Segmental tibial fracture fixation - a feasibility study

ISRCTN	ISRCTN11229660
DOI	https://doi.org/10.1186/ISRCTN11229660
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	246299
Protocol serial number	40851; 2018.0277, IRAS 246299
Sponsor	St George's University Hospitals NHS Foundation Trust
Funder	Research for Patient Benefit Programme

Submission date: 02/05/2019
Registration date: 10/05/2019
Last edited: 13/04/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Every year, many people break their legs. In 12%, the tibia (shin bone) fractures into several pieces that sometimes poke out through the skin requiring a difficult operation. There are two main ways to carry out the operation, either putting a metal rod in the bone or a metal frame outside the bone to help it heal. It is not known which operation is better as previous research looking at these treatments has not been done well and has not provided any definite answers. The researchers are planning a study across the NHS to compare treatment with a metal rod to a frame to see which is better. Before doing a large study like this they need to consider how best to run it and if it will work in practice. They need to know if patients and surgeons would be willing to take part, how they feel about the two different operations and how they should measure “success” after the operation. This is called a feasibility study and the aim is to find out whether a larger study is possible and how it should be run.

Who can participate?
Patients aged 16 and over with a tibia (shin) that is fractured in two or more places and that needs to be repaired with either a metal rod or frame.

What does the study involve?
Participants are randomly allocated to be treated with one of the operations below:
A – Intramedullary Nail
In this operation the surgeon inserts a metal rod into the middle of the tibia, from the knee to just above the ankle. There is no metal visible outside the skin. The metal rod stays within the bone after the patient has recovered.
B – Circular Frame External Fixation
In this operation the surgeon builds a metal frame around the leg, which is connected to the bone with pins. The frame stays in place until the bone has healed. It needs to be cleaned and looked after during this time. When the bone is healed there is another operation to remove the frame. After this there is no metal left in the leg.
After the operation, the clinical team looks after study participants with no change to usual care. 3 and 6 months later, the research team in Oxford send participants short questionnaires. These take around 15 minutes to fill out and ask about the patients’ health and recovery since their operation.

What are the possible benefits and risks of participating?
The researchers cannot guarantee a benefit to patients who take part in this study. The results from the study may benefit future patients with similar fractures. Taking part in the study will not change the standard of care participants receive. Both operations are already routinely done in the NHS.

Where is the study run from?
St George’s University Hospitals NHS Foundation Trust is the study sponsor, meaning they are responsible for the study. The Surgical Intervention Trials Unit in Oxford and the Oxford Clinical Trials and Research Unit are supporting the study management.

When is the study starting and how long is it expected to run for?
October 2018 to May 2020

Who is funding the study?
National Institute for Health Research (NIHR), Research for Patient Benefit (RfPB) programme (UK)

Who is the main contact?
Miss Caroline Hing
stiff@ndorms.ox.ac.uk

Contact information

Mrs Molly Glaze
Scientific

Surgical Intervention Trials Unit (SITU)
Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences
University of Oxford
Botnar Research Centre
Windmill Road
Oxford
OX3 7LD
United Kingdom

Phone	+44 (0)1865 223489
Email	stiff@ndorms.ox.ac.uk

Study information

Primary study design	Interventional
Study design	Feasibility study consisting of randomised pilot, patients and staff qualitative study, rehabilitation survey
Secondary study design	Randomised controlled trial
Scientific title	Segmental Tibial Fractures, reamed Intramedullary nailing versus circular Frame external Fixation - a feasibility study
Study acronym	STIFF-F
Study objectives	Every year, many people break their legs. In 12%, the tibia (shin bone) fractures into several pieces that sometimes poke out through the skin requiring a difficult operation. There are two main ways to carry out the operation, either putting a metal rod in the bone or a metal frame outside the bone to help it heal. It is not known which operation is better as previous research looking at these treatments has not been done well and has not provided any definite answers. The researchers are planning a study across the NHS to compare treatment with a metal rod to a frame to see which is better. Before doing a large study like this they need to consider how best to run it and if it will work in practice. They need to know if patients and surgeons would be willing to take part, how they feel about the two different operations and how they should measure “success” after the operation. This is called a feasibility study and will show whether a larger study is possible and how it should be run to give us an answer.
Ethics approval(s)	Approved 30/04/2019, South Central – Berkshire Research Ethics Committee (Bristol REC Centre, Whitefriars, Level 3 Block B, Lewins Mead, Bristol, BS1 2NT; Tel: +44 (0)207 104 8241; Email: nrescommittee.southcentral-berkshire@nhs.net), ref: 19/SC/0073
Health condition(s) or problem(s) studied	Segmental tibial fractures
Intervention	Participants will be assigned to receive an intramedullary nail or a circular frame external fixation. A web-based randomisation system will be used and the allocations will be computer generated with a 1:1 ratio, and stratified by site using random permuted blocks of varying size within stratum.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	The feasibility of a multicentre randomised controlled trial comparing intramedullary nailing (IN) with circular frame external fixation (CFEF), measured through the rates of recruitment and retention in a randomised pilot study over the 21-month study period.
Key secondary outcome measure(s)	1. Conflicts or areas of concern for the research pathway compared with the existing clinical pathway, measured through the identification of all adults with segmental tibial fractures, recording the rationale for eligibility and the reasons why eligible patients do not enter the study. Interviews with patients and staff will explore this further. This will be measured over the 21 month study period 2. Compliance with the randomised allocation, measured by the completion of allocated surgical procedure over the 6-month recruitment period. 3. Standard deviation of the outcome measure Disability Rating Index to estimate the definitive sample size. This will be measured using the Disability Rating Index 6 months after randomisation 4. Feasibility of a definitive economic evaluation of IN versus CFEF, measured using Health Resource Use information 6 months after randomisation 5. Quality of life post-fixation, measured using Pittsburgh Sleep Quality Index, Tampa Scale of Kinesiophobia and EQ-5D-5L 6 months after randomisation 6. Healing rates, measured by radiological images assessed by the RUST score 6 months after randomisation 7. Current post-operative rehabilitation regimes, measured through a rehabilitation survey sent to healthcare professionals, and through interviews with staff and patients to identify current experience of rehabilitation. This will be measured over the 21 month study period 8. The variability of patient experiences of injury, treatment and recovery, such as pain, mobility, emotions and body image, across the two treatment options. This will be measured using interviews with patients to gain a detailed understanding of the impact of both treatments and outcomes important to them. This will be measured over the 21 month study period 9. The views of clinicians and patients on the factors that facilitate or inhibit trial recruitment, measured using interviews with staff and patients/consultee to identify the feasibility of undertaking a full trial. This will be measured over the 21-month study period
Completion date	04/05/2020

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	16 Years
Sex	All
Target sample size at registration	50
Total final enrolment	3
Key inclusion criteria	Adults (16 years and over) with a segmental tibial fracture (open or closed) deemed suitable for either an intramedullary nail or an external fixation
Key exclusion criteria	1. Patients under 16 2. Prior failed fixation 3. Pathological fracture 4. Infection present 5. Pre-existing (pre-injury) skin condition which precludes open surgery 6. Patient is/would be unable to understand instructions for treatment* 7. Patient is unable to complete the follow-up requirements 8. More than 21 days since injury
Date of first enrolment	13/05/2019
Date of final enrolment	06/02/2020

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

St George's Hospital

Blackshaw Road
London
SQ17 0QT
United Kingdom

St Mary's Hospital

Praed Street
London
W2 1NY
United Kingdom

Hull Royal Infirmary

Anlaby Road
Hull
HU3 2JZ
United Kingdom

Royal Liverpool University Hospital

Prescot Stree
Liverpool
L7 8XP
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		10/04/2021	13/04/2021	Yes	No
HRA research summary			28/06/2023	No	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

13/04/2021: Publication reference added.
21/02/2020: The following changes have been made:
1. The recruitment end date has been changed from 12/11/2019 to 06/02/2020.
2. The overall trial end date has been changed from 30/06/2020 to 04/05/2020 and the plain English summary has been updated to reflect this change.
3. The intention to publish date has been changed from 01/07/2021 to 04/05/2021.
4. The total final enrolment number has been added.
5. The IRAS number has been added.
03/05/2019: Trial's existence confirmed by the NIHR.