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Trial registered on ANZCTR

Registration number

ACTRN12616000441415

Ethics application status

Approved

Date submitted

24/03/2016

Date registered

6/04/2016

Date last updated

30/11/2018

Date data sharing statement initially provided

30/11/2018

Type of registration

Retrospectively registered

Titles & IDs

Public title

Buddy Study: Effect of buddy taping vs plaster casts on 5th finger (Boxer's Fractures)

Scientific title

Is minimal intervention as effective as routine immobilisation in adults with an uncomplicated closed neck of 5th metacarpal fracture?

Secondary ID [1]

NIL KNOWN

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

5th metacarpal neck (Boxer) fractures

Condition category

Condition code

Injuries and Accidents

Fractures

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Comparison of traditional plaster casts vs simple buddy taping for 5th metacarpal neck fractures

1. Routine Care Group (Plaster Group): ulnar gutter slab plaster cast in position of safe immobilisation (POSI). This will either be done by the on call plaster technician, or by a doctor, physiotherapist or nurse practitioner. The cast will be changed to a fibreglass cast at 1 week (first fracture clinic) and removed at 3 weeks (second fracture clinic). The patient will be seen again at 6 weeks (third fracture clinic) for repeat X-rays. They will be followed up by phone at 12 weeks.

2. Minimal Intervention Group (Buddy Group): buddy strap between little and ring fingers. This will either be done by the on call plaster technician, or by a doctor, physiotherapist or nurse practitioner. This group will be followed up at 1 and 3 weeks (just review clinics with no further intervention) and at 6 weeks for repeat x-rays. Strapping removed at 3 weeks. They will be followed up at 12 weeks by phone.

For both groups, one of the important functions of the fracture clinic follow up is to allow regular patient review. Also, the patients are being followed up in specific clinics with hand surgeons (Dr Mike Thomas and Prof Randy Bindra) who were involved in the study design.

Intervention code [1]

Treatment: Other

Intervention code [2]

Treatment: Devices

Comparator / control treatment

Control Group is the Plaster Group - this is the current standard of care in our hospital (Gold Coast University and Robina Hospitals) for the management of these injuries.

Control group

Active

Outcomes

Primary outcome [1]

Hand function: Measured using the Shortened Disabilities of the Arm, Shoulder and Hand Outcome Measure (quickDASH). Measured at baseline, 3, 6 and 12 weeks.

Timepoint [1]

quickDASH measured at baseline at presentation to emergency. Then remeasured at 3 and 6 weeks in fracture clinic, and again by phone at 12 weeks (these times reflect time post commencement of intervention).

Secondary outcome [1]

Return to work (days off). Measured in days to return to work

Timepoint [1]

Measured at 1, 3, 6 and 12 weeks post commencement of intervention. Specific question on f/u questionnaire.

Secondary outcome [2]

Health economic analysis - using HPQ measured at 3 and 12 weeks.

Timepoint [2]

3 weeks and 12 weeks post commencement of intervention

Secondary outcome [3]

Grip strength
Objective measurements of strength
Grip strength measured with Jamar dynamometer as per Southampton Protocol.

Timepoint [3]

3 and 6 weeks post commencement of intervention with specific questions on questionnaire at weeks 3 and 6.

Secondary outcome [4]

Patient pain - Visual Analogue Scales 0-10.

Timepoint [4]

12 weeks post commencement of intervention. Measured at each f/u point at 1, 3, 6 and 12 weeks post commencement of intervention.

Secondary outcome [5]

Fracture angulation - X-rays at baseline and at 6 weeks.

Timepoint [5]

Baseline and 6 weeks post commencement of intervention. Angles to be checked by x2 orthopaedic trainees as well as formal radiologists report.

Secondary outcome [6]

EQ-5D-3L assessment of health

Timepoint [6]

measured at baseline and at 12 weeks post commencement of intervention

Secondary outcome [7]

Return to sports and activities

Timepoint [7]

Specific question on f/u questionnaire at 1, 3, 6 and 12 weeks. Measured in days off / days to return to sport / activity

Secondary outcome [8]

Range of motion of hand

Timepoint [8]

Measured at 3 and 6 weeks. Ability to touch fingertips to thenar eminence and thumb to base of little finger. Yes/no answers. Specific questionnaire on f/u at 3 and 6 weeks

Secondary outcome [9]

Patient satisfaction
VAS 0-10

Timepoint [9]

12 weeks post commencement of intervention. Measured at each f/u point at 1, 3, 6 and 12 weeks post commencement of intervention.

Secondary outcome [10]

Fracture healing - measured at 6 weeks on repeat x-ray

Timepoint [10]

Repeat x-ray at 6 weeks to assess fracture healing at this point (6 weeks post intervention).

Eligibility

Key inclusion criteria

A 5th metacarpal neck or Boxer’s fracture is defined as:
Fracture of the neck of 5th metacarpal
Confirmed radiologically in at least 2 planes of view

Minimum age

18 Years

Maximum age

70 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patients less than 18 and over 70 years of age
Open fracture
Rotational deformity
Intra-articular fracture
Communted fracture
Associated tendon injury
Polytrauma – other significant injuries sustained at the time of injury
Unable/Unwilling to consent to study – i.e. intoxicated, dementia
Fracture angulation greater than 70 degrees at initial radiology

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Sequentially numbered opaque envelopes. Upon obtaining consent, consenting clinician opens next envelope in sequence (as generated below) and the patient is either allocated to Buddy or Plaster group. Thus randomised.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computer generated randomised sequence, to either Buddy or Plaster group.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Due to the nature of the intervention, impossible to blind.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

The sample size required for this study is calculated to be 98 patients (49 in each group) over both hospital campuses combined (Southport and Robina Hospital). This sample size was based on the ability to detect a clinically significant difference in the quickDASH (score from 0-100) score of 10 points (with a standard deviation of 20 points) at 1, 3 and 6 weeks with 80% power

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

25/03/2016

Date of last participant enrolment

Anticipated

24/03/2017

Actual

16/10/2017

Date of last data collection

Anticipated

Actual

16/04/2018

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Gold Coast Hospital - Southport

Recruitment hospital [2]

Robina Hospital - Robina

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Gold Coast University Hospital

Address [1]

Gold Coast University Hospital
1 Hospital Boulevard
Southport
QLD 4215

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Emergency Medicine Foundation

Address [2]

1b, 19 Lang Parade
Milton Queensland
Australia 4064

Country [2]

Australia

Primary sponsor type

Hospital

Name

Gold Coast University Hospital

Address

Gold Coast University Hospital

1 Hospital Boulevard
Southport
QLD 4215

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee

Ethics committee address [1]

Gold Coast Hospital Human Research Ethics Committee 
Research Unit Clinical Governance, Education and Research
Gold Coast Hospital and Health Service Queensland Government

Level 2, E Block (PED Building) 
1 Hospital Boulevard 

SOUTHPORT QLD 4215

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

12/01/2016

Approval date [1]

08/02/2016

Ethics approval number [1]

AU/1/3273218

Summary

Brief summary

Metacarpal neck fractures represent the most common hand injury, with 5th metacarpal fractures accounting for the majority   .  Known as Boxer’s Fractures, these injuries are commonly the result of a closed fist strike, and are seen more frequently  in young males, often associated with an aggressive strike, or a fall onto a fist during sporting activities. 
    
Traditionally, 5th metacarpal neck fractures have been managed with closed reduction and cast immobilisation and followed up in an orthopaedic clinic.   However, due to the nature of the injury and then anatomy of the hand musculature, closed reduction often has little benefit in reducing the fracture and improving angulation.  

Moreover, it has been shown that there is no functional deficit in healed fractures with up to 70 degrees of angulation, provided there is no rotational deformity of the fracture fragments .  Several orthopaedic and emergency departments now manage minimally-rotated Boxer’s Fractures with buddy strapping alone, thus encouraging mobilisation and an immediate return to work and activities.

Currently, there is no consensus as to the best management of 5th metacarpal neck fractures.  A previous Cochrane review  found insufficient evidence to recommend a particular management course, but reported no adverse outcomes from simple buddy strapping.  More recently, a study comparing closed reduction and plaster, with buddy strapping and soft wrap, suggested no adverse outcome to strapping, and a significant improvement on time to return to work for the buddy strapping group.  

The patient demographic associated with Boxer’s Fractures (young, male, working) historically have a suboptimal compliance with follow up.   In one study, 10% of patients removed splints themselves and never returned to follow up.   If these injuries can be managed with minimal intervention and community follow up, time would be saved in both the emergency department and orthopaedic outpatients, with a concurrent economic benefit.  

We propose a prospective, randomised study to assess outcomes of 5th metacarpal neck fractures (Boxer’s Fracture).  The proposed study will compare minimal intervention (buddy strapping of ring and little fingers) with current practice; plaster cast in position of safe immobilisation (POSI).  This study aims to provide an answer to the question regarding the best management of these fractures.

Trial website

Trial related presentations / publications

Public notes

In kind costs covered by research department.  Actual cost of interventions negligible as current practice and standard of care.  

Trainee grant will be sought for statistical analysis (not yet applied for). 
 
Note recruitment started day after initial submission of ANZCTR registration.  Researcher was not aware that this had to be done 3 weeks prior!

Contacts

Principal investigator

Name

Dr Richard Pellatt

Address

Gold Coast University Hospital Emergency Department
1 Hospital Boulevard
Southport
4215
QLD

Country

Australia

Phone

+61 431620030

Fax

[email protected]

Contact person for public queries

Name

Richard Pellatt

Address

Gold Coast University Hospital Emergency Department
1 Hospital Boulevard
Southport
4215
QLD

Country

Australia

Phone

+61 431620030

Fax

[email protected]

Contact person for scientific queries

Name

Richard Pellatt

Address

Gold Coast University Hospital Emergency Department
1 Hospital Boulevard
Southport
4215
QLD

Country

Australia

Phone

+61 431620030

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Is Buddy Taping as Effective as Plaster Immobilization for Adults With an Uncomplicated Neck of Fifth Metacarpal Fracture? A Randomized Controlled Trial	2019	https://doi.org/10.1016/j.annemergmed.2019.01.032

N.B. These documents automatically identified may not have been verified by the study sponsor.

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