INFORM - surgery for hip infection project
| ISRCTN | ISRCTN10956306 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10956306 |
| Secondary identifying numbers | 18159 |
- Submission date
- 28/01/2015
- Registration date
- 29/01/2015
- Last edited
- 13/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English Summary
Background and study aims
Hip replacement surgery is common, with over 86,000 cases in England and Wales in 2012. After surgery about 1% patients develop a deep infection in their artificial hip, called a prosthetic joint infection (PJI). If left untreated PJI can result in severe pain, disability and death. When an infection is found, there are two types of surgical treatment: a 1-stage revision involves removing the joint, thoroughly cleaning the infected area and implanting a new joint immediately; a 2-stage revision involves removing the joint, and delaying re-implantation for 3 to 6 months whilst treating with antibiotics. Both treatments are widely used but we don’t know which has the best long-term outcomes for patients. The aim of this study is to find out whether there is any difference in patient-reported outcomes (pain, stiffness or physical function) after 1-stage or 2-stage revision hip surgery for PJI.
Who can participate?
Patients that have a prosthetic joint infection that needs surgery.
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 have 1-stage revision surgery. Those in group 2 have 2-stage revision surgery. All participants are then followed up for the next 18 months. They are asked to complete questionnaires every 3 months, to assess their hip pain and function, quality of life and any costs incurred during their treatment. They attend two appointments with a research nurse to complete questionnaires and a walk test. A small number of participants and surgeons are also interviewed about their experiences of treatment and participation in the trial. Participants who decide against the randomised trial are asked to join a monitoring group. This group have treatment-as-usual, and then complete questionnaires at home. The monitoring group provide important information on the wider population of patients with hip PJI, including patient reported outcomes, control of infection and adverse events.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
14 hospitals in the UK and 3 in Sweden (UK)
When is the study starting and how long is it expected to run for?
January 2015 to February 2020
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Mr Simon Strange
Contact information
Scientific
INFORM Programme Manager
Musculoskeletal Research Unit
Level 1, Learning and Research
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
| Phone | +44 (0)7789777053 |
|---|---|
| simon.strange1@nhs.net |
Study information
| Study design | Randomised; Interventional and Observational; Design type: Not specified, Treatment, Qualitative |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a patient information sheet |
| Scientific title | A multicentre randomised trial to compare 1-stage with 2-stage revision surgery for prosthetic hip joint infection |
| Study hypothesis | The aim of this study is to determine if there is any difference in patient-reported outcomes (pain, stiffness or physical function) after 1-stage or 2-stage revision hip surgery for prosthetic joint infection (PJI). |
| Ethics approval(s) | NRES Committee South-West - Frenchay, 31/12/2014, ref: 14/SW/1166 |
| Condition | Topic: Surgery; Subtopic: Surgery; Disease: All Surgery |
| Intervention | Revision hip surgery 1-stage or 2-stage revision for infected prosthetic hip joint; Follow Up Length: 18 month(s) |
| Intervention type | Other |
| Primary outcome measure | Patient-reported hip pain, stiffness, function; Timepoint(s): WOMAC at 18 months post-randomisation |
| Secondary outcome measures | 1. Quality of life, measured using Euroquol EQ-5D-5L and HOOS 2. All hip-related complications (including continuing and reinfection) recorded throughout study period 3. Post-op pain, measured using the Brief Pain Inventory 4. Patient-reported hip function, measured using the Oxford Hip Score 5. Objective measure of hip function, measured using the 20 metre timed walk test 6. Depression and anxiety, measured using the Hospital Anxiety and Depression Score 7. Cost-effectiveness of interventions, measured using health resource use |
| Overall study start date | 10/02/2014 |
| Overall study end date | 28/02/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 228; UK Sample Size: 228; Description: RCT - 142 patients; Monitoring group - approx 80 participants |
| Total final enrolment | 177 |
| Participant inclusion criteria | 1. Age 18 or above 2. A clinical diagnosis of prosthetic hip joint infection 3. Require revision surgery (either 1-stage or 2-stage) to treat prosthetic hip joint infection, in the opinion of the treating consultant orthopaedic surgeon Target Gender: Male & Female ; Lower Age Limit 18 years |
| Participant exclusion criteria | 1. Unable or unwilling to undergo either 1-stage or 2-stage revision surgery 2. Lack capacity to give written informed consent |
| Recruitment start date | 04/03/2015 |
| Recruitment end date | 31/08/2018 |
Locations
Countries of recruitment
- England
- Sweden
- United Kingdom
Study participating centre
Beckspool Road
Frenchay
Bristol
B16 1JE
United Kingdom
Sponsor information
Hospital/treatment centre
Research & Innovation
Floor 3 Learning & Research Building
Southmead Hospital
Bristol
BS10 5NB
England
United Kingdom
"ROR" |
https://ror.org/036x6gt55 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/09/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | 1. Protocol paper 2. Trial results paper 3. Cost-effectiveness analysis paper 4. Dissemination of Best Practice Guidance |
| IPD sharing plan | Participant level data will be made available at the data.bris (University of Bristol Research Data repository) beginning 1 year following publication of the trial results. Access to data will ‘controlled’ and request forms can be found at http://www.bristol.ac.uk/staff/researchers/data/accessing-research-data/ |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 17/02/2016 | Yes | No | |
| Results article | 31/10/2022 | 01/11/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | What are patients’ preferences for revision surgery after periprosthetic joint infection? A discrete choice experiment | 21/01/2020 | 13/02/2024 | Yes | No |
| Other publications | qualitative study | 03/08/2020 | 13/02/2024 | Yes | No |
| Results article | 01/11/2022 | 13/02/2024 | Yes | No |
Editorial Notes
13/02/2024: Publication references added.
01/11/2022: Publication reference added.
06/04/2022: The intention to publish date has been changed from 31/12/2021 to 01/09/2022.
07/09/2021: The following changes have been made:
1. The intention to publish date has been changed from 30/06/2021 to 31/12/2021.
2. The trial contact has been updated.
06/04/2021: The following changes were made to the trial record:
1. The recruitment start date was changed from 19/01/2015 to 04/03/2015.
2. The intention to publish date was changed from 01/02/2021 to 30/06/2021.
17/11/2020: The intention to publish date was changed from 09/05/2020 to 01/02/2021.
18/03/2020: The total final enrolment was added.
27/09/2018: IPD sharing statement added.
23/07/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/05/2018 to 31/08/2018.
2. The overall trial end date was changed from 30/11/2019 to 28/02/2020.
3. The intention to publish date was changed from 09/02/2020 to 09/05/2020.
4. Sweden was added to the countries of recruitment.
5. The RCT recruitment target was changed from 148 to 142.
06/07/2017: The following changes were made to the trial record:
1. The overall trial start date was changed from 19/01/2015 to 10/02/2014.
2. The overall trial end date was changed from 19/01/2017 to 30/11/2019.
3. The recruitment end date was changed from 19/01/2017 to 31/05/2018.
4. The intention to publish date was changed from 01/12/2018 to 09/02/2020.
18/02/2016: Publication reference added.
