Outcome of Rehabilitation Following Internally Fixed Ankle Fractures

Not Applicable

• Conditions: Ankle Fractures; Fracture
• Interventions: Device: Plaster Immobilisation; Device: Aircast XP Walker boot

• Registration Number: NCT02160197
• Lead Sponsor: Countess of Chester NHS Foundation Trust

Brief Summary

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.

Detailed Description

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.

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.

Study Timeline

• Status Verified: 2014-06
• Study First Submitted: 2014-06-09
• Study First Submitted QC: 2014-06-09
• Last Update Submitted: 2014-06-09
• Study First Posted: 2014-06-10
• Last Update Posted: 2014-06-10
• Study Start: 2014-08
• Primary Completion: 2016-08
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• Unstable and/or displaced Weber B ankle fractures
• 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

• Weber C ankle fractures
• Patient from outside of region where follow-up will be in a different unit.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plaster Immobilisation	Plaster Immobilisation	Immobilise patients in plaster, allowing patients to weight bear as tolerated.
Functional Bracing	Aircast XP Walker boot	Immobilise patients in Functional brace, allowing patients to weight bear as tolerated.

Primary Outcome Measures

Name	Time	Method
MOxFQ score (Manchester and Oxford Foot Questionaire	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.

Trial Locations

Locations (1)

Countess of Chester NHS Foundation Trust; 🇬🇧 Chester, Cheshire, United Kingdom