Knee replacement bandaging study (KReBS)
| ISRCTN | ISRCTN87127065 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87127065 |
| Secondary identifying numbers | 32352 |
- Submission date
- 20/02/2017
- Registration date
- 20/02/2017
- Last edited
- 31/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
Total knee replacement (TKR) surgery is a common procedure where the weight bearing surfaces of the knee joint are replaced with metal and plastic components to relieve pain and disability. The most common condition which leads to the need for a TKR is osteoarthritis (a type of arthritis where the surface of joints wears away, causing pain and stiffness). Swelling around the knee is commonly seen after a patient has had TKR surgery, and is thought to contribute to pain after surgery and slowing down the rehabilitation process. Inelastic compression bandages (tight-fitting bandages) are routinely used in the treatment of a range of conditions, including leg ulcers and lymphedema (a long-term condition that causes swelling in the body's tissues). Their use in helping reduce swelling is not well documented but it is thought that they aid venous blood return to the heart whilst improving the efficacy of the calf muscles which work as pumps to help return blood and thus help swelling. The aim of this study is to investigate whether use of short stretch inelastic compression bandages can help to reduce pain and swelling after TKR surgery. Blood loss during and following total knee replacement reduces a patient's haemoglobin and haematocrit counts whilst also increasing the need for a transfusion. By controlling the bleeding and subsequent swelling it is also thought that pain after surgery can be reduced. The study also assesses whether the use of a compression bandage will help reduce blood loss.
Who can participate?
Adults who are having a total knee replacement at a participating hospital
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive standard care. This involves application of a cotton wool bandage and crepe following knee replacement. Those in the second group have a compression bandage applied from the foot up to the groin. In both groups, the bandages will be applied in theatre and left in place for up to 48 hours before they are discharged from hospital. At the start of the study and then again after six and twelve months, participants complete a range of questionnaires and assessment to find out how well their knee has recovered after surgery. Participants in Northumbria NHS Foundation Trust also have their routinely taken full blood counts and blood transfusion data collected, and acute pain is assessed through pain scores routinely taken before and after surgery along with their analgesic (painkiller) requirements.
What are the possible benefits and risks of participating?
Participants who receive the compression bandages could benefit from decreased swelling and pain after surgery and ultimately better knee function and outcome. There are no notable risks involved with participating.
Where is the study run from?
Northumbria Healthcare NHS Foundation Trust and 14 other NHS trusts throughout the UK (UK)
When is the study starting and how long is it expected to run for?
August 2016 to November 2020
Who is funding the study?
3M Company (USA)
Who is the main contact?
Mrs Elizabeth Cook
liz.cook@york.ac.uk
Contact information
Public
University of York
Heslington
York
YO10 5DD
United Kingdom
| Phone | +44 (0)1904 321522 |
|---|---|
| liz.cook@york.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment, Device |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN87127065_PIS_05Jan17_V1.doc |
| Scientific title | A randomised controlled trial of the effect of a two-layer compression bandage system on knee function following total knee arthroplasty |
| Study acronym | KReBS |
| Study hypothesis | The aim of this study is to assess the effectiveness and cost-effectiveness of a two-layer compression bandage worn post-operatively for up to 48 hours, compared to standard practice (non-compressive bandaging) on patient reported outcomes following elective total knee replacement. Substudy added 22/02/2018: A substudy is being undertaken as part of a student project that will be reported separately to the main trial. In this substudy it is hypothesised that the use of a compression bandage will act as a tamponade and help reduce blood loss. |
| Ethics approval(s) | North East - Newcastle & North Tyneside 2 Research Ethics Committee, 08/02/2017, ref: 16/NE/0400 |
| Condition | Specialty: Musculoskeletal disorders, Primary sub-specialty: Elective Orthopaedic Surgery; UKCRC code/ Disease: Musculoskeletal/ Other joint disorders |
| Intervention | Participants are randomised to one of two groups via a secure internet system utilising a simple randomisation process. Control group: Participants receive crepe bandage and synthetic wool layer for up to 48 hours post TKR proximal shin to distal thigh following adhesive dressing application in theatre. Intervention group: Participants receive a 2 layer Compression bandage (Coban 2 3M) for 48hrs post TKR from foot to groin following adhesive dressing application in theatre. Standard post knee replacement surgery care for both arms following bandage application. Both arms will have standard hospital led follow up. In addition, Oxford knee score and EQ 5D questionnaires will be sent to patients at six and 12 months respectively as well as SMS text messages for VAS at 10 days, 4 weeks and 12 months post TKR. Substudy added 22/02/2018: Following recruitment into the main study, those patients undergoing total knee replacement in Northumbria NHS Foundation Trust will also have their routinely taken pre and post-operative full blood counts and transfusion data reviewed. Acute pain will also be assessed through routinely taken pre and post-op pain scores and analgesic requirements. |
| Intervention type | Other |
| Primary outcome measure | Patient reported knee function and pain is measured using the Oxford Knee Score at baseline (pre-operatively), 12 months post-operatively Substudy added 22/02/2018: Haemoglobin drop: difference between pre-op at pre-assessment or anaemia clinic and day 1 post-op levels |
| Secondary outcome measures | 1. Patient reported knee function and pain is measured using the Oxford Knee score at baseline (pre-operatively) and 6 months posy-operatively 2. Health related quality of life is measured using the EQ-5D-3L at baseline (pre-operatively), 6 and 12 months post-operatively. 3. Health related quality of life is measured using the EQ-5D-5L at baseline (pre-operatively) and 12 months post-operatively- the validity and responsiveness of EQ5D-5L will be compared against EQ5D-3L. The UK value sets for the EQ-5D-5L are currently being derived and analysis will follow the most recent EuroQol guidance. 4. Pain is measured by VAS at 10 days post-operatively, 4 weeks and 12 months post-operatively 5. Proportion of each patient group that have to return to theatre within 30 days of surgery for any reason is assessed by hospital episode statistics at 12 months post-operatively 6. Proportion of each patient group that is readmitted to hospital within 30 days of surgery for any reason is assessed using local NHS trust patient administration system (PAS) data at 12 months post-operatively 7. Proportion of each patient group that suffers a pulmonary embolism requiring in patient hospitalization within 30 days post-operatively is assessed using local NHS trust patient administration system (PAS) data at 12 months post-operatively 8. Proportion of each patient group that suffers a deep vein thrombosis requiring inpatient hospitalization within 30 days of surgery is assessed using local NHS trust patient administration system (PAS) data at 12 months post-operatively 9. Length of hospital stay will be calculated and assessed by using admission and discharge dates Substudy added 22/02/2018: 1. Haematocrit drop: difference between pre-op at pre-assessment or anaemia clinic and day 1 post-op levels 2. Transfusion rate: units of Red blood cell transfusion as inpatient 3. Length of stay: nights spent as inpatient during acute stay 4. Analgesic requirements: cumulative dose for analgesia whilst an inpatient from patient records 5. Pain score: day 1 post op pain using 1-10 pain scale as recorded by nursing staff and day 10 pain scores via SMS and a pain scale 1-10 |
| Overall study start date | 01/08/2016 |
| Overall study end date | 07/11/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 2600; UK Sample Size: 2600 |
| Total final enrolment | 2338 |
| Participant inclusion criteria | 1. Patients scheduled for primary total knee arthroplasty 2. Presenting at a participating trial site 3. Aged over 18 4. Able to provide written informed consent |
| Participant exclusion criteria | 1. Unable to consent 2. History of peripheral vascular disease 3. History of peripheral neuropathy 4. History of, or current venous ulceration 5. Absent foot pulses 6. Planned same day discharge joint replacement patients 7. Revision knee arthroplasty 8. Unicondylar or patellofemoral joint knee arthroplasty 9. Regular concomitant high dose anti-coagulant medication. Patients on routine thromboprophylaxis can be included 10. Unwilling to provide informed consent 11. Lack mental capacity and therefore unlikely to comply with data collection |
| Recruitment start date | 01/03/2017 |
| Recruitment end date | 31/08/2018 |
Locations
Countries of recruitment
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Sponsor information
Hospital/treatment centre
Wansbeck Hospital
Woodhorn Lane
Ashington
NE68 6JJ
England
United Kingdom
| Phone | +44 (0)344 811 8111 |
|---|---|
| contactus@northumbria.nhs.uk | |
| Website | https://www.northumbria.nhs.uk/our-locations/wansbeck-general-hospital |
"ROR" |
https://ror.org/01gfeyd95 |
Funders
Funder type
Industry
Government organisation / For-profit companies (industry)
- Alternative name(s)
- 3M Company, 3M Science Applied to Life, 3M Science. Applied to Life. 3M United States, Minnesota Mining and Manufacturing Company
- Location
- United States of America
Results and Publications
| Intention to publish date | 31/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Exact plans unknown but planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from David.Torgerson@york.ac.uk |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V1 | 05/01/2017 | 21/02/2017 | No | Yes |
| Protocol article | protocol | 08/05/2019 | 10/05/2019 | Yes | No |
| Basic results | 06/09/2022 | No | No | ||
| Other publications | An embedded randomised controlled retention trial of personalised text messages compared to non-personalised text messages in an orthopaedic setting | 11/06/2020 | 31/10/2022 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN87127065_PIS_05Jan17_V1.doc
- Uploaded 21/02/2017
- ISRCTN87127065 BasicResults.pdf
Editorial Notes
31/10/2022: Publication reference added.
06/09/2022: The basic results have been uploaded as an additional file.
06/09/2021: The intention to publish date was changed from 30/03/2021 to 31/12/2021.
02/12/2020: The intention to publish date was changed from 30/06/2020 to 30/03/2021.
12/05/2020: The following changes have been made:
1. The overall trial end date has been changed from 30/04/2020 to 07/11/2020.
2. The total final enrolment number has been added.
3. The plain English summary has been updated to reflect the changes above.
10/05/2019: Publication reference added.
16/10/2018: The following changes were made to the trial record:
1. The overall trial end date was changed from 28/02/2020 to 30/04/2020.
2. The intention to publish date was changed from 30/03/2020 to 30/06/2020.
20/08/2018: Internal review.
16/03/2018: The following updates were made:
1. Recruitment end date is updated from 28/02/2018 to 31/08/2018.
2. Overall trial end date is updated from 01/08/2019 to 28/02/2020.
3. Intention to publish date is updated from 31/08/2019 to 30/03/2020.
22/02/2018: Added substudy that is being undertaken as part of a student project that will be reported separately to the main trial. Sub-study hypothesis, interventions and outcome measures added.
05/02/2018: The trial website has been added. The following sites were removed as trial participating sites:
Wansbeck Hospital, Hexham Hospital, North Tyneside Hospital, University Hospital North Durham, Bishop Auckland General Hospital, James Cook University Hospital, Friarage Hospital, Freeman Hospital, Cumberland Infirmary, West Cumberland Infirmary, Sunderland Royal Hospital, Norfolk and Norwich University Hospital, Royal Devon and Exeter Hospital, Royal Orthopaedic Hospital, Russells Hall Hospital, Hospital of St Cross, University Hospital Coventry. The following were added as trial participating centres: Betsi Cadwalder University Health Board, City Hospitals Sunderland NHS Foundation Trust, County Durham and Darlington NHS Foundation Trust, Dorset County Hospital NHS Foundation Trust, East and North Hertfordshire NHS Trust, East Kent Hospitals University NHS Foundation Trust, Gateshead Health NHS Trust, Golden Jubilee National Hospital, Hampshire Hospitals NHS Foundation Trust, Maidstone and Tunbridge Wells NHS Trust, Norfolk and Norwich University Hospital, North Cumbria University Hospitals NHS Foundation Trust,
North Tees and Hartlepool NHS Foundation Trust, Northumbria Healthcare NHS Foundation Trust, Royal Devon and Exeter NHS Foundation Trust, South Tees Hospitals NHS Foundation Trust, Stockport NHS Foundation Trust, Taunton and Somerset NHS Foundation Trust, The Dudley Group NHS Foundation Trust, University Hospital of South Manchester NHS Foundation Trust, Warrington and Halton Hospitals NHS Foundation Trust, Western Sussex Hospitals NHS Foundation Trust , Wrightington, Wigan and Leigh NHS Foundation Trust, and York Teaching Hospital NHS Foundation Trust.
28/02/2017: Ethics approval information added.
21/02/2017: Participant information sheet uploaded.
20/02/2017: Verified study information with principal investigator.
