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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
Date results information 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] 288841 0
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 298123 0
Condition category
Condition code
Injuries and Accidents 298293 298293 0 0
Fractures
Musculoskeletal 298315 298315 0 0
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] 294297 0
Treatment: Other
Intervention code [2] 294320 0
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] 297773 0
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] 297773 0
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] 322173 0
Return to work (days off). Measured in days to return to work
Timepoint [1] 322173 0
Measured at 1, 3, 6 and 12 weeks post commencement of intervention. Specific question on f/u questionnaire.
Secondary outcome [2] 322174 0
Health economic analysis - using HPQ measured at 3 and 12 weeks.
Timepoint [2] 322174 0
3 weeks and 12 weeks post commencement of intervention
Secondary outcome [3] 322175 0
Grip strength
Objective measurements of strength
Grip strength measured with Jamar dynamometer as per Southampton Protocol.
Timepoint [3] 322175 0
3 and 6 weeks post commencement of intervention with specific questions on questionnaire at weeks 3 and 6.
Secondary outcome [4] 322176 0
Patient pain - Visual Analogue Scales 0-10.
Timepoint [4] 322176 0
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] 322177 0
Fracture angulation - X-rays at baseline and at 6 weeks.
Timepoint [5] 322177 0
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] 322259 0
EQ-5D-3L assessment of health
Timepoint [6] 322259 0
measured at baseline and at 12 weeks post commencement of intervention
Secondary outcome [7] 322358 0
Return to sports and activities
Timepoint [7] 322358 0
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] 322359 0
Range of motion of hand
Timepoint [8] 322359 0
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] 322360 0
Patient satisfaction
VAS 0-10
Timepoint [9] 322360 0
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] 322361 0
Fracture healing - measured at 6 weeks on repeat x-ray
Timepoint [10] 322361 0
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
Gender
Both males and females
Can healthy volunteers participate?
No
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 5484 0
Gold Coast Hospital - Southport
Recruitment hospital [2] 5524 0
Robina Hospital - Robina

Funding & Sponsors
Funding source category [1] 293198 0
Hospital
Name [1] 293198 0
Gold Coast University Hospital
Address [1] 293198 0


Gold Coast University Hospital
1 Hospital Boulevard
Southport
QLD 4215
Country [1] 293198 0
Australia
Funding source category [2] 301328 0
Charities/Societies/Foundations
Name [2] 301328 0
Emergency Medicine Foundation
Address [2] 301328 0
1b, 19 Lang Parade
Milton Queensland
Australia 4064
Country [2] 301328 0
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] 292002 0
None
Name [1] 292002 0
Address [1] 292002 0
Country [1] 292002 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294684 0
Human Research Ethics Committee
Ethics committee address [1] 294684 0
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] 294684 0
Australia
Date submitted for ethics approval [1] 294684 0
12/01/2016
Approval date [1] 294684 0
08/02/2016
Ethics approval number [1] 294684 0
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 64630 0
Dr Richard Pellatt
Address 64630 0
Gold Coast University Hospital Emergency Department
1 Hospital Boulevard
Southport
4215
QLD
Country 64630 0
Australia
Phone 64630 0
+61 431620030
Fax 64630 0
Email 64630 0
rafpellatt@gmail.com
Contact person for public queries
Name 64631 0
Dr Richard Pellatt
Address 64631 0
Gold Coast University Hospital Emergency Department
1 Hospital Boulevard
Southport
4215
QLD
Country 64631 0
Australia
Phone 64631 0
+61 431620030
Fax 64631 0
Email 64631 0
rafpellatt@gmail.com
Contact person for scientific queries
Name 64632 0
Dr Richard Pellatt
Address 64632 0
Gold Coast University Hospital Emergency Department
1 Hospital Boulevard
Southport
4215
QLD
Country 64632 0
Australia
Phone 64632 0
+61 431620030
Fax 64632 0
Email 64632 0
rafpellatt@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Clinical study report
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary