NCT02160197

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 10, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

June 10, 2014

Status Verified

June 1, 2014

Enrollment Period

2 years

First QC Date

June 9, 2014

Last Update Submit

June 9, 2014

Conditions

Ankle FracturesFracture

Keywords

Ankle FracturesFracture FixationEarly AmbulationFracture HealingReturn to Work

Outcome Measures

Primary Outcomes (1)

  • MOxFQ score (Manchester and Oxford Foot Questionaire

    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.

    1 year

Study Arms (3)

No Immobilisation

NO INTERVENTION

No immobilisation post op, allowing patients to weight bear as tolerated.

Functional Bracing

ACTIVE COMPARATOR

Immobilise patients in Functional brace, allowing patients to weight bear as tolerated.

Device: Aircast XP Walker boot

Plaster Immobilisation

ACTIVE COMPARATOR

Immobilise patients in plaster, allowing patients to weight bear as tolerated.

Device: Plaster Immobilisation

Interventions

Aircast XP Walker bootDEVICE

Ankle boot allowing weight bearing as tolerated

Also known as: Functional Bracing
Functional Bracing
Plaster ImmobilisationDEVICE

Plaster immobilisation with no weight bearing allowed.

Plaster Immobilisation

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Countess of Chester NHS Foundation Trust

Chester, Cheshire, CH2 1UL, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 17715727BACKGROUND

  • 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.

    PMID: 10755435BACKGROUND

  • 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.

    PMID: 8636173BACKGROUND

MeSH Terms

Conditions

Ankle FracturesFractures, Bone

Condition Hierarchy (Ancestors)

Wounds and InjuriesAnkle InjuriesLeg Injuries

Study Officials

  • Wei Y Leong, MBChB,MRCS

    Countess of Chester NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Y Leong, MBChB, MRCS

CONTACT

01244 365000wleong@nhs.net

Kate Thomason, MB ChB, FRCS

CONTACT

01244 365000kthomason@nhs.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research Registrar Trauma and Orthopaedic Surgery

Study Record Dates

First Submitted

June 9, 2014

First Posted

June 10, 2014

Study Start

August 1, 2014

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

June 10, 2014

Record last verified: 2014-06

Locations

GB(1)