About the Project
What is KReBS?
KReBS (Knee Replacement Bandaging Study) is a randomised controlled trial looking at patient reported outcome measures following total knee replacement and the application of a compression bandage versus standard wool and crepe bandaging.
Background
Swelling around the knee commonly occurs following total knee replacement. In many papers swelling has been shown to cause decreased knee extension strength as well as function. Compression bandaging has been shown to improve knee flexion, patients pain and rehabilitation process following total knee replacement. It is hypothesised that the increased pressure from the compression causes a tamponade effect decreasing blood loss and thus swelling.
We aim to show that these beneficial effects have an advantageous outcome for patients by looking at patient reported outcome measures following the use of compression bandaging.
Methodology
Objectives
To assess the clinical and cost-effectiveness of a two layer compression bandage compared to standard wool and crepe bandage post-operatively on patient reported outcomes in total knee arthroplasty patients
Outcomes
Primary:
Timeline
About the bandage - Coban 2
Approvals and Registration
Sponsor
Northumbria Healthcare NHS Foundation Trust
c/o Caroline Potts
North Tyneside General Hospital
Rake Lane
North Shields
NE29 8NH
Telephone: 191 293 4087
Email: [email protected]
Funder
3M (USA)
Chief Investigator
Mr Mike Reed, Consultant Trauma & Orthopaedic Surgeon
Northumbria Healthcare NHS Foundation Trust
Wansbeck General Hospital
Woodhorn Lane
Ashington
Northumberland
NE63 9JJ
Collaborating Institution
York Trials
University of York
Heslington
York
YO10 5DD
KReBS (Knee Replacement Bandaging Study) is a randomised controlled trial looking at patient reported outcome measures following total knee replacement and the application of a compression bandage versus standard wool and crepe bandaging.
Background
Swelling around the knee commonly occurs following total knee replacement. In many papers swelling has been shown to cause decreased knee extension strength as well as function. Compression bandaging has been shown to improve knee flexion, patients pain and rehabilitation process following total knee replacement. It is hypothesised that the increased pressure from the compression causes a tamponade effect decreasing blood loss and thus swelling.
We aim to show that these beneficial effects have an advantageous outcome for patients by looking at patient reported outcome measures following the use of compression bandaging.
Methodology
- Sample size: 2600 patients
- 14 centres nationwide
- Multisurgeon
- Pragmatic
- 2 arm
- Randomised controlled trial
- 12 month recruitment window
- Simple randomisation via internet or York trials unit
Objectives
To assess the clinical and cost-effectiveness of a two layer compression bandage compared to standard wool and crepe bandage post-operatively on patient reported outcomes in total knee arthroplasty patients
Outcomes
Primary:
- 12 month Oxford Knee score
- OKS at six months post randomisation.
- EQ-5D-3L index score at six months post randomisation.
- EQ-5D-3L index score at twelve months post randomisation.
- EQ-5D-5L index score at twelve months post randomisation.
- Pain scores at 10 days, 4 weeks and 12 months post randomisation.
- Length of hospital stay.
- PE/DVT rate within 30 days surgery requiring inpatient hospitalisation
Timeline
- HRA/Ethics approval
- 12 month recruitment window
- 12 month follow up
- 6 month data collection and write up
About the bandage - Coban 2
- Manufactured by 3M
- CE marked for use in Venous ulcers, Lymphoedema and other conditions where compression is appropriate
- 2 layer system: Inner comfort layer made from foam and outer compression layer which contains short stretch inelastic material that creates compression
- Advantages of use include low bulk and comfort and thus ease of range of movement. It is tolerable overnight due to its low resting pressure, yet produces high pressure with movement to greatly improve the efficacy of the calf muscle pump and aid swelling reduction.
- This will be applied in theatre and will stay in situ for between 24-48 hours.
Approvals and Registration
- Ethics: REC 16/NE/0400
- IRAS: 212212
- Trial Registration: ISRCTN87127065
Sponsor
Northumbria Healthcare NHS Foundation Trust
c/o Caroline Potts
North Tyneside General Hospital
Rake Lane
North Shields
NE29 8NH
Telephone: 191 293 4087
Email: [email protected]
Funder
3M (USA)
Chief Investigator
Mr Mike Reed, Consultant Trauma & Orthopaedic Surgeon
Northumbria Healthcare NHS Foundation Trust
Wansbeck General Hospital
Woodhorn Lane
Ashington
Northumberland
NE63 9JJ
Collaborating Institution
York Trials
University of York
Heslington
York
YO10 5DD