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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
Sponsor:
Information provided by (Responsible Party):
Wei Yee Leong, 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.


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.

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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

Resource links provided by the National Library of Medicine


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.




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.



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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.

Information from the National Library of Medicine

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


Contacts
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Contact: Wei Y Leong, MBChB, MRCS 01244 365000 wleong@nhs.net
Contact: Kate Thomason, MB ChB, FRCS 01244 365000 kthomason@nhs.net

Locations
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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
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Principal Investigator: Wei Y Leong, MBChB,MRCS Countess of Chester NHS Foundation Trust
Publications:
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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    Key Record Dates
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:
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Fractures, Bone
Ankle Fractures
Wounds and Injuries