Ankle FracturesNCT03032653
Immediate Weight-Bearing Ankle Study
A study testing Late Rehabilitation and Early Rehabilitation in people with Ankle Fractures and Surgery, run by Fraser Orthopaedic Research Society at 1 site in Canada.
Trial summary
This single-centre historical control group comparative study will compare outcomes of surgically-treated rotational ankle fractures and the current routine practice of early protected weightbearing and range of motion with immediate unprotected weightbearing as tolerated and range of motion after ankle open reduction… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Fractures, Surgery
- What is being tested?
- Late Rehabilitation and Early Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 9 Feb 2017to 18 Jan 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- lateral malleolus fracture with talar shaft
- vertical shear medial malleolus fracture without superior articular involvement
- bimalleolar fracture
- any ankle fracture with posterior malleolus fragment involving 25% or less of the articular surface on the lateral ankle radiograph
- 43.B1 (pure split of distal tibia - but only if does not involve any of tibial plafond, i.e., only the vertical split of medial malleolus)
- 44.A1 (Weber A)
Show all 15Show fewer
- 44.A2 (Bimalleolar)
- 44.A3 (posterior malleolus involvement - but only if < 25% articular involvement on lateral x-ray)
- 44-B1 (Isolated)
- 44.B2 (with medial lesion)
- 44.B3 (with medial lesion \& Volkmann's #)
- closed, Gustilo-Anderson Grade I or Grade II open fractures are included
- willing and able to sign the consent
- willing and able to follow the protocol and attend follow-up visits
- able to read and understand English or have an interpreter available
Who cannot join
- skeletal immaturity demonstrated radiographically by open physes
- previous ipsilateral ankle surgery
- bilateral ankle fractures
- non ambulatory prior to injury
- inability to comply with postoperative protocol (i.e., cognitive impairment)
- medical comorbidity precluding surgery
Show all 18Show fewer
- poorly controlled diabetes (i.e. dense neuropathy / hx of ulcers / sensory deficit)
- polytrauma patients (other injuries involving the ipsi/contralateral lower limbs, including the hip, that would interfere with mobilization/rehabilitation)
- surgical date > 14 days (time of injury to OR)
- Gustilo-Anderson grade III open fractures
- tibial plafond fractures
- active infection at the surgical site diagnosed clinically by the attending surgeon
- any ankle fracture with posterior malleolus fragment involving more than 25% of the articular surface on the lateral ankle radiograph
- any medial malleolus fracture involving the superior articular surface
- any ankle fracture requiring syndesmosis fixation
- any ankle fracture-dislocation
- incarceration
- likely problems, in the judgment of the investigator, with maintaining follow-up
Trial locations and contacts
1 site in 1 country.
Canada1 site
Royal Columbian Hospital / Fraser Health Authority
New Westminster, British Columbia, V3L 3M2
About this study
Official title: Immediate Unprotected Weight-Bearing and Range of Motion After Open Reduction and Internal Fixation of Unstable Ankle Fractures. A Historical Control Group Comparative Study
This single-centre historical control group comparative study will compare outcomes of surgically-treated rotational ankle fractures and the current routine practice of early protected weightbearing and range of motion with immediate unprotected weightbearing as tolerated and range of motion after ankle open reduction and internal fixation.
Read the detailed description
Ankle fractures are among the most common injuries, making up 9% of all fractures. Rotational ankle fractures are among the most common of all fractures, with an incidence averaging 4.2 per 1,000 individuals annually. These fractures range from minimal injuries amenable to non-surgical management to complex injuries with potential of long-term sequelae. Known risk factors for ankle fractures are age, body mass index and previous ankle fracture, with the highest incidence in elderly women.
Most ankle fractures are low-energy injuries which occur when the body rotates about a planted foot, whether it be during sports, normal gait, or otherwise. Stable ankle fractures are generally treated non-surgically, while unstable fractures are usually treated with surgical reduction and fixation, with indications previously well-described and published.
However, the post-operative management of such injuries is still controversial, with large variability between care providers. Protocols range from complete immobilization of the affected ankle and non-weightbearing to early range-of-motion (ROM) and weightbearing (WB). Studies have compared immobilization and non-WB to early ROM and WB but results have been mixed, with the most recent study demonstrating safety and advantages to protected WB and ROM at two weeks post-operatively versus non-WB and immobilization for six weeks.
The Investigators intend to expand on the studies above and propose a single-centre historical control group comparative study to compare outcomes of surgically-treated rotational ankle fractures and the current routine practice of early protected weightbearing and range of motion with immediate unprotected weightbearing as tolerated and range of motion after ankle open reduction and internal fixation.
- Conditions
- Ankle Fractures, Surgery
- Being tested
- Late Rehabilitation, Early Rehabilitation
- Keywords
- ankle, fracture, rehabilitation, weightbearing, early, late
- Medical subject headings
- Ankle Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Late RehabilitationOther
Post-0p: Non weight-bearing and no range of motion for 2 weeks post treatment. 2 weeks: Splint removed, removable pre-fabricated walking boot applied. WB as tolerated with boot, range of motion out of boot.
6 weeks: Boot discontinued and full unrestricted and unprotected WB and ROM permitted 6 weeks:
Early RehabilitationOther
Weightbearing and range of motion as tolerated within the limitations of participant's own comfort. Use of ambulatory aides of any kind is permitted as needed without restriction. No brace or splint of any kind is permitted
| Study group | Role | What they receive |
|---|---|---|
| Late WB | Active comparator | Intervention: Patients receive a plaster splint in the operating room. They are not permitted to WB or ROM on the affected limb at this stage. At the first follow-up appointment (two weeks post-op), the splint is removed and a removable pre-fabricated walking boot applied. At this stage the patient is permitted to WB as tolerated while wearing the boot, and to perform ROM exercises with the boot removed. At six weeks post-op, the boot is discontinued and full unrestricted and unprotected weightbearing and ROM is permitted. Receives: Other: Late Rehabilitation |
| Immediate unprotected WB and ROM | Experimental | Patient do NOT receive a brace or splint of any kind. They are permitted to weightbear and range of motion as tolerated within the limitations of their own comfort. Use of ambulatory aids of any kind is permitted as needed without restrictions. Receives: Other: Early Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Olerud and Molander Score
An assessment of symptoms after ankle fracture.
Measured: 6 weeks post treatment
Secondary outcomes (8)
EQ-5D
Health Related quality of life outcome measure using five dimensions: Mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Measured: 2, 6 and 12 weeks post treatment
WPAI:SHP Work Productivity and Activity Impairment Questionnaire: Specific Health Problem
A questionnaire pertaining to the effect of the participant's ankle fracture on their ability to work and perform regular activities.
Measured: 2, 6 and 12 weeks post treatment
Range of Motion
Amount of ankle dorsiflexion and plantarflexion (measured in degrees) as determined by goniometer assessment, as well as total arc of ankle ROM (dorsiflexion+ plantarflexion). This will be measured on both ankles for comparison.
Measured: 2, 6 and 12 weeks post treatment
Wound Healing
Complications regarding the surgical wound, including but not limited to signs of infection or dehiscence.
Measured: 2, 6 and 12 weeks post treatment
Fracture Healing
Radiographic assessment to determine healing, loss of reduction, loss of hardware fixation, or ankle alignment.
Measured: 2, 6 and 12 weeks post treatment
Need for Re-operation
Any issue, whether it be a wound complication or fracture complication, requiring re-operation.
Measured: 2, 6 and 12 weeks post treatment
Time to Return to Work
The chronological time between the date of surgery to the first day the participant returned to occupational duties, if currently employed and returns to work within the 12 weeks postoperative follow-up period. For the purposes of this study, students enrolled in educational activities will have their schooling treated as their occupational duty.
Measured: 2, 6 and 12 weeks post treatment
Radiographic assessment
Assessment of alignment, hardware fixation, fracture reduction and loss of reduction (defined as any shft of 2mm or more in fracture position)
Measured: 2, 6 and 12 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start9 Feb 2017
- Primary completion18 Jan 2021
- Study completion18 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Ankle FracturesStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fraser Orthopaedic Research Society
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Darius G Viskontas, MD, FRCSC, Principal investigator, Royal Columbian Hospital / Fraser Health AuthorityVu (Brian) Le, MD, FRSCS, Principal investigator, Royal Columbian Hospital / Fraser Health AuthorityKelly L Apostle, MD, FRCSC, Principal investigator, Royal Columbian Hospital / Fraser Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032653
- Sponsor's protocol ID
- FHREB #: 2016-101
- Status last verified
- Apr 2021
- First submitted
- 24 Jan 2017
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Court-Brown CM, Caesar B. Epidemiology of adult fractures: A review. Injury. 2006 Aug;37(8):691-7. doi: 10.1016/j.injury.2006.04.130. Epub 2006 Jun 30.
PubMed 16814787Hoelsbrekken SE, Kaul-Jensen K, Morch T, Vika H, Clementsen T, Paulsrud O, Petursson G, Stiris M, Stromsoe K. Nonoperative treatment of the medial malleolus in bimalleolar and trimalleolar ankle fractures: a randomized controlled trial. J Orthop Trauma. 2013 Nov;27(11):633-7. doi: 10.1097/BOT.0b013e31828e1bb7.
PubMed 23454858Petrisor 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 16891946Michelson JD, Magid D, McHale K. Clinical utility of a stability-based ankle fracture classification system. J Orthop Trauma. 2007 May;21(5):307-15. doi: 10.1097/BOT.0b013e318059aea3.
PubMed 17485995Dehghan N, McKee MD, Jenkinson RJ, Schemitsch EH, Stas V, Nauth A, Hall JA, Stephen DJ, Kreder HJ. Early Weightbearing and Range of Motion Versus Non-Weightbearing and Immobilization After Open Reduction and Internal Fixation of Unstable Ankle Fractures: A Randomized Controlled Trial. J Orthop Trauma. 2016 Jul;30(7):345-52. doi: 10.1097/BOT.0000000000000572.
PubMed 27045369Gul 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 17715727O'Sullivan ME, Bronk JT, Chao EY, Kelly PJ. Experimental study of the effect of weight bearing on fracture healing in the canine tibia. Clin Orthop Relat Res. 1994 May;(302):273-83.
PubMed 8168314Lehtonen 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 12571295Honigmann 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 17195934van 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.
PubMed 8636173Ahl 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 8451961Finsen V, Saetermo R, Kibsgaard L, Farran K, Engebretsen L, Bolz KD, Benum P. Early postoperative weight-bearing and muscle activity in patients who have a fracture of the ankle. J Bone Joint Surg Am. 1989 Jan;71(1):23-7.
PubMed 2492286Cimino 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 2044269Hedstrom M, Ahl T, Dalen N. Early postoperative ankle exercise. A study of postoperative lateral malleolar fractures. Clin Orthop Relat Res. 1994 Mar;(300):193-6.
PubMed 8131334Egol 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 10755435
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Unprotected Weight-Bearing and Range of Motion After Open Reduction and Internal Fixation of Unstable Ankle Fractures. A Historical Control Group Comparative Study
- ClinicalTrials.gov ID
- NCT03032653
- Acronym / sponsor ID
- FHREB #: 2016-101
- Conditions
- Ankle Fractures, Surgery
- Keywords
- ankle, fracture, rehabilitation, weightbearing, early, late
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Fraser Orthopaedic Research SocietyResearch network
- Study start
- 9 Feb 2017 (actual)
- Primary completion
- 18 Jan 2021 (actual)
- Study completion
- 18 Jan 2021 (actual)
- First posted
- 26 Jan 2017 (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.
This single-centre historical control group comparative study will compare outcomes of surgically-treated rotational ankle fractures and the current routine practice of early protected weightbearing and range of motion with immediate unprotected weightbearing as tolerated and range of motion after ankle open reduction and internal fixation.
Detailed description
Ankle fractures are among the most common injuries, making up 9% of all fractures. Rotational ankle fractures are among the most common of all fractures, with an incidence averaging 4.2 per 1,000 individuals annually. These fractures range from minimal injuries amenable to non-surgical management to complex injuries with potential of long-term sequelae. Known risk factors for ankle fractures are age, body mass index and previous ankle fracture, with the highest incidence in elderly women.
Most ankle fractures are low-energy injuries which occur when the body rotates about a planted foot, whether it be during sports, normal gait, or otherwise. Stable ankle fractures are generally treated non-surgically, while unstable fractures are usually treated with surgical reduction and fixation, with indications previously well-described and published.
However, the post-operative management of such injuries is still controversial, with large variability between care providers. Protocols range from complete immobilization of the affected ankle and non-weightbearing to early range-of-motion (ROM) and weightbearing (WB). Studies have compared immobilization and non-WB to early ROM and WB but results have been mixed, with the most recent study demonstrating safety and advantages to protected WB and ROM at two weeks post-operatively versus non-WB and immobilization for six weeks.
The Investigators intend to expand on the studies above and propose a single-centre historical control group comparative study to compare outcomes of surgically-treated rotational ankle fractures and the current routine practice of early protected weightbearing and range of motion with immediate unprotected weightbearing as tolerated and range of motion after ankle open reduction and internal fixation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Late WB | Active comparator | Other: Late RehabilitationIntervention: Patients receive a plaster splint in the operating room. They are not permitted to WB or ROM on the affected limb at this stage. At the first follow-up appointment (two weeks post-op), the splint is removed and a removable pre-fabricated walking boot applied. At this stage the patient is permitted to WB as tolerated while wearing the boot, and to perform ROM exercises with the boot removed. At six weeks post-op, the boot is discontinued and full unrestricted and unprotected weightbearing and ROM is permitted. |
| Immediate unprotected WB and ROM | Experimental | Other: Early RehabilitationPatient do NOT receive a brace or splint of any kind. They are permitted to weightbear and range of motion as tolerated within the limitations of their own comfort. Use of ambulatory aids of any kind is permitted as needed without restrictions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- lateral malleolus fracture with talar shaft
- vertical shear medial malleolus fracture without superior articular involvement
- bimalleolar fracture
- any ankle fracture with posterior malleolus fragment involving 25% or less of the articular surface on the lateral ankle radiograph
- 43.B1 (pure split of distal tibia - but only if does not involve any of tibial plafond, i.e., only the vertical split of medial malleolus)
Key exclusion criteria (18 listed)
- skeletal immaturity demonstrated radiographically by open physes
- previous ipsilateral ankle surgery
- bilateral ankle fractures
- non ambulatory prior to injury
- inability to comply with postoperative protocol (i.e., cognitive impairment)
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 |
|---|---|---|
| Late RehabilitationPost-0p: Non weight-bearing and no range of motion for 2 weeks post treatment. 2 weeks: Splint removed, removable pre-fabricated walking boot applied. WB as tolerated with boot, range of motion out of boot. 6 weeks: Boot discontinued and full unrestricted and unprotected WB and ROM permitted 6 weeks: | Other | Late WB |
| Early RehabilitationWeightbearing and range of motion as tolerated within the limitations of participant's own comfort. Use of ambulatory aides of any kind is permitted as needed without restriction. No brace or splint of any kind is permitted | Other | Immediate unprotected WB and ROM |
Primary outcome
Olerud and Molander Score
Time frame: 6 weeks post treatment
An assessment of symptoms after ankle fracture.
8 secondary outcomes
EQ-5D
Time frame: 2, 6 and 12 weeks post treatment
WPAI:SHP Work Productivity and Activity Impairment Questionnaire: Specific Health Problem
Time frame: 2, 6 and 12 weeks post treatment
Range of Motion
Time frame: 2, 6 and 12 weeks post treatment
Wound Healing
Time frame: 2, 6 and 12 weeks post treatment
Fracture Healing
Time frame: 2, 6 and 12 weeks post treatment
Need for Re-operation
Time frame: 2, 6 and 12 weeks post treatment
Time to Return to Work
Time frame: 2, 6 and 12 weeks post treatment
Radiographic assessment
Time frame: 2, 6 and 12 weeks post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
- Background: PubMed 16814787Court-Brown CM, Caesar B. Epidemiology of adult fractures: A review. Injury. 2006 Aug;37(8):691-7. doi: 10.1016/j.injury.2006.04.130. Epub 2006 Jun 30.
- Background: PubMed 23454858Hoelsbrekken SE, Kaul-Jensen K, Morch T, Vika H, Clementsen T, Paulsrud O, Petursson G, Stiris M, Stromsoe K. Nonoperative treatment of the medial malleolus in bimalleolar and trimalleolar ankle fractures: a randomized controlled trial. J Orthop Trauma. 2013 Nov;27(11):633-7. doi: 10.1097/BOT.0b013e31828e1bb7.
- 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.
- Background: PubMed 17485995Michelson JD, Magid D, McHale K. Clinical utility of a stability-based ankle fracture classification system. J Orthop Trauma. 2007 May;21(5):307-15. doi: 10.1097/BOT.0b013e318059aea3.
- Background: PubMed 27045369Dehghan N, McKee MD, Jenkinson RJ, Schemitsch EH, Stas V, Nauth A, Hall JA, Stephen DJ, Kreder HJ. Early Weightbearing and Range of Motion Versus Non-Weightbearing and Immobilization After Open Reduction and Internal Fixation of Unstable Ankle Fractures: A Randomized Controlled Trial. J Orthop Trauma. 2016 Jul;30(7):345-52. doi: 10.1097/BOT.0000000000000572.
- 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 8168314O'Sullivan ME, Bronk JT, Chao EY, Kelly PJ. Experimental study of the effect of weight bearing on fracture healing in the canine tibia. Clin Orthop Relat Res. 1994 May;(302):273-83.
- 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 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 8636173van 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.
- 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 2492286Finsen V, Saetermo R, Kibsgaard L, Farran K, Engebretsen L, Bolz KD, Benum P. Early postoperative weight-bearing and muscle activity in patients who have a fracture of the ankle. J Bone Joint Surg Am. 1989 Jan;71(1):23-7.
- Individual participant dataSharing planned: No
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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.
Darius G Viskontas, MD, FRCSC principal investigator
Royal Columbian Hospital / Fraser Health Authority
Vu (Brian) Le, MD, FRSCS principal investigator
Royal Columbian Hospital / Fraser Health Authority
Kelly L Apostle, MD, FRCSC principal investigator
Royal Columbian Hospital / Fraser Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Late Rehabilitation and Early Rehabilitation in people with Ankle Fractures and Surgery, run by Fraser Orthopaedic Research Society at 1 site 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 15 inclusion and 18 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: finished, as of the sponsor's last update on 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Olerud and Molander Score (time frame: 6 weeks post treatment). 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 NCT03032653, which also lists 16 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 23 Apr 2021.