Condition category
Musculoskeletal Diseases
Date applied
20/02/2017
Date assigned
20/02/2017
Last edited
16/10/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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 April 2020

Who is funding the study?
3M Company (USA)

Who is the main contact?
Mrs Elizabeth Cook
liz.cook@york.ac.uk

Trial website

https://www.york.ac.uk/healthsciences/research/trials/research/trials/krebs/

Contact information

Type

Public

Primary contact

Mrs Elizabeth Cook

ORCID ID

Contact details

University of York
Heslington
York
YO10 5DD
United Kingdom
+44 (0)1904 321522
liz.cook@york.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

32352

Study information

Scientific title

A randomised controlled trial of the effect of a two-layer compression bandage system on knee function following total knee arthroplasty

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

North East - Newcastle & North Tyneside 2 Research Ethics Committee, 08/02/2017, ref: 16/NE/0400

Study design

Randomised; Interventional; Design type: Treatment, Device

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files

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

Phase

Phase III

Drug names

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 trial start date

01/08/2016

Overall trial end date

30/04/2020

Reason abandoned (if study stopped)

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 2600; UK Sample Size: 2600

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

United Kingdom

Trial participating centre

Betsi Cadwalder University Health Board
-
-
United Kingdom

Trial participating centre

City Hospitals Sunderland NHS Foundation Trust
-
-
United Kingdom

Trial participating centre

County Durham and Darlington NHS Foundation Trust
-
-
United Kingdom

Trial participating centre

Dorset County Hospital NHS Foundation Trust
-
-
-
United Kingdom

Trial participating centre

East and North Hertfordshire NHS Trust
-
-
-
United Kingdom

Trial participating centre

East Kent Hospitals University NHS Foundation Trust
-
-
United Kingdom

Trial participating centre

Gateshead Health NHS Trust
-
-
United Kingdom

Trial participating centre

Golden Jubilee National Hospital
-
-
United Kingdom

Trial participating centre

Hampshire Hospitals NHS Foundation Trust
-
-
-
United Kingdom

Trial participating centre

Maidstone and Tunbridge Wells NHS Trust
-
-
-
United Kingdom

Trial participating centre

Norfolk and Norwich University Hospital
-
-
-
United Kingdom

Trial participating centre

North Cumbria University Hospitals NHS Foundation Trust
-
-
-
United Kingdom

Trial participating centre

North Tees and Hartlepool NHS Foundation Trust
-
-
-
United Kingdom

Trial participating centre

Northumbria Healthcare NHS Foundation Trust
-
-
-
United Kingdom

Trial participating centre

Royal Devon and Exeter NHS Foundation Trust
-
-
-
United Kingdom

Trial participating centre

Royal Devon and Exeter NHS Foundation Trust
-
-
-
United Kingdom

Trial participating centre

South Tees Hospitals NHS Foundation Trust
-
-
-
United Kingdom

Trial participating centre

Stockport NHS Foundation Trust
-
-
-
United Kingdom

Trial participating centre

Taunton and Somerset NHS Foundation Trust
-
-
United Kingdom

Trial participating centre

The Dudley Group NHS Foundation Trust
-
-
United Kingdom

Trial participating centre

University Hospital of South Manchester NHS Foundation Trust
-
-
-
United Kingdom

Trial participating centre

Warrington and Halton Hospitals NHS Foundation Trust
-
-
United Kingdom

Trial participating centre

Western Sussex Hospitals NHS Foundation Trust
-
-
United Kingdom

Trial participating centre

Wrightington, Wigan and Leigh NHS Foundation Trust
-
-
-
United Kingdom

Trial participating centre

York Teaching Hospital NHS Foundation Trust
-
-
United Kingdom

Sponsor information

Organisation

Northumbria Healthcare NHS Foundation Trust

Sponsor details

Wansbeck Hospital
Woodhorn Lane
Ashington
NE68 6JJ
United Kingdom
+44 (0)344 811 8111
contactus@northumbria.nhs.uk

Sponsor type

Hospital/treatment centre

Website

https://www.northumbria.nhs.uk/our-locations/wansbeck-general-hospital

Funders

Funder type

Industry

Funder name

3M

Alternative name(s)

3M Company

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Results and Publications

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

Intention to publish date

30/06/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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.