Outcome of Rehabilitation Following Internally Fixed Ankle Fractures

• ClinicalTrials.gov Identifier: NCT02160197
• Recruitment Status: Unknown
• Last Update Posted: June 10, 2014
• Sponsor: Countess of Chester NHS Foundation Trust
• Information provided by (Responsible Party): Wei Yee Leong, Countess of Chester NHS Foundation Trust

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Ankle Fractures; Fracture	Device: Aircast XP Walker boot; Device: Plaster Immobilisation	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 105 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Wei Y Leong, MBChB, MRCS; 01244 365000; wleong@nhs.net

Contact: Kate Thomason, MB ChB, FRCS; 01244 365000; kthomason@nhs.net

Locations

United Kingdom

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

Sponsors and Collaborators

Countess of Chester NHS Foundation Trust

Investigators

• Principal Investigator: Wei Y Leong, MBChB,MRCS; Countess of Chester NHS Foundation Trust

More Information

Publications:

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.

• Responsible Party: Wei Yee Leong, Clinical Research Registrar Trauma and Orthopaedic Surgery, Countess of Chester NHS Foundation Trust
• ClinicalTrials.gov Identifier: NCT02160197
• Other Study ID Numbers: 142804
• First Posted: June 10, 2014
• Last Update Posted: June 10, 2014
• Last Verified: June 2014

Keywords provided by Wei Yee Leong, Countess of Chester NHS Foundation Trust:

Ankle Fractures; Fracture Fixation; Early Ambulation; Fracture Healing; Return to Work

Additional relevant MeSH terms:

Fractures, Bone; Ankle Fractures; Wounds and Injuries; Ankle Injuries; Leg Injuries