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The Use of Compression Bandages in Total Knee Replacement Surgery

Primary Purpose

Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Actico, short-stretch, inelastic dressing
Sponsored by
Northumbria Healthcare NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, Total knee replacement, Enhanced recovery, Compression bandages

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age > 18
  • Able to give written, informed consent
  • Primary total knee replacement

Exclusion Criteria:

  • Extensive peripheral vascular disease
  • Lower limb neurological disorder

Sites / Locations

  • Wansbeck District General Hospital
  • Northumbria Healthcare NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Routine care

Compression bandage

Arm Description

Wool and crepe bandage for 24 hours post-operatively

Actico, inelastic, short-stretch compression bandage worn 24 hours post-operatively

Outcomes

Primary Outcome Measures

Feasibility
Additionally, the study is a feasibility study to estimate (via the pilot trial) rates of patient recruitment, randomisation, retention and response, logistics of trial methodology, and resource utilisation.

Secondary Outcome Measures

Knee range of motion
Range of motion of the knee compared to the pre-operative knee.
Pain
Post-operative pain scores measured by visual analogue scale
Patient satisfaction
Oxford knee score and EQ-5D scores pre-operatively and at six months

Full Information

First Posted
September 1, 2013
Last Updated
September 30, 2014
Sponsor
Northumbria Healthcare NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02253680
Brief Title
The Use of Compression Bandages in Total Knee Replacement Surgery
Official Title
A Prospective, Randomised Control Trial Investigating the Use of a Two-layer, Short-stretch Compression Bandage in Elective Total Knee Replacement - Feasibility
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
August 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northumbria Healthcare NHS Foundation Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The use of compression bandages in elective orthopaedic knee surgery is well regarded, however, there is a lack of robust, well-designed evidence to support this. The aim is to determine the feasibility of conducting a randomised control trial comparing the use of a compression bandage worn post-operatively for 24 hours after elective total knee replacement, compared to standard practice (wool and crepe, non-compressive dressing).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Osteoarthritis, Total knee replacement, Enhanced recovery, Compression bandages

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Routine care
Arm Type
No Intervention
Arm Description
Wool and crepe bandage for 24 hours post-operatively
Arm Title
Compression bandage
Arm Type
Experimental
Arm Description
Actico, inelastic, short-stretch compression bandage worn 24 hours post-operatively
Intervention Type
Procedure
Intervention Name(s)
Actico, short-stretch, inelastic dressing
Other Intervention Name(s)
Compression bandage
Intervention Description
Worn 24hr post-operatively
Primary Outcome Measure Information:
Title
Feasibility
Description
Additionally, the study is a feasibility study to estimate (via the pilot trial) rates of patient recruitment, randomisation, retention and response, logistics of trial methodology, and resource utilisation.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Knee range of motion
Description
Range of motion of the knee compared to the pre-operative knee.
Time Frame
6 months
Title
Pain
Description
Post-operative pain scores measured by visual analogue scale
Time Frame
6 months
Title
Patient satisfaction
Description
Oxford knee score and EQ-5D scores pre-operatively and at six months
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Knee ROM
Description
Circumference of knee 10cm above, at and below patella
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age > 18 Able to give written, informed consent Primary total knee replacement Exclusion Criteria: Extensive peripheral vascular disease Lower limb neurological disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mike Reed, MD FRCS
Organizational Affiliation
Northumbria NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wansbeck District General Hospital
City
Ashington
State/Province
Northumberland
ZIP/Postal Code
NE639JJ
Country
United Kingdom
Facility Name
Northumbria Healthcare NHS Foundation Trust
City
Ashington
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

The Use of Compression Bandages in Total Knee Replacement Surgery

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