Ankle FracturesNCT02160197
Outcome of Rehabilitation Following Internally Fixed Ankle Fractures
A study testing Aircast XP Walker boot and Plaster Immobilisation in people with Ankle Fractures and Fracture, run by Countess of Chester NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Ankle Fractures, Fracture
- What is being tested?
- Aircast XP Walker boot and Plaster Immobilisation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2014to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- Weber C ankle fractures
- Patient from outside of region where follow-up will be in a different unit.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Countess of Chester NHS Foundation Trust
Chester, Cheshire, CH2 1UL
Kate Thomason, 01244 365000
William Harrison, BA, MA, FRCS
About this study
Official title: A Randomised Controlled Trial of Outcome of Different Post Operative Rehabilitation Regime Following Internally Fixed Ankle Fractures
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.
Read the 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.
- Conditions
- Ankle Fractures, Fracture
- Being tested
- Aircast XP Walker boot, Plaster Immobilisation
- Keywords
- Ankle Fractures, Fracture Fixation, Early Ambulation, Fracture Healing, Return to Work
- Medical subject headings
- Ankle Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aircast XP Walker bootDevice
Also called Functional Bracing
Ankle boot allowing weight bearing as tolerated
Plaster ImmobilisationDevice
Plaster immobilisation with no weight bearing allowed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Aircast XP Walker boot |
| Plaster Immobilisation | Active comparator | Immobilise patients in plaster, allowing patients to weight bear as tolerated. Receives: Device: Plaster Immobilisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ankle FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Countess of Chester NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Yee Leong, Countess of Chester NHS Foundation Trust
- Investigators
- Wei Y Leong, MBChB,MRCS, Principal investigator, Countess of Chester NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160197
- Sponsor's protocol ID
- 142804
- Status last verified
- Jun 2014
- First submitted
- 9 Jun 2014
- Last updated
- 10 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 17715727Egol 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.
PubMed 10755435van 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.
PubMed 8636173
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Outcome of Different Post Operative Rehabilitation Regime Following Internally Fixed Ankle Fractures
- ClinicalTrials.gov ID
- NCT02160197
- Acronym / sponsor ID
- 142804
- Conditions
- Ankle Fractures, Fracture
- Keywords
- Ankle Fractures, Fracture Fixation, Early Ambulation, Fracture Healing, Return to Work
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Countess of Chester NHS Foundation TrustUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 10 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Immobilisation | No intervention | –No immobilisation post op, allowing patients to weight bear as tolerated. |
| Functional Bracing | Active comparator | Device: Aircast XP Walker bootImmobilise patients in Functional brace, allowing patients to weight bear as tolerated. |
| Plaster Immobilisation | Active comparator | Device: Plaster ImmobilisationImmobilise patients in plaster, allowing patients to weight bear as tolerated. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Weber C ankle fractures
- Patient from outside of region where follow-up will be in a different unit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aircast XP Walker bootAlso: Functional BracingAnkle boot allowing weight bearing as tolerated | Device | Functional Bracing |
| Plaster ImmobilisationPlaster immobilisation with no weight bearing allowed. | Device | Plaster Immobilisation |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2014.
- Background: PubMed 17715727Gul 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.
- Background: PubMed 10755435Egol 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.
- Background: PubMed 8636173van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Y Leong, MBChB,MRCS principal investigator
Countess of Chester NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aircast XP Walker boot and Plaster Immobilisation in people with Ankle Fractures and Fracture, run by Countess of Chester NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Y Leong, MBChB, MRCS (01244 365000, wleong@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MOxFQ score (Manchester and Oxford Foot Questionaire (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02160197, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2014.