearing, no range of motion
- Keywords
- Ankle fracture, Return to work, Return to function, Rehabilitation, Weight-bearing
- Medical subject headings
- Ankle Injuries, Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early weight-bearing and range of motion exercisesBehavioural
- 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 motionBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Early weight-bearing and range of motion exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 3 months
Secondary outcomes (5)
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?
Measured: 2 weeks
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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionJan 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Ankle InjuriesStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopaedic Trauma Association, Canadian Orthopaedic Foundation, Künzli SwissSchuh
- Investigators
- Richard Jenkinson, MD, FRCSC, Principal investigator, Sunnybrook Health Sciences CentreHans Kreder, MD,MPH,FRCSC, Study chair, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196338
- Sponsor's protocol ID
- Ankle
- Status last verified
- Sep 2010
- First submitted
- 1 Sep 2010
- Last updated
- 13 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 8451961Ahl T, Dalen N, Selvik G. Ankle fractures. A clinical and roentgenographic stereophotogrammetric study. Clin Orthop Relat Res. 1989 Aug;(245):246-55.
PubMed 2502344Cimino 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.
PubMed 2044269Gul 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.
PubMed 17715727Egol 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.
PubMed 10755435Honigmann 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.
PubMed 17195934Lehtonen 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.
PubMed 12571295Lin 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.
PubMed 18646131Nilsson 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.
PubMed 18096062Obremskey 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.
PubMed 17323637Olerud 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.
PubMed 6437370Petrisor 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.
PubMed 16891946Shimamura 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.
PubMed 16500006Simanski 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.
PubMed 16462563Sondenaa 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.
PubMed 3083644
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Weightbearing and Mobilization Versus Non-Weightbearing and Immobilization After ORIF of Unstable Ankle Fractures: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01196338
- Acronym / sponsor ID
- Ankle
- Conditions
- Ankle Injuries
- Keywords
- Ankle fracture, Return to work, Return to function, Rehabilitation, Weight-bearing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Orthopaedic Trauma Association, Canadian Orthopaedic Foundation, Künzli SwissSchuh
- Study start
- Sep 2010
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 8 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-weightbearing no ROM | Active comparator | Behavioral: non-weight bearing, no range of motionPatients 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. |
| Early weight-bearing and ROM | Experimental | Behavioral: Early weight-bearing and range of motion exercisesPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Early weight-bearing and ROM |
| 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. | Behavioural | Non-weightbearing no ROM |
Primary outcome
Return to work
Time frame: 3 months
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?
5 secondary outcomes
Functional outcome and event rate
Time frame: 2 weeks
Functional outcome and event rate
Time frame: 6 weeks
Return to work and functional outcome
Time frame: 9 weeks
Return to work and functional outcome
Time frame: 6 months
Return to work and functional outcome
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2011.
- Background: PubMed 8451961Ahl 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.
- Background: PubMed 2502344Ahl T, Dalen N, Selvik G. Ankle fractures. A clinical and roentgenographic stereophotogrammetric study. Clin Orthop Relat Res. 1989 Aug;(245):246-55.
- Background: PubMed 2044269Cimino 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.
- Background: PubMed 17715727Gul 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.
- Background: PubMed 10755435Egol 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.
- Background: PubMed 17195934Honigmann 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.
- Background: PubMed 12571295Lehtonen 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.
- Background: PubMed 18646131Lin 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.
- Background: PubMed 18096062Nilsson 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.
- Background: PubMed 17323637Obremskey 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.
- Background: PubMed 6437370Olerud 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.
- Background: PubMed 16891946Petrisor 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Jenkinson, MD, FRCSC principal investigator
Sunnybrook Health Sciences Centre
Hans Kreder, MD,MPH,FRCSC study chair
Sunnybrook Health Sciences Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early weight-bearing and range of motion exercises and non-weight bearing, no range of motion in people with Ankle Injuries, run by University of Toronto at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard Jenkinson, MD, FRCS(C) (416-480-6100 ext. 7052, richard.jenkinson@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return to work (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01196338, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2011.