Condition category
Musculoskeletal Diseases
Date applied
20/02/2017
Date assigned
20/02/2017
Last edited
28/02/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
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 hypothesised 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.

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.

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 August 2019

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

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

Trial website

http://krebsnhs.weebly.com/

Contact information

Type

Public

Primary contact

Mrs Elizabeth Cook

ORCID ID

Contact details

University of York
Heslington
York
YO10 5DD
United Kingdom
+44 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.

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.

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

Patient reported knee function and pain is measured using the Oxford Knee Score at baseline (pre-operatively), 12 months post-operatively.

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

Overall trial start date

01/08/2016

Overall trial end date

01/08/2019

Reason abandoned

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

28/02/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Wansbeck Hospital
Woodhorn Lane
Ashington
NE63 9JJ
United Kingdom

Trial participating centre

Hexham Hospital
Corbridge Road
Hexham
NE46 1QJ
United Kingdom

Trial participating centre

North Tyneside Hospital
Rake Lane
North Shields
NE29 8NH
United Kingdom

Trial participating centre

University Hospital North Durham
North Road
Durham
DH1 5TW
United Kingdom

Trial participating centre

Bishop Auckland General Hospital
Cockton Hill Road
Bishop Auckland
DL14 6AD
United Kingdom

Trial participating centre

James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Trial participating centre

Friarage Hospital
Northallerton
Middlesbrough
DL6 1JG
United Kingdom

Trial participating centre

Freeman Hospital
Freeman Road High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom

Trial participating centre

Cumberland Infirmary
Newtown Road
Carlisle
CA2 7HY
United Kingdom

Trial participating centre

West Cumberland Infirmary
Homewood Road
Whitehaven
CA28 8JG
United Kingdom

Trial participating centre

Sunderland Royal Hospital
Kayll Road
Sunderland
SR4 7TP
United Kingdom

Trial participating centre

Norfolk and Norwich University Hospital
Colney Lane
Norwich
NR4 7UY
United Kingdom

Trial participating centre

Royal Devon and Exeter Hospital
Barrack Road
Exeter
EX2 5DW
United Kingdom

Trial participating centre

Royal Orthopaedic Hospital
The Woodlands Bristol Road South
Birmingham
B31 2AP
United Kingdom

Trial participating centre

Russells Hall Hospital
Pensnett Road
Dudley
DY1 2HQ
United Kingdom

Trial participating centre

Hospital of St Cross
Barby Road
Rugby
CV22 5PX
United Kingdom

Trial participating centre

University Hospital Coventry
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Sponsor information

Organisation

Northumbria Healthcare NHS Foundation Trust

Sponsor details

Wansbeck Hospital
Woodhorn Lane
Ashington
NE68 6JJ
United Kingdom
+44 344 811 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 Company

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Exact plans unknown but planned publication in a high-impact peer reviewed journal. Publication date expected to be August 2019.

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

31/08/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

28/02/2017: Ethics approval information added. 21/02/2017: Participant information sheet uploaded. 20/02/2017: Verified study information with principal investigator.