Condition category
Injury, Occupational Diseases, Poisoning
Date applied
16/04/2014
Date assigned
12/05/2014
Last edited
05/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Fractures of the clavicle (broken collarbone) are very common. They represent approximately 2.6% of all skeletal injuries (fracture of the middle third of the clavicle responsible for 80% to 85% of all clavicle fractures). Very often this type of fracture is associated with some deviation caused by muscle insertions. Nonsurgical treatment of clavicle fractures with a figure-of-eight bandage or sling has been used for years with excellent results and low complication rates. However, some recent studies have questioned these results especially in cases of fracture with some bone displacement and shortening. Shortening of the clavicle is linked to decreased strength and range of motion. Some studies have demonstrated a relationship between shortening and loss of strength and worse functional outcomes and recommend surgical treatment in case where shortening is greater than 2 cms. Other studies report good functional outcome and low complication rates in patients that have undergone conservative treatment (figure-of-eight bandage or sling) even when the clavicle is shortened.
It is not clear whether clavicle shortening affects upper limb function. The aim of this study is to assess the relationship between shortening of the clavicle after conservative treatment with figure-of-eight bandage and upper limb function by observing a number of patients.

Who can participate?
Patients aged 18 and over, with a fracture of the middle third of the clavicle.

What does the study involve?
We looked at 59 patients with clavicle fractures (recruited sequentially) from the Discipline of Hand and Upper Limb Surgery at São Paulo Federal University (UNIFESP). All patients were treated with a non-surgical standard care figure-of-eight bandage for a minimum of six weeks until clinical and radiological healing of the fracture was observed. In the first evaluation, the length of both clavicles was measured on a single anteroposterior radiograph. The degree of shortening was calculated as the difference between the lengths of the two clavicles. During treatment with a figure-of-eight bandage, the function of the affected upper limb was released as tolerated. Each patient underwent rehabilitation from the sixth week onward, and the rehabilitation was similar to that for any patient undergoing physiotherapeutic rehabilitation, with exercises to increase range of motion and passive, active, and progressive strength. Participants answered 30 questions concerning the level of difficulty in completing everyday tasks, and pain during and after the treatment.

What are the possible benefits and risks of participating?
All patients receive standard care. There is no benefit in participating. Risks are related to the treatment and the type of fracture such as non-union (fracture area has not healed), malunion (fracture heals out of position it was set) in and cosmetic deformity in the shoulder by the consolidation.

Where is the study run from?
Discipline of Hand and Upper Limb Surgery at São Paulo Federal University (UNIFESP).

When is the study starting and how long is it expected to run for?
January 2010 to June 2012

Who is funding the study?
UNIFESP (São Paulo Federal University), Brazil

Who is the main contact?
Dr Gustavo Santiago de Lima Figueiredo

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gustavo Figueiredo

ORCID ID

Contact details

Avenida Doutor Altino Arantes n. 895
São Paulo
04042-034
Brazil

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Correlation of the degree of clavicle shortening after non-surgical treatment of midshaft fractures with upper limb function: a prospective cohort single-centre study

Acronym

Study hypothesis

We developed this study to assess the relationship between shortening of the clavicle after conservative treatment with figure-of-eight bandage and upper limb function, hypothesising that there is no relationship between shortening and functional deficit.

Ethics approval

CEP UNIFESP - Plataforma Brasil (Center for Ethics in Research of the Federal University of São Paulo - Brazil platform), 08/02/2013, approval number 192248, protocol number 11376613.2.0000.5505.

Study design

Prospective cohort single-centre study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Clavicle fracture

Intervention

At the time of diagnosis all patients were treated with a non-surgically standard care figure-of-eight bandage (a type of immobilization to this kind of fracture), for a minimum of 6 weeks until clinical and radiological healing of the fracture was observed. During treatment with a figure-of-eight bandage, the function of the affected upper limb was released as tolerated. Each patient underwent rehabilitation from the sixth week onward, and the rehabilitation was similar for all with physiotherapeutic rehabilitation, starting with exercises to increase range of motion and passive, active and progressive strength gain.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The primary clinical outcome was measured using the Disability of Arm, Hand and Shoulder (DASH) score revalidated for Portuguese language, consisting of 30 questions concerning the level of difficulty in completing everyday tasks, and the visual analogue scale (VAS), score (0 = no pain, 10 = unbearable pain), both applied in the 6 weeks and 1 year consultations, and compared to the clavicle shortening in the first evaluation (the length of both clavicles was measured on a single anteroposterior radiograph from the centre of the sternoclavicular joint to the centre of the acromioclavicular joint; the degree of shortening was calculated as the difference between the lengths of the two clavicles)

Secondary outcome measures

As secondary outcomes we examined the association of the objective variables age, sex (male/female), and affected limb (right/left) with the dichotomous, subjective variables of occupation, cause of trauma (high/low energy), aesthetic satisfaction (satisfied/not satisfied), and occurrence of complications (type of complication and frequency)

Overall trial start date

20/01/2010

Overall trial end date

01/05/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Patients aged 18 and older diagnosed with a fracture of the middle third of the clavicle

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

65

Participant exclusion criteria

1. Neurological and vascular deficits
2. Open fractures
3. Associated fracture in the upper limb
4. Bilateral fractures
5. Clavicle fractures with bone contact
6. Passage of more than 14 days since fracture
7. Previous surgery
8. Chronic disease in the affected limb

Recruitment start date

20/01/2010

Recruitment end date

01/05/2012

Locations

Countries of recruitment

Brazil

Trial participating centre

Avenida Doutor Altino Arantes n. 895
São Paulo
04042-034
Brazil

Sponsor information

Organisation

São Paulo Federal University (Brazil)

Sponsor details

Rua Borges Lagoa n. 778
São Paulo
04042-034
Brazil

Sponsor type

University/education

Website

https://www.unifesp.br/

Funders

Funder type

University/education

Funder name

São Paulo Federal University (Brazil)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26080806

Publication citations

Additional files

Editorial Notes

05/02/2016: Publication reference added.