Outcome of Rehabilitation Following Internally Fixed Ankle Fractures
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|ClinicalTrials.gov Identifier: NCT02160197|
Recruitment Status : Unknown
Verified June 2014 by Wei Yee Leong, Countess of Chester NHS Foundation Trust.
Recruitment status was: Not yet recruiting
First Posted : June 10, 2014
Last Update Posted : June 10, 2014
The purpose of this study is to examine the effect of variations in practice, ranging from early functional rehabilitation to complete immobilsation in post operative patients with ankle fixation following fractures. The primary goal of any post-operative regimen is to attain full weight-bearing and as close to pre-injury levels of activity as soon as possible.
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.
|Condition or disease||Intervention/treatment||Phase|
|Ankle Fractures Fracture||Device: Aircast XP Walker boot Device: Plaster Immobilisation||Not Applicable|
Although the indications for fixation of an ankle fracture are relatively clear, controversy exists with regards the post-operative management of these fractures.
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.
Gul AG, Batra S, Meehmood S, Gillham N. Immediate unprotected weight-bearing of operatively treated ankle fractures. Acta Orthop Belgica 2007;73:360-365.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||105 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Randomised Controlled Trial of Outcome of Different Post Operative Rehabilitation Regime Following Internally Fixed Ankle Fractures|
|Study Start Date :||August 2014|
|Estimated Primary Completion Date :||August 2016|
|Estimated Study Completion Date :||August 2016|
No Intervention: No Immobilisation
No immobilisation post op, allowing patients to weight bear as tolerated.
Active Comparator: Functional Bracing
Immobilise patients in Functional brace, allowing patients to weight bear as tolerated.
Device: Aircast XP Walker boot
Ankle boot allowing weight bearing as tolerated
Other Name: Functional Bracing
Active Comparator: Plaster Immobilisation
Immobilise patients in plaster, allowing patients to weight bear as tolerated.
Device: Plaster Immobilisation
Plaster immobilisation with no weight bearing allowed.
- MOxFQ score (Manchester and Oxford Foot Questionaire [ Time Frame: 1 year ]16-item Patient Reported Outcome (PRO) measures developed and validated for use in clinical trials involving foot surgery. These self-administered PROs assesses how foot problems impair health-related quality of life can be completed before and after surgery.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02160197
|Contact: Wei Y Leong, MBChB, MRCS||01244 email@example.com|
|Contact: Kate Thomason, MB ChB, FRCS||01244 firstname.lastname@example.org|
|Countess of Chester NHS Foundation Trust|
|Chester, Cheshire, United Kingdom, CH2 1UL|
|Contact: Kate Thomason 01244 365000|
|Sub-Investigator: William Harrison, BA, MA, FRCS|
|Sub-Investigator: Edward Wood, MB ChB, FRCS|
|Sub-Investigator: Kate Thomason, MB ChB, FRCS|
|Principal Investigator:||Wei Y Leong, MBChB,MRCS||Countess of Chester NHS Foundation Trust|