Condition category
Musculoskeletal Diseases
Date applied
14/07/2020
Date assigned
14/07/2020
Last edited
07/08/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Metacarpal shaft fractures are breaks (also known as fractures) in the middle part of the bones in the hand. They are very common injuries in young, working-age people. At the moment, we do not know how best to treat them, so patients get different care in different parts of the country.
The best way of finding out is to do a trial comparing treatments. This study will assess whether a future trial is possible and how best to carry it out, to tell us the most effective way of treating these injuries.

Who can participate?
Adults (16 years and over) who have had a break in the middle part of the index to little finger metacarpal.

What does the study involve?
Participants will be asked to attend one clinic visit in addition to their routine clinical care and to complete some questionnaires remotely. If participants are willing to talk to us about their injury and taking part in research, we may invite participants for an interview and/or focus group.
The questionnaires are short and easy to complete and all reasonable expenses, such as travel and parking costs associated with attending the research clinic, patient interviews and focus groups will be fully reimbursed.

What are the possible benefits and risks of participating?
The information we get from this study will help us to improve treatment for other people like participants in the future.
Taking part in this study does not affect the usual care participants receive. We will just be monitoring how participants and their hand are recovering, so there are no risks to taking part in this study.

Where is the study run from?
This research is being organised by the University of Nottingham and will be recruiting patients from hand fracture clinics at Queen’s Medical Centre, Nottingham and the Pulvertaft Hand Centre, Derby.

When is the study starting and how long is it expected to run for?
June 2020 to January 2022

Who is funding the study?
This study is funded by the National Institute for Health Research (NIHR).

Who is the main contact?
Miss Rowa Taha, FACTS-Study@nottingham.ac.uk

Trial website

https://www.nottingham.ac.uk/research/groups/cebhs/projects/hand-wrist-fractures/facts-study.aspx

Contact information

Type

Public

Primary contact

Miss Rowa Taha

ORCID ID

http://orcid.org/0000-0002-2403-5107

Contact details

Centre for Evidence Based Hand Surgery
University of Nottingham
Queen's Medical Centre Campus
C Floor
West Block
Derby Road
Nottingham
NG7 2UH
Nottingham
NG7 2UH
United Kingdom
+44 (0) 115 823 1113
FACTS-study@nottingham.ac.uk

Type

Scientific

Additional contact

Miss Rowa Taha

ORCID ID

http://orcid.org/0000-0002-2403-5107

Contact details

Centre for Evidence Based Hand Surgery
University of Nottingham
Queen's Medical Centre Campus
C Floor
West Block
Derby Road
Nottingham
NG7 2UH
Nottingham
NG7 2UH
United Kingdom
+44 (0) 115 823 1113
FACTS-study@nottingham.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS 279115

Study information

Scientific title

Fractures of Adult metaCarpal shafTS (FACTS): Surgical and non-surgical treatment for metacarpal shaft fractures in adults: an observational feasibility study

Acronym

FACTS

Study hypothesis

1. To investigate the feasibility and acceptability of conducting a pragmatic multi-centre randomised controlled trial (RCT) to assess the clinical and cost-effectiveness of surgical versus non-surgical treatment for metacarpal shaft fractures in adults.
2. To provide complementary, detailed and person-centred insight that will inform RCT design through the identification of barriers to participation amongst patients with metacarpal shaft fractures and to develop novel solutions to engage these cohorts in research.

Ethics approval

Approved 12/06/2020, Cambridge South Research Ethics Committee (The Old Chapel Royal Standard Place Nottingham NG1 6FS, UK; no telephone number provided; cambridgesouth.rec@hra.nhs.uk), ref: 20/EE/0124

Study design

Dual-centre prospective cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Metacarpal shaft fractures of the finger digits in adults

Intervention

This is an observational study. Patients treated in the two participating centres will be recruited to the study. No additional interventions outside of routine care will be undertaken. The outcomes of interest include feasibility outcomes relating to; assessment of eligibility, recruitment and retention rates; completion of follow-up; evaluation of outcome measures and calculation of the minimal clinically important difference (MCID) for the primary outcome measures using quantitative and qualitative assessments and establishing the feasibility of data collection methods and appropriate time-points for use in a future trial.

A nested qualitative study consisting of two elements, patient interviews and focus groups, will be conducted to provide patient-centered insight into study procedures and explore the individual impact of the injury. Patients will be selected from the prospective cohort study and further written informed consent separately sought.

An economic evaluation to estimate costs of treatments for metacarpal shaft fractures through representative micro-costing will be undertaken. Resource use directly linked to the metacarpal shaft fractures and its sequela and/or complications over the 6 months of follow-up will be recorded for each participant.

A two by two by two factorial design randomised sub-study will be nested within the main cohort study. Once participants have consented to the cohort study or qualitative study, they will be randomised to a sub-study that will evaluate the use of text messages to maximise data collection and participant retention in the study. The interventions will be: frequency of SMS messages – participants will receive either fortnightly or monthly messages; two-way communication - text message requiring a response from the participant versus a notification message only; and personalisation - personalised text message versus a standard automated message.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Feasibility outcomes are:
1. Number and proportion of patients assessed for eligibility
2. Size of the eligible patient pool available for recruitment
3. Identification of primary outcome measures for use in a future RCT
4. Estimation of the minimal clinically important difference (MCID) for selected outcome measures
5. Completion of follow-up assessments
6. Evaluation of the use of text messages in optimising data collection and retention

Secondary outcome measures

1. Hand function at 6 weeks by measuring the range of motion and grip strength
2. Xrays taken as part of routine clinical care will be reviewed at the 6-week research clinic and the location, type of fracture, amount of shortening, angulation and presence of step-off deformity on the X-rays will be recorded.
3. Questionnaires, patient-reported outcome measures, consisting of the hand health profile of the Patient Evaluation Measure (PEM), Patient-Reported Outcomes Measurement Information System Upper Extremity (PROMIS-UE), Shortened Disabilities of the Arm, Shoulder and Hand Outcome Measure (QuickDASH), European quality of life questionnaire (EQ-5D-5L) and the Global Rating of Change (GROC) scale will be collected at baseline, 6 weeks, 3 months and 6 months

Overall trial start date

12/06/2020

Overall trial end date

01/01/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Adults 16 years or older
2. Radiologically confirmed metacarpal shaft fracture
3. Acute metacarpal shaft fracture affecting the index to little finger(s), presenting within 10 days of injury
4. Willing and able to give informed consent
5. Ability to understand English

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

84

Participant exclusion criteria

1. Fracture(s) of the thumb
2. Fractures extending into the joint surface
3. Fracture(s) of the metaphyseal base and/or neck of the metacarpal
4. Fracture(s) associated with dislocation at the carpometacarpal joint or other adjacent joint dislocation
5. Open fractures
6. Undisplaced fractures, defined as those with a visible fracture line on radiographs but anatomical alignment, i.e. the bone fragments remain aligned with no evidence of movement of the fracture fragments on anteroposterior, lateral or oblique radiographs
7. Patients who would not be able to adhere to study procedures or complete the study questionnaires

Recruitment start date

01/08/2020

Recruitment end date

01/04/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queen's Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom

Trial participating centre

Pulvertaft Hand Centre
Royal Derby Hospital Kings Treatment Centre (KTC) Level 2 Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Sponsor information

Organisation

University of Nottingham

Sponsor details

Research and Innovation
East Atrium
Jubilee Conference Centre
Triumph Road
Nottingham
NG8 1DH
United Kingdom
+44 (0) 115 84 67105
sponsor@nottingham.ac.uk

Sponsor type

University/education

Website

http://www.nottingham.ac.uk

Funders

Funder type

Not defined

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Results of this study will be reported fully and made publicly available when the research has been completed. The outcomes of the study will be prepared as a research paper for publication in suitable peer-reviewed journals. Reporting will be in compliance with Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines. In order to fulfil reporting guidelines, a copy of the research paper will also be sent to the National Institute for Health Research (NIHR) programme issuing the funding contract.

The findings will be presented at national and international meetings of relevant scientific societies, such as the British Society for Surgery of the Hand Scientific Meeting, Federation of European Societies for Surgery of the Hand Meeting and the International Federation of Societies for Surgery of the Hand Meeting. We will also publish key findings on the Centre for Evidence Based Hand Surgery (CEBHS) website, and via the “Hand Evidence Updates”, distributed by the CEBHS to over 800 national and international members.

Feedback from the Metacarpal Shaft Fracture Patient Advisory Group will guide distribution of findings to the public. This will include but not be limited to; newsletters, local media outlets, events and plain English summaries of all published journal articles. Social media platforms will also be used to maximise dissemination of key findings.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.

Intention to publish date

01/01/2023

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

07/08/2020: Uploaded protocol (not peer reviewed) Version 1.0 07 April 2020. 14/07/2020: Trial’s existence confirmed by Cambridge South Research Ethics Committee.