A randomised controlled trial of single antibiotic cement versus dual antibiotic cement in patients receiving a partial hip joint replacement after fracture
| ISRCTN | ISRCTN15606075 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15606075 |
| Secondary identifying numbers | 38386 |
- Submission date
- 16/07/2018
- Registration date
- 17/07/2018
- Last edited
- 26/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English Summary
Background and study aims
This study is comparing two types of treatments in patients who have suffered a hip fracture and need to have a partial hip replacement (also called a hemiarthroplasty). The hemiarthroplasty implant is inserted into the thigh bone and replaces the ‘ball’ part of the ‘ball-and-socket’ hip joint. ‘Bone cement’ is used to hold the implant in place. This study aims to compare two different antibiotic bone cement mixtures used to hold the implant in place. The results of this trial should show whether there is any difference in the rate of deep infection in patients when one of the two bone cement mixtures is used to hold their hemiarthroplasty implant in place. The information gained will help patients and their doctors make more informed decisions about the best way to reduce the risk of deep infection in this type of surgery.
Who can participate?
Patients 60 years of age or older who have been admitted to a participating hospital with a hip fracture that the surgeon feels should be treated with a hip hemiarthroplasty
What does the study involve?
Participants are randomly allocated to receive one of two types of bone cement. The first type has a lower dose of a single type of antibiotic, and the second type has a higher dose of that same antibiotic, as well as a second type of antibiotic. Participants complete a questionnaire about their recovery by telephone at 120 days after their surgery.
What are the possible benefits and risks of participating?
There is no specific advantage to patients from taking part in the study. However, the results of this study will help to decide which treatment is best for patients with this type of injury. Any operation for a broken hip carries some risks. The risks of surgery with an implant include: bleeding requiring blood transfusion, infection, further fracture, dislocation, leg length discrepancy, blood clots, damage to nerves and blood vessels in the surgical area, and the risks associated with the anaesthetic. These risks are the same as for patients who are not part of this study. There are also uncommon risks associated with both types of cement. In a small number of cases, patients having a cemented replacement can have a reaction to the bone cement. If this were to occur, the anaesthetist and surgeon would continue treatment as per normal practice. This risk is the same for both types of bone cement.
Where is the study run from?
The study is sponsored by the Northumbria Healthcare NHS Foundation Trust and is managed by Oxford Trauma, a clinical trials research group which is a part of the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS) at the University of Oxford. There will be 20+ hospitals from across the United Kingdom participating in the study.
When is the study starting and how long is it expected to run for?
December 2017 to December 2021
Who is funding the study?
Heraeus Medical GmbH
Who is the main contact?
Stephanie Wallis
white8-copal@ndorms.ox.ac.uk
Contact information
Scientific
Northumbria Healthcare NHS Foundation Trust
Woodhorn Lane
Ashington
NE63 9JJ
United Kingdom
| Phone | +44 (0)1865 223111 |
|---|---|
| White8-copal@ndorms.ox.ac.uk |
Scientific
Northumbria Healthcare NHS Foundation Trust
Woodhorn Lane
Ashington
NE63 9JJ
United Kingdom
Study information
| Study design | Randomised; Interventional; Design type: Treatment, Surgery |
|---|---|
| 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 the contact details to request a patient information sheet |
| Scientific title | WHiTE 8 COPAL: a randomised controlled trial of low dose single antibiotic loaded cement versus high dose dual antibiotic loaded cement in patients receiving a hip hemiarthroplasty after fracture |
| Study acronym | WHiTE 8 COPAL |
| Study hypothesis | This trial aims to establish if a high dose, dual antibiotic regime has fewer infections compared to low dose single antibiotic cement. |
| Ethics approval(s) | Wales REC 5, 03/05/2018, ref: 18/WA/0154 |
| Condition | Hip fracture |
| Intervention | Participants will undergo surgery at the next available opportunity on a planned trauma list. Participants will be blinded to the treatment allocation. The operating surgeon will not be blinded to the allocation. Where possible clinical outcomes will be assessed by blinded assessors. Patients will be kept blinded until the completion of the trial when the blind may be broken. Group 1: Cemented hemiarthroplasty with low dose single antibiotic cement Replacement of the femoral head and neck with choice of femoral head and stem. Cement used will be Heraeus Palacos R+G cement (Hanau, Germany) – contains gentamicin 0.5 grams per 40 gram mix of cement. Group 2: Cemented hemiarthroplasty with high dose dual antibiotic cement Replacement of the femoral head and neck with choice of femoral head and stem. Cement used will be Heraeus Copal G+C cement (Hanau, Germany) – contains gentamicin 1 g and clindamycin 1 g per 40 gram mix of cement. Following fixation all patients will undergo a routine rehabilitation prior to discharge from hospital. Research staff will complete the infection-related questions at baseline, and at 4 months (120 days) post-surgery. In addition the following data will be collected: 1. Demographic and baseline characteristics (e.g. age, gender, pre-fracture mobility) 2. Routine 'operation notes' and 'discharge summaries' that include details of patient's diagnosis and treatment, perioperative complications, and discharge details 3. Medical record review for diagnosis of infection 4. Details of admission, assessment and treatment 5. Details of antibiotics use and microbiological reports for reported infections 6. Contact details, including of carers when appropriate 7. Complications and SAEs during the study period Following their 4-month questionnaire, patients will have completed their participation in the trial and will continue to be treated as per normal standard of care. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Deep Infection of surgical wound; the trialists will use the Centre for Disease Control and Prevention definition of a “deep surgical site infection”, that is a wound infection involving the tissues deep to the skin that occurs within 90 days of injury. Medical records for all patients will be reviewed by appropriately trained staff for indicators of infection at the time of the patient’s discharge from the research site. In addition, at 120 days post-surgery, the patients will self-report (via telephone interview, electronic media or postal questionnaire) on signs of infections. When potential signs of infection have been found, either at discharge or 120 days, the site will be asked to provide, if available, copies of: any re-operation records for surgery related to the index hip fracture, details of antibiotics prescribed, microbiology reports if samples of the suspected infected tissues around the hip were sent for analysis and imaging reports for any deep imaging that occurred in relation to suspected infection. These data will be collated by the central trial team in Oxford. |
| Secondary outcome measures | 1. Mortality recorded at discharge from the research site as well as in the 120-day follow-up. Sites or consultees may also report mortality at any point in the time between discharge and 120 days. 2. Health-related quality of life measured by EuroQol EQ-5D-5L at baseline and at 120 days post-surgery 3. All complications and surgical interventions related to the index wound will be recorded. These are reported by sites as they become aware of events, as well as by patients, carers or consultees at 4 months (120 days) 4. Antibiotic prescription information will be obtained from the patient, consultee or carer at the 4 months (120 days) follow-up. Should the patient be entered into the trial under nominated consultee agreement and this information not be available from a carer, the trial team may contact the patient’s GP for this information 5. Resistance patterns of infections; all infections identified in the primary endpoint will be assessed for antibiotic resistance profiles by the local microbiology team 6. Resource use; cost data will be obtained from national databases or will be estimated in consultation with the hospital finance department. The cost consequences following discharge, including NHS costs and patients' out-of-pocket expenses will be recorded via a short questionnaire, which will be administered at 4 months (120 days) post-surgery. This will be either by patient or consultee 7. Mobility; the ability to walk indoors and outdoors is rated very highly by patients. It has been included in a recommended ‘core outcome set’ for trials assessing interventions in hip fractures, hence it will be recorded using the CRF. It will be captured at baseline and at 4 months (120 days). 8. Residential status; also captured on CRF. The residential status is also part of the core outcome set for hip fractures and NHFD dataset. It will be captured at baseline and at 4 months (120 days) |
| Overall study start date | 15/12/2017 |
| Overall study end date | 31/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | Planned Sample Size: 4920; UK Sample Size: 4920 |
| Total final enrolment | 4936 |
| Participant inclusion criteria | 1. Aged 60 years or older 2. Intracapsular hip fracture, which in the opinion of the treating surgeon requires acute surgical treatment with a cemented hip hemiarthroplasty |
| Participant exclusion criteria | Patients will be excluded if they are allergic to gentamicin or clindamycin |
| Recruitment start date | 01/08/2018 |
| Recruitment end date | 31/08/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
- United States of America
- Wales
Study participating centres
OX3 9DU
United Kingdom
Ground Floor, Victoria Building
Leicester
LE1 5WW
United Kingdom
East Block Level 2
Colney Lane
Norwich
NR4 7UY
United Kingdom
Cornelia House
Longfleet Road
Poole
BH15 2JB
United Kingdom
Lancaster House
Portsmouth
PO6 3LY
United Kingdom
4th Floor
North Block
Institute of Translational Medicine
Hertiage Building
Birmingham
B15 2TH
United Kingdom
Level 2 | North Block
London Road
Reading
RG1 5AN
United Kingdom
Sussex House
1 Abbey Road
Brighton
BN12 1ES
United Kingdom
Level 2, Room 12
Newcastle Upon Tyne
NE1 4LP
United Kingdom
Department of Orthopaedics
Office 6, Gate 18, Level 1
Brunel Building
Bristol
BS10 5NB
United Kingdom
Research & Development
Room ACF40002
4th Floor, West Wing
UHCW, Clifford Bridge Road
Walsgrave
Coventry
CV2 2DX
United Kingdom
Trauma & Orthopaedic Audit Office
C Floor, West Block, QMC (WC1285)
Nottingham University Hospitals
Nottingham
NG7 2UH
United Kingdom
Cardiff & Vale University Health Board
Cardiff & Vale Orthopaedic Centre (CAVOC)
University Hospital Llandough
Penlan Road
Penarth
Cardiff
CF64 2XX
United Kingdom
Orthopaedic Research Room
Fracture Clinic
Lower Lane
Liverpool
L9 7AL
United Kingdom
Salford
M6 8HD
United Kingdom
Morriston
SA6 6NL
United Kingdom
Southmoor Road
Wythenshawe
M23 9LT
United States of America
2nd Flor, Area 5
Whinney Heys Road
Blackpool
FY3 8NR
United Kingdom
Heath Road
Ipswich
IP4 5PD
United Kingdom
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Sandwell Medical Research Unit
Opposite Diabetes Centre
Lyndon
West Bromwich
B71 4HJ
United Kingdom
B16 Knowledge Spa
Royal Cornwall Hospitals NHS Trust
Truro
TR1 3HD
United Kingdom
Woodhorn Lane
Ashington
NE63 9JJ
United Kingdom
2nd Floor, Hambleden Wing
Denmark Hill
London
SE5 9RS
United Kingdom
Banbury
OX16 9AL
United Kingdom
Sponsor information
Hospital/treatment centre
North Tyneside General Hospital
Rake Lane, North Shields
Tyne & Wear
North Shields
NE29 8NH
England
United Kingdom
| Phone | +44 (0)344 811 8111 |
|---|---|
| white8-copal@ndorms.ox.ac.uk | |
| Website | https://www.northumbria.nhs.uk/ |
"ROR" |
https://ror.org/01gfeyd95 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/05/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Protocol will be published after the start of the trial. Planned publication of the results in a high-impact peer reviewed journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 01/02/2021 | 14/04/2021 | Yes | No | |
| Results article | 21/06/2023 | 26/06/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
26/06/2023: Publication reference added.
13/01/2023: Total final enrolment added.
12/01/2023: The intention to publish date was changed from 01/05/2022 to 01/05/2023.
08/11/2021: The following changes were made to the trial record:
1. The overall end date was changed from 15/11/2021 to 31/12/2021.
2. The plain English summary was updated to reflect these changes.
14/04/2021: The following changes have been made:
1. The recruitment end date has been changed from 30/04/2021 to 31/08/2021.
2. Publication reference added.
08/07/2020: The following trial participating centres were added: University Hospital Aintree, Salford Royal Hospital, Morriston Hospital, Wythenshawe Hospital, Blackpool Victoria Hospital, Ipswich Hospital, James Cook University Hospital, Sandwell General Hospital, Royal Cornwall Hospital, Northumbria Specialist Emergency Care Hospital, Kings College Hospital, Horton General Hospital.
04/06/2020: Recruitment has resumed.
23/04/2020: Due to current public health guidance, recruitment for this study has been paused.
22/03/2019: The condition was updated.
18/07/2018: Internal review.
