Condition category
Musculoskeletal Diseases
Date applied
17/01/2020
Date assigned
20/01/2020
Last edited
20/01/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
This study investigates the treatment of a common type of bone break in the section of the finger closest to the knuckle. This injury is called a proximal phalanx shaft finger (PPS) fracture. PPS fractures result from falls, twisting forces or blows to the hand. They are treated in hospital by hand specialists which involves multiple visits to hospital and recovery takes several weeks to months, during which use of the hand is restricted. The aims of treatment are bone healing in good position, prevention of stiffness and return to full function. Although many people heal well, some fractures cause permanent pain, finger stiffness or deformity, which limit use of the hand and affect the way the finger looks. Serious problems need further treatment, including complex surgery. AIM PPS fractures can be treated with or without surgery and we don't know which is best. Current treatment is based on what each specialist believes works best and can vary. NHS hand specialists, patients with PPS fractures and researchers worked together to plan this study, so that a fair and useful comparison of treatments can be made. We will compare two treatments: surgery using metalwork (pins, screws or plates) to fix the fracture versus treatment using finger splints applied in clinic, but sometimes requiring local anaesthetic to improve the fracture position. The aim is to improve care by finding out which treatment is better for the patient; also which represents best value for money.

Patients and the public were involved in prioritizing the research question via the James Lind Alliance Priority Setting Partnership on Common Conditions of the Hand and Wrist. Patients with PPS fractures were actively involved in the study design via a national workshop with clinicians and researchers and two patient focus groups. We established a patient representative group to support our patient co-applicant, who has experienced a PPS fracture treated in the NHS. Two patient representatives will also help oversee the study.

Who can participate?
Adult patients with one or more proximal phalanx shaft finger fracture(s) suitable for surgical or non-surgical splint treatment.

What does the study involve?
Participants will be approached and recruited in secondary care fracture clinics. After giving informed consent to participate in the trial, participants will be randomly assigned to either receive surgery or non-surgical splint treatment. Any other treatment decisions (such as the type of surgery or splint, when to move the finger or take x-rays) will be made by the specialists and the patient, as is done in usual care outside the study.

Participants will be asked to complete questionnaires about how well they can use their hand and their general health (online or by post) at 6 weeks, 6 months and 12 months after joining the study. The primary outcome for the study will be a comparison of a patient completed questionnaire - Patient Evaluation Measure (PEM) at 6 months, compared to the start of the study.

Participants will also be asked to attend a trial clinic visit at 3 months where data will be collected and tests on hand function will be performed (range of motion, grip and pinch strength).

What are the possible benefits and risks of participating?
Possible benefits: You will receive the same level of care from your doctors, whether you choose to participate in the study or not. You may not benefit personally from taking part in this study, but because of the contact with the research team, you will have more regular or frequent opportunity to discuss your PPS finger fracture.

By taking part in this study you will also help to improve the treatment of future patients presenting with a PPS finger fracture. This means that people with such a fracture may in future experience a quicker or more convenient recovery, have fewer complications and better long-term use of their hand. The results of the study will also help plan effective services offered by the NHS.

Possible risks: Both treatments are a part of standard NHS care, so there is no extra risk involved in receiving them as part of the study. We do not know which of these treatments is best for patients with PPS finger fractures which is why we are doing this study. Taking part will mean spending some time to complete questionnaires and one extra visit to the hand clinic at hospital, three months after your first appointment.

Where is the study run from?
Nottingham Clinical Trials Unit, University of Nottingham (UK) and 13 Acute Care NHS Trusts (UK).

When is the study starting and how long is it expected to run for?
September 2019 to August 2023

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Ms Jennifer White, point@nottingham.ac.uk

Trial website

https://www.nottingham.ac.uk/nctu/trials/musculoskeletal.aspx

Contact information

Type

Public

Primary contact

Ms Jennifer White

ORCID ID

Contact details

Nottingham Clinical Trials Unit
University of Nottingham
Room A17
Building 42
University Park
Nottingham
NG7 2RD
United Kingdom
+44 0115 8231586
jennifer.white@nottingham.ac.uk

Type

Scientific

Additional contact

Dr Alexia Karantana

ORCID ID

http://orcid.org/0000-0003-3742-5646

Contact details

Academic Orthopaedics
Trauma and Sports Medicine
Room WC1378
C Floor
West Block
Queen's Medical Centre
Nottingham
NG7 2UH
United Kingdom
+44 0115 8231115
alexia.karantana@nottingham.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS 277440

Study information

Scientific title

Surgery versus non-surgical splint treatment for proximal phalanx shaft fractures

Acronym

POINT

Study hypothesis

To determine the clinical and cost-effectiveness of surgery compared to non-surgical splint treatment for Proximal Phalanx Shaft (PPS) finger fractures in adults

Ethics approval

Pending as of 17/01/2020

Study design

Pragmatic, multi-center, parallel, two-arm, superiority randomized trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Proximal phalanx shaft finger fractures

Intervention

Patients with a PPS fracture coming to hospital will be invited to take part in the study. Patients will then be treated in one of two groups: treatment with surgery OR non-surgical treatment using a finger splint. Each participant will have an equal chance of being in either group; neither the participant nor the specialist will be able to choose, this will be decided randomly by a computer. Any other treatment decisions (such as the type of surgery or splint, when to move the finger or take x-rays) will be made by the specialists and the patient, as is done in usual care outside the study.
Participants will be asked to complete online or postal questionnaires at the start of the study, and at 6 weeks, 6 months and 12 months after joining the study.
Participants will also be asked to attend a trial clinic visit at 3 months where data will be collected and tests on hand function will be performed (range of motion, grip and pinch strength).

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

Participant-reported assessment of hand function measured using the Hand Health Profile of the Patient Evaluation Measure (PEM) questionnaire at 6 months post-randomization

Secondary outcome measures

1. Participant reported assessment of hand function and appearance, using the Hand Health Profile of the PEM questionnaire at 6 weeks, 3 months, and 12 months.
2. Participant-reported assessment of location-specific health (the hand) using the Single Assessment Numeric Evaluation (SANE) tool at 6 weeks, 3 months, 6 months and 12 months.
3. Participant-reported quality of life assessment, using the EQ-5D-5L questionnaire, at 6 weeks, 3 months, 6 months and 12 months.
4. Participant-reported assessment of upper extremity function, using the Patient-Reported Outcomes Measurement Information System (PROMIS) computerised adaptive test, at 6 weeks, 3 months, 6 months and 12 months.
5. Participant-rated appearance of the hand as per item 10 of the Hand Health Profile of the PEM.
6. Investigator assessed active range of motion of affected digit(s), using a finger goniometer at 3 months.
7. Investigator assessed palmar grip and pinch strength of the affected hand, using a hydraulic dynamometer and pinch meter at 3 months.
8. Resource use and costs, assessed by a health economic analysis of health & social services costs (primary analysis) and effects on families and society (secondary analysis).
9. Participant and investigator reported complications, including need for further surgery, recorded in the Case Report Form and participant questionnaire responses.

Overall trial start date

01/09/2019

Overall trial end date

01/08/2023

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients with one or more proximal phalanx shaft finger fracture(s)
2. Age ≥16 years
3. Fracture(s) suitable for either surgery or non-surgical splint treatment as assessed by the investigator
4. Willing and able to give fully informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

1. Fracture(s) occurring ≥14 days before the anticipated time of treatment
2. Open fracture(s)
3. Basal metaphyseal fracture(s)
4. Phalangeal neck fracture(s)
5. Fracture patterns that extend into the joint surface
6. Inability to adhere to trial procedures or complete the study questionnaires

Recruitment start date

01/04/2020

Recruitment end date

01/03/2022

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Nottingham Clinical Trials Unit
University of Nottingham Room A17 Building 42 University Park
Nottingham
NG7 2RD
United Kingdom

Trial participating centre

Gloucestershire Hospitals NHS Foundation Trust
Alexandra House
Cheltenham
GL53 7AN
United Kingdom

Trial participating centre

Sheffield Teaching Hospitals NHS Foundation Trust
Northern General Hospital Herries Road
Sheffield
S5 7AU
United Kingdom

Trial participating centre

Guy's and St Thomas' NHS Foundation Trust
Trust Offices Guy's Hospital Great Maze Pond
London
SE1 9RT
United Kingdom

Trial participating centre

The Rotherham NHS Foundation Trust
Moorgate Road
Rotherham
S60 2UD
United Kingdom

Trial participating centre

Royal Berkshire NHS Foundation Trust
Royal Berkshire Hospital London Road
Reading
RG1 5AN
United Kingdom

Trial participating centre

University Hospitals Of Derby And Burton NHS Foundation Trust
Royal Derby Hospital Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Trial participating centre

Royal United Hospitals Bath NHS Foundation Trust
Combe Park
Bath
BA1 3NG
United Kingdom

Trial participating centre

South Tyneside NHS Foundation Trust
South Tyneside District Hospital Harton Lane
South Shields
NE34 0PL
United Kingdom

Trial participating centre

St George’s University Hospitals NHS Foundation Trust
St George's Hospital Blackshaw Road Tooting
London
SW17 0QT
United Kingdom

Trial participating centre

Buckinghamshire Healthcare NHS Trust
Amersham Hospital Whielden Street
Amersham
HP7 0JD
United Kingdom

Trial participating centre

University Hospitals Coventry And Warwickshire NHS Trust
Walsgrave General Hospital Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Trial participating centre

Chelsea And Westminster Hospital NHS Foundation Trust
Chelsea & Westminster Hospital 369 Fulham Road
London
SW10 9NH
United Kingdom

Trial participating centre

Cardiff & Vale University Local Health Board
Heath Park
Cardiff
CF14 4XW
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
01158467906
sponsor@nottingham.ac.uk

Sponsor type

University/education

Website

https://www.nottingham.ac.uk/fabs/research-innovation/home.aspx

Funders

Funder type

Government

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

Research findings will be disseminated via a HTA monograph in the NIHR Journals library, scientific papers, conference presentations, and communicated to groups involved in guideline development and commissioning decisions.
Trial publications and conference presentations will be submitted to the NIHR HTA for approval prior to submission to the event organisers or the editors. All publications will acknowledge the support of the HTA in funding this trial. All participants will receive a copy of the trial results (unless they have stated they do not wish to receive this). Neutral or negative results will not constitute a reasonable justification to delay publication.

IPD sharing statement:
The data-sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

01/12/2024

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

17/01/2020: Trial’s existence confirmed by the National Institute for Health Research.