Quality of life after open fracture of the leg bones
| ISRCTN | ISRCTN31179727 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31179727 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 295778 |
| Protocol serial number | IRAS 295778, CPMS 50253 |
| Sponsor | University of Oxford |
| Funder | AO UK&I |
- Submission date
- 21/05/2022
- Registration date
- 06/07/2022
- Last edited
- 04/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
Open fractures are severe and life-changing injuries. The management of these patients is complex and best accomplished by multidisciplinary teams. It takes a long time for patients to rehabilitate, and many have permanent loss of function. According to the World Health Organisation, trauma remains relatively neglected in developing countries. Researchers have studied the inequalities of access to treatment from a global perspective by assembling an international collaborative network on lower limb reconstruction (INTELLECT), including hospitals in 16 countries ranging from high to low income. They now plan to take advantage of this network to study the impact of open lower extremity (leg) fractures on quality of life as these data have not been previously described in patients from medium and low-income countries.
Who can participate?
Patients admitted with open lower extremity (leg) fractures to participating hospitals
What does the study involve?
Participants complete questionnaires that measure their quality of life while in the hospital to understand their quality of life before and shortly after an open fracture. This is repeated after 3 and 12 months.
What are the possible benefits and risks of participating?
There are no benefits to the patients that wish to participate in the study. A potential risk is that they may find it distressing to complete a quality of life questionnaire after such an injury.
Where is the study run from?
University of Oxford (UK)
When is the study starting and how long is it expected to run for?
June 2020 to March 2024
Who is funding the study?
AO UK&I
Who is the main contact?
Mr Juan Berner
juan.berner@kellogg.ox.ac.uk
Contact information
Scientific
Royal London Hospital
Whitechapel Rd
London
E1 1FR
United Kingdom
| Phone | +44 (0)20 7377 7000 |
|---|---|
| juan.berner@kellogg.ox.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Quality of life after open extremity trauma (QUINTET): a prospective, multi-centre, international study |
| Study acronym | QUINTET |
| Study objectives | There is an impact on quality of life after an open lower limb fracture. |
| Ethics approval(s) | Approved 19/10/2021, East of England - Cambridge South Ethics Committee (Equinox House, City Link, Nottingham, NG2 4LA, UK; +44 (0)207 104 8084, +44 (0)207 104 8104, +44 (0)207 104 8109; cambridgesouth.rec@hra.nhs.uk), ref: 21/EE/0197 |
| Health condition(s) or problem(s) studied | Open lower extremity fractures |
| Intervention | Recruited patients complete questionnaires that measure their quality of life while in the hospital to understand their quality of life before and shortly after an open fracture. This is repeated at 3 and 12 months. |
| Intervention type | Other |
| Primary outcome measure(s) |
Quality of life measured with the 5-Dimension EuroQol (EQ-5D-3L) and Short Form 12 (SF-12) instruments twice during the acute admission. For the first assessment patients will be asked to appraise their quality of life before their injury and for the second assessment their quality of life at present while an inpatient. This assessment will be repeated at 3 months and 12 months post-injury. |
| Key secondary outcome measure(s) |
Clinical outcomes (wound infection, deep infection, non-union, amputation) collected from clinical notes during the period of time that the patient is enrolled in the study (12 months) |
| Completion date | 31/03/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 200 |
| Total final enrolment | 92 |
| Key inclusion criteria | Patients admitted with an open lower limb fracture |
| Key exclusion criteria | Patients unable to consent |
| Date of first enrolment | 01/06/2022 |
| Date of final enrolment | 31/03/2023 |
Locations
Countries of recruitment
- United Kingdom
- England
- Austria
- Chile
- Netherlands
- Spain
- Sudan
Study participating centres
Santiago
00000
Chile
Santa Cruz de Tenerife
38320
Spain
London
W2 1NY
United Kingdom
Tooting
London
SW17 0QT
United Kingdom
Coventry
CV2 2DX
United Kingdom
Newcastle upon Tyne
TS1 4LP
United Kingdom
Hull
HU3 2JZ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | Participant level data will not be made freely available as per the researchers' agreement with the ethics committee that reviewed this study. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/12/2024 | 04/04/2025 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 1.2 | 10/11/2022 | 06/03/2023 | No | No |
Additional files
- ISRCTN31179727_PROTOCOL_V1.2_10Nov22.pdf
- Protocol file
Editorial Notes
04/04/2025: Publication reference and total final enrolment added.
04/04/2024: The overall trial end date has been changed from 31/12/2024 to 31/03/2024.
06/03/2023: The following changes were made to the trial record:
1. Protocol uploaded (not peer reviewed).
2. Amsterdam UMC, Ribat University Hospital, AUVA Traumazentrum, Royal London Hospital, and Derriford Hospital were removed from the trial participating centres.
04/01/2023: The following changes have been made:
1. The recruitment end date has been changed from 31/12/2022 to 31/03/2023.
2. The overall trial end date has been changed from 31/12/2023 to 31/12/2024 and the plain English summary was updated accordingly.
3. The Intention to publish date has been changed from 31/12/2024 to 31/12/2025.
04/08/2022: Internal review.
25/05/2022: Trial's existence confirmed by the East of England - Cambridge South Ethics Committee.
