Closed Fracture of Base of Fifth Metatarsal BoneNCT01592604
An Optimal Treatment for Avulsion Fractures of the Base of Fith Metatarsal Bone
A study testing Compressive bandage and Below knee walking cast in people with Closed Fracture of Base of Fifth Metatarsal Bone, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Avulsion fractures of the base (tuberosity) of fifth metatarsal bone are the most common fractures in the foot, frequently treated in fracture clinics and involving significant resources. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Closed Fracture of Base of Fifth Metatarsal Bone
- What is being tested?
- Compressive bandage and Below knee walking cast
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2011to Aug 2013
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult patients (older than 15 years of age) with an acute closed isolated type I avulsion fractures of the base of the fifth metatarsal bone, (within 7 days of the injury)
Who cannot join
- Diabetes, Inflammatory arthritis, previous same foot tarso-metatarsal fractures, previous same foot surgery, more than 7 days since the injury.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northern General Hospital
Sheffield, South Yorkshire, S5 7AU
About this study
Official title: An Optimal Treatment for Avulsion Fractures of the Base of Fith Metatarsal Bone. A Level I Prospective Randomised Control Trial
Avulsion fractures of the base (tuberosity) of fifth metatarsal bone are the most common fractures in the foot, frequently treated in fracture clinics and involving significant resources. At present methods of treatment and follow up vary widely from no active treatment to surgery, depending entirely on a treating doctor preference. There is no agreement on simple, safe and reliable method of treatment. The investigators believe that vast majority of these injuries heal well on its own without any specific treatment. By comparing two most commonly used treatments the investigators aim to establish one simple, safe and reliable mode of treatments. The investigators are going to evaluate functional results of these two treatments in a short and longer time prospective, by using the best available scientific tools. The investigators believe that results of the investigators study will eventually lead to change of practise and more efficient NHS care for these patients. It will reduce unnecessary treatments and clinic appointments, and bring substantial savings to the NHS in a long prospective.
Read the detailed description
This is a randomised prospective control trial. Patients with these fractures will normally first come to the Emergency Department (ED), where they have a foot radiograph confirming a fracture, and initial treatment only. This treatment is arbitrary, depends on the assessing clinician preference and usually varies from supportive tight bandage or a supportive plaster cast with crutches. All of these patients are normally referred to an orthopaedic fracture clinic. It is an orthopaedic trauma clinician in the fracture clinic who determines and takes the responsibility for the definitive management of patients with this injuries and may decide to change the treatment initiated by the ED staff.
The investigators will inform clinical staff in the ED of the trial.The investigators will provide ED clinicians with patient information sheets. Patients who have this information sheet provided by the ED will have between a few hours and more than 24 hours "cool off" period to consider the information depending on next fracture clinic availability. Then they will be recruited in the fracture clinic should they wish to participate. The investigators must stress, however, that due to the nature of the ED service - high staff turn around, time pressure and other reasons beyond our control it is not possible to guarantee that all patients with relevant injuries will receive an information sheet in ED and have this "cool off" period to consider participation in. In such situations patients will be offered the information sheet, counselled and recruited, if they wish to, on their first presentation to the fracture clinic. The investigators believe that due to practical issues related to ED service this will be the likely situation for a significant proportion of patients. The investigators think this is an unavoidable situation.
Patients will be recruited on their first presentation to a fracture clinic should they consent. Using centralised electronic remote randomisation method patients will be allocated either to group A(symptomatic treatment)- double tubigrip and crutches with recommendation to weight bear as comfortable in normal footwear, or group B (active treatment) - below knee walking plaster cast with crutches and recommendation to weight bear as comfortable. This means that for many patients the initial treatment they received in ED will be changed but this often happens in normal current practice. Two treatment modes used in our study - supportive bandage and walking cast are the ones most commonly used normally. Patients declining to participate in the study will be treated and followed up according to patient and treating clinician preference and this also reflects the current practice. This study therefore deviates little from the current common practice. Patients in group B will be evaluated for venous thrombo-embolism (VTE) risk according to Sheffield Teaching Hospitals NHS Foundation Trust policy. Those whose risk is high will be offered anti-thrombotic prophylaxis according to the Trust policy for the duration of cast immobilization (4 weeks). Those patients will be counselled on benefits and risks of anti-thrombotic prophylaxis. On the whole we do not anticipate many patients to require anti-thrombotic prophylaxis.
Outcome measures: Primary outcome - foot functional outcome. We will use a Visual -Analogue-Scale Foot and Ankle (VAS FA) score. This is the only validated functional foot and ankle score. Secondary outcome - A) Health status and functional outcome, - Euroqol (EQ- 5D) - a standardised instrument for use as a measure of a health outcome and B) - foot function - American Foot and Ankle Society Foot and Ankle functional (AOFAS) score. This foot and ankle score is not validated, but most frequently used in the research literature. Additional outcomes will be records of unexpected return with the same problem, change of treatment modality, re-injury of the same foot and complications of treatment. The investigators will evaluate outcomes at four time points. Firstly, patients will complete baseline VAS FA, AOFAS, and EQ-5D questinnaires providing the level of functional impairment/disability prior to treatment. Patients in both groups will be seen in clinic at 4 weeks - at this stage cast will be removed in group B. At this point VAS FA, AOFAS, and EQ-5D questionnaires will be filled by patients in both groups in clinic. To see whether method of treatment has an effect in longer prospective the investigators will evaluate outcomes at 3 and 6 months. We anticipate that by this time fractures will heal uneventfully in the vast majority of patients . We believe that majority of patients is unlikely to return to clinic after such a long time. For this reason the investigators will post questionnaires to patients in both groups to be filled at home and posted back to us in confidential prepaid envelopes one week before their respective 3 and 6 month follow up. If a patient will decide to withdraw, or we have no response, - no further attempts to contact will be made. The investigators believe that this will save unnecessary follow up appointments, and also yield more results. In case of any problems all patients will be able to return to a fracture clinic for a help. The investigators will ask all patients in both groups to stop using crutches whenever they feel like to.
- Being tested
- Compressive bandage, Below knee walking cast
- Keywords
- fracture, fifth metatarsal, functioanl outcome
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compressive bandageDevice
Compressive below knee bandage for 4 weeks in group A
Below knee walking castDevice
Below knee walking cast for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Patients receive supportive compressive bandage for 4 weeks Receives: Device: Compressive bandage |
| Treatment B | Experimental | Below knee walking plaster cast for 4 weeks Receives: Device: Below knee walking cast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validated Visual analague scale for foot and ankle (VAS FA) score
To evaluate functional outcome 6 months post treatment
Measured: 6 months post treatment
Secondary outcomes (1)
Euroqol 5D
Standardised general health functional outcome measure
Measured: baseline, 4 weeks, 3 months, 6 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2012 (estimated)
- Study startNov 2011
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Closed Fracture of Base of Fifth Metatarsal BoneStudies 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
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pavel - Akimau, MBChB, Principal investigator, Sheffield Teaching Hopsitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01592604
- Sponsor's protocol ID
- STH 15761
- Status last verified
- Aug 2013
- First submitted
- 5 Apr 2012
- Last updated
- 26 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Optimal Treatment for Avulsion Fractures of the Base of Fith Metatarsal Bone. A Level I Prospective Randomised Control Trial
- ClinicalTrials.gov ID
- NCT01592604
- Acronym / sponsor ID
- STH 15761
- Keywords
- fracture, fifth metatarsal, functioanl outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 7 May 2012 (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.
Avulsion fractures of the base (tuberosity) of fifth metatarsal bone are the most common fractures in the foot, frequently treated in fracture clinics and involving significant resources. At present methods of treatment and follow up vary widely from no active treatment to surgery, depending entirely on a treating doctor preference. There is no agreement on simple, safe and reliable method of treatment. The investigators believe that vast majority of these injuries heal well on its own without any specific treatment. By comparing two most commonly used treatments the investigators aim to establish one simple, safe and reliable mode of treatments. The investigators are going to evaluate functional results of these two treatments in a short and longer time prospective, by using the best available scientific tools. The investigators believe that results of the investigators study will eventually lead to change of practise and more efficient NHS care for these patients. It will reduce unnecessary treatments and clinic appointments, and bring substantial savings to the NHS in a long prospective.
Detailed description
This is a randomised prospective control trial. Patients with these fractures will normally first come to the Emergency Department (ED), where they have a foot radiograph confirming a fracture, and initial treatment only. This treatment is arbitrary, depends on the assessing clinician preference and usually varies from supportive tight bandage or a supportive plaster cast with crutches. All of these patients are normally referred to an orthopaedic fracture clinic. It is an orthopaedic trauma clinician in the fracture clinic who determines and takes the responsibility for the definitive management of patients with this injuries and may decide to change the treatment initiated by the ED staff.
The investigators will inform clinical staff in the ED of the trial.The investigators will provide ED clinicians with patient information sheets. Patients who have this information sheet provided by the ED will have between a few hours and more than 24 hours "cool off" period to consider the information depending on next fracture clinic availability. Then they will be recruited in the fracture clinic should they wish to participate. The investigators must stress, however, that due to the nature of the ED service - high staff turn around, time pressure and other reasons beyond our control it is not possible to guarantee that all patients with relevant injuries will receive an information sheet in ED and have this "cool off" period to consider participation in. In such situations patients will be offered the information sheet, counselled and recruited, if they wish to, on their first presentation to the fracture clinic. The investigators believe that due to practical issues related to ED service this will be the likely situation for a significant proportion of patients. The investigators think this is an unavoidable situation.
Patients will be recruited on their first presentation to a fracture clinic should they consent. Using centralised electronic remote randomisation method patients will be allocated either to group A(symptomatic treatment)- double tubigrip and crutches with recommendation to weight bear as comfortable in normal footwear, or group B (active treatment) - below knee walking plaster cast with crutches and recommendation to weight bear as comfortable. This means that for many patients the initial treatment they received in ED will be changed but this often happens in normal current practice. Two treatment modes used in our study - supportive bandage and walking cast are the ones most commonly used normally. Patients declining to participate in the study will be treated and followed up according to patient and treating clinician preference and this also reflects the current practice. This study therefore deviates little from the current common practice. Patients in group B will be evaluated for venous thrombo-embolism (VTE) risk according to Sheffield Teaching Hospitals NHS Foundation Trust policy. Those whose risk is high will be offered anti-thrombotic prophylaxis according to the Trust policy for the duration of cast immobilization (4 weeks). Those patients will be counselled on benefits and risks of anti-thrombotic prophylaxis. On the whole we do not anticipate many patients to require anti-thrombotic prophylaxis.
Outcome measures: Primary outcome - foot functional outcome. We will use a Visual -Analogue-Scale Foot and Ankle (VAS FA) score. This is the only validated functional foot and ankle score. Secondary outcome - A) Health status and functional outcome, - Euroqol (EQ- 5D) - a standardised instrument for use as a measure of a health outcome and B) - foot function - American Foot and Ankle Society Foot and Ankle functional (AOFAS) score. This foot and ankle score is not validated, but most frequently used in the research literature. Additional outcomes will be records of unexpected return with the same problem, change of treatment modality, re-injury of the same foot and complications of treatment. The investigators will evaluate outcomes at four time points. Firstly, patients will complete baseline VAS FA, AOFAS, and EQ-5D questinnaires providing the level of functional impairment/disability prior to treatment. Patients in both groups will be seen in clinic at 4 weeks - at this stage cast will be removed in group B. At this point VAS FA, AOFAS, and EQ-5D questionnaires will be filled by patients in both groups in clinic. To see whether method of treatment has an effect in longer prospective the investigators will evaluate outcomes at 3 and 6 months. We anticipate that by this time fractures will heal uneventfully in the vast majority of patients . We believe that majority of patients is unlikely to return to clinic after such a long time. For this reason the investigators will post questionnaires to patients in both groups to be filled at home and posted back to us in confidential prepaid envelopes one week before their respective 3 and 6 month follow up. If a patient will decide to withdraw, or we have no response, - no further attempts to contact will be made. The investigators believe that this will save unnecessary follow up appointments, and also yield more results. In case of any problems all patients will be able to return to a fracture clinic for a help. The investigators will ask all patients in both groups to stop using crutches whenever they feel like to.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Device: Compressive bandagePatients receive supportive compressive bandage for 4 weeks |
| Treatment B | Experimental | Device: Below knee walking castBelow knee walking plaster cast for 4 weeks |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (older than 15 years of age) with an acute closed isolated type I avulsion fractures of the base of the fifth metatarsal bone, (within 7 days of the injury)
Key exclusion criteria (1 listed)
- Diabetes, Inflammatory arthritis, previous same foot tarso-metatarsal fractures, previous same foot surgery, more than 7 days since the injury.
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 |
|---|---|---|
| Compressive bandageCompressive below knee bandage for 4 weeks in group A | Device | Treatment A |
| Below knee walking castBelow knee walking cast for 4 weeks | Device | Treatment B |
Primary outcome
Validated Visual analague scale for foot and ankle (VAS FA) score
Time frame: 6 months post treatment
To evaluate functional outcome 6 months post treatment
1 secondary outcome
Euroqol 5D
Time frame: baseline, 4 weeks, 3 months, 6 months post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
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.
Pavel - Akimau, MBChB principal investigator
Sheffield Teaching Hopsitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compressive bandage and Below knee walking cast in people with Closed Fracture of Base of Fifth Metatarsal Bone, run by Sheffield Teaching Hospitals 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 26 Aug 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validated Visual analague scale for foot and ankle (VAS FA) score (time frame: 6 months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2013.