Fracture of ClavicleNCT02398006
Conservative Interventions for Treating Clavicle Fractures in Adults
A study testing a standard arm sling and a figure-of-eight bandage in people with Fracture of Clavicle, run by Hospital Israelita Albert Einstein.
Trial summary
Background: Fracture of the clavicle is common accounting for 2.6% to 4 % of all fractures, with an overall incidence of 36.5 to 64 per 100,000 per year. Around 80% of clavicle fractures occur in the middle third of the clavicle. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fracture of Clavicle
- What is being tested?
- a standard arm sling and a figure-of-eight bandage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Dec 2017
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older and 65 years or less with middle third clavicle fracture,
- Acute fracture (less than 10 days), we will include all types of middle third clavicle fractures (non-displaced and displaced fractures),
- No medical contraindication to proposed methods of immobilisation,
- Understanding of Portuguese language and written informed consent.
Who cannot join
- Pathological fracture,
- Open fracture,
- Neurovascular injury on physical examination,
- Associated head injury (Glasgow Coma Scale score of <12),
- Ipsilateral upper limb fractures and/or dislocation(except hand and fingers),
- History of frozen shoulder,
- Previous disease in the limb that could influence the results (e.g. rheumatoid arthritis),
- Inability to comply with follow-up (inability to read or complete forms).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Figure-of-eight Bandage Versus Arm Sling for Treating Middle Third Clavicle Fractures in Adults: Study Protocol for a Randomised Controlled Trial
Background: Fracture of the clavicle is common accounting for 2.6% to 4 % of all fractures, with an overall incidence of 36.5 to 64 per 100,000 per year. Around 80% of clavicle fractures occur in the middle third of the clavicle. There is a lack of evidence of randomised controlled trials assessing the best treatment of these fractures. The objective of this study is to evaluate the effects (benefits and harms) of conservative interventions: figure-of-eight bandage versus sling for the treating middle third clavicle fractures. Methods/Design: this project has been designed as a single-centre, parallel-group randomised controlled trial that will compare figure-of-eight bandage versus sling. The investigators aim to recruit 110 adults, aged 18 years or older, with an acute (less than 10 days) middle third clavicle fracture. Primary outcomes will be function or disability measured by DASH questionnaire; the secondary outcomes will be: modified UCLA score pain, treatment failure, adverse events and numbers returning to previous activities. Data analysis: the chi-square test will be used to analyse the results of categorical variables, and Student t-test will be used to compare groups with respect to the numerical variables. The Student t-test is used to compare the clinical outcome of each group at 1, 2 and 4 weeks and at 6 and 12 months after the intervention. The significance level of 5% (alpha = 0.05) is used for all statistical tests such that tests have a value of less than 0.05 are considered statistically significant. Discussion: According to current evidence there is very limited evidence from two single trials only regarding the effectiveness of different methods of conservative interventions for treating clavicle fractures. This study is one of the first randomised controlled trials following the CONSORT statements designed to compare two conservative methods for treating clavicle fractures (figure-of-eight versus sling).
Read the detailed description
Whilst there are several options for conservative treatment for middle third clavicle fractures, only two randomised controlled published in the 80s attempted to determine the effects of different methods for conservative treatment for middle third clavicle fractures. Thus, a pragmatic trial design has been chosen as it can directly inform clinical practice; our inclusion criteria will reflect the variety in patient presentations that would be encountered by general orthopaedic surgeons in the clinical setting. The current trial includes design characteristics known to minimise bias. Participants will be assigned using a concealed random procedure, assessments and data analysis will be blinded and we will use the intention-to-treat analysis.
- Conditions
- Fracture of Clavicle
- Being tested
- a standard arm sling, a figure-of-eight bandage
- Keywords
- Clavicle [mh], Fracture Healing [mh], Fractures, Bone [mh], Treatment outcome [mh], Conservative treatment [tw]
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a standard arm slingOther
Closed reduction (re-aligning the fragments of the fracture) will be not performed because the reduced position is practically impossible to maintain.
a figure-of-eight bandageOther
Closed reduction (re-aligning the fragments of the fracture) will be not performed because the reduced position is practically impossible to maintain.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: a standard arm sling | Active comparator | Group 1: the orthopaedic surgeon will apply a standard arm sling that will be used for four weeks; however, during these weeks, participants will be encouraged to discard the sling when their pain has subsided. After four weeks the same orientations of group 1 will be done to this group. Receives: Other: a standard arm sling |
| Group 2: a figure-of-eight bandage | Active comparator | Group 2: a figure-of-eight bandage will be used for four weeks, and every week the participants will return to check and adjust the immobilisation. In this way, the dominant hand can remain free and simple activities will be allowed (writing, keyboarding and other). After four weeks, participants will be encouraged to discard the bandage, but load bearing will not be allowed before osseous consolidation (around 10 weeks). Receives: Other: a figure-of-eight bandage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Function or disability will be measured by DASH - Disability of the Arm, Shoulder, and Hand questionnaire
Function or disability will be measured by DASH - Disability of the Arm, Shoulder, and Hand questionnaire validated and translated into Portuguese in Brazil, the final score of the DASH questionnaire will be converted to a percentage via the following formula: Scoring = [Sum of answers n/n - 1] X 25, where n is the number of complete answers. The two optional modules will not be measured. The value obtained will be directly proportional to the percentage of impairment of the limb function.
Measured: 12 months
Secondary outcomes (5)
Modified University of California at Los Angeles (modified - UCLA)
Modified University of California at Los Angeles (modified - UCLA), validated and translated into Portuguese in Brazil.
Measured: 12 months
Pain measured on a 0 to 100 using visual analogue scale (VAS)
Pain measured on a 0 to 100 using visual analogue scale (VAS) (with 0 indicating no pain and 100 indicating the maximum pain). As reported in the literature, a clinically important change will be considered as a 30% or more change in pain score.
Measured: 12 months
Treatment failure measured by the number of participants who have undergone or are being considered a surgical intervention
Treatment failure measured by the number of participants who have undergone or are being considered a surgical intervention (e.g. symptomatic non-union or malunion with intractable pain). Although studies evaluating patients with fractures without displacement reported low rates of nonunion (about 0.03%), studies with patients with displaced fractures found nonunion rates of up to 15%. Therefore, we expect between 5 and 10% of our participants might provide symptomatic nonunion during follow-up. Patients who experience this complication during follow-up study will be treated surgically with open reduction and internal fixation with pre-contoured locking plate counted down the superior surface of the clavicle and bone grafting when necessary.
Measured: 12 months
Adverse events
Adverse events measured by: a) Cosmetic result: perception of deformity or asymmetric result (dichotomous data); b) Asymptomatic non-union (i.e. the fracture has not healed radiographically with no pain); c) Stiffness/restricted of range of shoulder movement (compared with contralateral side).
Measured: 12 months
Numbers returning to previous activities (work, sport, activities of daily living), including time to return.
Numbers returning to previous activities (work, sport, activities of daily living), including time to return.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionSep 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fracture of ClavicleStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Lenza, Hospital Israelita Albert Einstein
- Investigators
- Mario Lenza, PhD, Principal investigator, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02398006
- Sponsor's protocol ID
- HIAE orthopaedics
- Status last verified
- Mar 2015
- First submitted
- 12 Mar 2015
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lenza M, Taniguchi LF, Ferretti M. Figure-of-eight bandage versus arm sling for treating middle-third clavicle fractures in adults: study protocol for a randomised controlled trial. Trials. 2016 May 4;17(1):229. doi: 10.1186/s13063-016-1355-8.
PubMed 27142768
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Figure-of-eight Bandage Versus Arm Sling for Treating Middle Third Clavicle Fractures in Adults: Study Protocol for a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02398006
- Acronym / sponsor ID
- HIAE orthopaedics
- Conditions
- Fracture of Clavicle
- Keywords
- Clavicle [mh], Fracture Healing [mh], Fractures, Bone [mh], Treatment outcome [mh], Conservative treatment [tw]
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 25 Mar 2015 (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.
Background: Fracture of the clavicle is common accounting for 2.6% to 4 % of all fractures, with an overall incidence of 36.5 to 64 per 100,000 per year. Around 80% of clavicle fractures occur in the middle third of the clavicle. There is a lack of evidence of randomised controlled trials assessing the best treatment of these fractures. The objective of this study is to evaluate the effects (benefits and harms) of conservative interventions: figure-of-eight bandage versus sling for the treating middle third clavicle fractures. Methods/Design: this project has been designed as a single-centre, parallel-group randomised controlled trial that will compare figure-of-eight bandage versus sling. The investigators aim to recruit 110 adults, aged 18 years or older, with an acute (less than 10 days) middle third clavicle fracture. Primary outcomes will be function or disability measured by DASH questionnaire; the secondary outcomes will be: modified UCLA score pain, treatment failure, adverse events and numbers returning to previous activities. Data analysis: the chi-square test will be used to analyse the results of categorical variables, and Student t-test will be used to compare groups with respect to the numerical variables. The Student t-test is used to compare the clinical outcome of each group at 1, 2 and 4 weeks and at 6 and 12 months after the intervention. The significance level of 5% (alpha = 0.05) is used for all statistical tests such that tests have a value of less than 0.05 are considered statistically significant. Discussion: According to current evidence there is very limited evidence from two single trials only regarding the effectiveness of different methods of conservative interventions for treating clavicle fractures. This study is one of the first randomised controlled trials following the CONSORT statements designed to compare two conservative methods for treating clavicle fractures (figure-of-eight versus sling).
Detailed description
Whilst there are several options for conservative treatment for middle third clavicle fractures, only two randomised controlled published in the 80s attempted to determine the effects of different methods for conservative treatment for middle third clavicle fractures. Thus, a pragmatic trial design has been chosen as it can directly inform clinical practice; our inclusion criteria will reflect the variety in patient presentations that would be encountered by general orthopaedic surgeons in the clinical setting. The current trial includes design characteristics known to minimise bias. Participants will be assigned using a concealed random procedure, assessments and data analysis will be blinded and we will use the intention-to-treat analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: a standard arm sling | Active comparator | Other: a standard arm slingGroup 1: the orthopaedic surgeon will apply a standard arm sling that will be used for four weeks; however, during these weeks, participants will be encouraged to discard the sling when their pain has subsided. After four weeks the same orientations of group 1 will be done to this group. |
| Group 2: a figure-of-eight bandage | Active comparator | Other: a figure-of-eight bandageGroup 2: a figure-of-eight bandage will be used for four weeks, and every week the participants will return to check and adjust the immobilisation. In this way, the dominant hand can remain free and simple activities will be allowed (writing, keyboarding and other). After four weeks, participants will be encouraged to discard the bandage, but load bearing will not be allowed before osseous consolidation (around 10 weeks). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older and 65 years or less with middle third clavicle fracture,
- Acute fracture (less than 10 days), we will include all types of middle third clavicle fractures (non-displaced and displaced fractures),
- No medical contraindication to proposed methods of immobilisation,
- Understanding of Portuguese language and written informed consent.
Key exclusion criteria (8 listed)
- Pathological fracture,
- Open fracture,
- Neurovascular injury on physical examination,
- Associated head injury (Glasgow Coma Scale score of <12),
- Ipsilateral upper limb fractures and/or dislocation(except hand and fingers),
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 |
|---|---|---|
| a standard arm slingClosed reduction (re-aligning the fragments of the fracture) will be not performed because the reduced position is practically impossible to maintain. | Other | Group 1: a standard arm sling |
| a figure-of-eight bandageClosed reduction (re-aligning the fragments of the fracture) will be not performed because the reduced position is practically impossible to maintain. | Other | Group 2: a figure-of-eight bandage |
Primary outcome
Function or disability will be measured by DASH - Disability of the Arm, Shoulder, and Hand questionnaire
Time frame: 12 months
Function or disability will be measured by DASH - Disability of the Arm, Shoulder, and Hand questionnaire validated and translated into Portuguese in Brazil, the final score of the DASH questionnaire will be converted to a percentage via the following formula: Scoring = [Sum of answers n/n - 1] X 25, where n is the number of complete answers. The two optional modules will not be measured. The value obtained will be directly proportional to the percentage of impairment of the limb function.
5 secondary outcomes
Modified University of California at Los Angeles (modified - UCLA)
Time frame: 12 months
Pain measured on a 0 to 100 using visual analogue scale (VAS)
Time frame: 12 months
Treatment failure measured by the number of participants who have undergone or are being considered a surgical intervention
Time frame: 12 months
Adverse events
Time frame: 12 months
Numbers returning to previous activities (work, sport, activities of daily living), including time to return.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
- Derived from this study: PubMed 27142768Lenza M, Taniguchi LF, Ferretti M. Figure-of-eight bandage versus arm sling for treating middle-third clavicle fractures in adults: study protocol for a randomised controlled trial. Trials. 2016 May 4;17(1):229. doi: 10.1186/s13063-016-1355-8.
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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.
Mario Lenza, PhD principal investigator
Hospital Israelita Albert Einstein
Questions about this trial
What is this clinical trial studying?
A study testing a standard arm sling and a figure-of-eight bandage in people with Fracture of Clavicle, run by Hospital Israelita Albert Einstein.
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 4 inclusion and 8 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 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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 Mario Lenza, PhD (55 11 21511444, mario.lenza@einstein.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Function or disability will be measured by DASH - Disability of the Arm, Shoulder, and Hand questionnaire (time frame: 12 months). 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 NCT02398006, which also lists 1 linked publication.
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 25 Mar 2015.