The Use of Compression Bandages in Total Knee Replacement Surgery

September 30, 2014 updated by: Mike Reed, Northumbria Healthcare NHS Foundation Trust

A Prospective, Randomised Control Trial Investigating the Use of a Two-layer, Short-stretch Compression Bandage in Elective Total Knee Replacement - Feasibility

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Ashington, United Kingdom
        • Northumbria Healthcare NHS Foundation Trust
    • Northumberland
      • Ashington, Northumberland, United Kingdom, NE639JJ
        • Wansbeck District General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Extensive peripheral vascular disease
  • Lower limb neurological disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Routine care
Wool and crepe bandage for 24 hours post-operatively
Experimental: Compression bandage
Actico, inelastic, short-stretch compression bandage worn 24 hours post-operatively
Procedure: Actico, short-stretch, inelastic dressing
Worn 24hr post-operatively
Other Names:
  • Compression bandage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility
Time Frame: 6 months
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee range of motion
Time Frame: 6 months
Range of motion of the knee compared to the pre-operative knee.
6 months
Pain
Time Frame: 6 months
Post-operative pain scores measured by visual analogue scale
6 months
Patient satisfaction
Time Frame: 6 months
Oxford knee score and EQ-5D scores pre-operatively and at six months
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee ROM
Time Frame: 6 months
Circumference of knee 10cm above, at and below patella
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northumbria Healthcare NHS Foundation Trust

Investigators

  • Principal Investigator: Mike Reed, MD FRCS, Northumbria NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Anticipated)

November 1, 2014

Study Completion (Anticipated)

August 1, 2015

Study Registration Dates

First Submitted

September 1, 2013

First Submitted That Met QC Criteria

September 30, 2014

First Posted (Estimate)

October 1, 2014

Study Record Updates

Last Update Posted (Estimate)

October 1, 2014

Last Update Submitted That Met QC Criteria

September 30, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCTTKR-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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