Outcome of Rehabilitation Following Internally Fixed Ankle Fractures
NCT ID: NCT02160197
Last Updated: 2014-06-10
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
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UNKNOWN
NA
105 participants
INTERVENTIONAL
2014-08-31
2016-08-31
Brief Summary
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We seek to establish the effect on (1) functional outcome, (2) complication rates and (3) time to return to work of three different approaches to rehabilitation after ankle fracture fixation in order to produce a standardised, evidence-based guideline for our unit. We also aim to perform a cost analysis for each approach.
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Detailed Description
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This is a prospective randomised controlled trial. All patients admitted to the Countess of Chester NHS Foundation Trust Orthopaedic Unit for ankle fracture fixation who met the set study inclusion criteria will be given a patient information pack regarding the trial and asked to complete a consent form to enter the trial AFTER their operation has been performed. All patients will initially have their ankle immobilised in a below knee backslab applied in theatre and reviewed at 2 weeks in the plaster room for removal of plaster and sutures. At this setting the patient will be randomised to 1 of 3 rehabilitation arms using a sealed envelope technique. All patients data will be anonymised following generation of a randomisation number.
3 Orthopaedic Consultants (JH,KT,EW) will thereafter supervise follow-up of the study population until discharge at 1 year. Outcome measures recorded include patient -reported functional scores (MOxFQ); clinical assessment of range of motion, complication rates (loss of reduction); pain scores, satisfaction rates and return to work. Clinic review organised at 2 weeks for randomisation, 6 weeks for first post-op xrays and removal of plaster/ brace, 8 weeks for clinical review specifically range of movement achievable at ankle, 3 months with repeat Xray and clinical assessment, and final clinical review in clinic at 6 months in the fracture clinic. Telephone/ postal questionnaire to gather MoXFQ scores at 1 year.
There are no ethical or legal issues related to the studies.
One potential concern will be loss of reduction and fixation of ankle fractures following weight bearing without immobilisation. However, a study published by Gul et al in 2007 relating to immediate weight-bearing of operatively treated ankle fractures without immobilisation in cast showed no evidence of loss of reduction or hardware failure compared to historical controls.
Patients will be reviewed closely in the early period for loss of reduction as a safety outcome measure and the result will be monitored closely with earlier termination of trial should there be a concern. There will be monthly data review and monitoring during a research meeting.
Reference
Gul AG, Batra S, Meehmood S, Gillham N. Immediate unprotected weight-bearing of operatively treated ankle fractures. Acta Orthop Belgica 2007;73:360-365.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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No Immobilisation
No immobilisation post op, allowing patients to weight bear as tolerated.
No interventions assigned to this group
Functional Bracing
Immobilise patients in Functional brace, allowing patients to weight bear as tolerated.
Aircast XP Walker boot
Ankle boot allowing weight bearing as tolerated
Plaster Immobilisation
Immobilise patients in plaster, allowing patients to weight bear as tolerated.
Plaster Immobilisation
Plaster immobilisation with no weight bearing allowed.
Interventions
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Aircast XP Walker boot
Ankle boot allowing weight bearing as tolerated
Plaster Immobilisation
Plaster immobilisation with no weight bearing allowed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to give informed consent and follow instructions
* Previously independently mobile without previous ankle surgery
* Closed isolated ankle injury
* Not known to be neuropathic or osteoporotic
* Treated with standard Small Frag AO technique ie. Lag screws plus 1/3 tubular plate for fibula fixation and 2 screws/TBW on medial side with wounds closed using 2.0 vicyl and nonabsorbable monofilament to skin. (Standard AO ankle fixation technique)
Exclusion Criteria
* Patient from outside of region where follow-up will be in a different unit.
18 Years
50 Years
ALL
No
Sponsors
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Countess of Chester NHS Foundation Trust
OTHER
Responsible Party
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Wei Yee Leong
Clinical Research Registrar Trauma and Orthopaedic Surgery
Principal Investigators
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Wei Y Leong, MBChB,MRCS
Role: PRINCIPAL_INVESTIGATOR
Countess of Chester NHS Foundation Trust
Locations
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Countess of Chester NHS Foundation Trust
Chester, Cheshire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Kate Thomason
Role: primary
References
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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.
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.
Other Identifiers
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142804
Identifier Type: -
Identifier Source: org_study_id
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