The Use of Compression Bandages in Total Knee Replacement Surgery

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02253680
• Other study ID #: RCTTKR-01
• Status: Active, not recruiting
• Phase: N/A
• First received: September 1, 2013
• Last updated: September 30, 2014
• Start date: November 2013
• Est. completion date: August 2015

Study information

• Verified date: September 2014
• Source: Northumbria Healthcare NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: August 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Procedure:
• Actico, short-stretch, inelastic dressing
Worn 24hr post-operatively

Locations

Country	Name	City	State
United Kingdom	Northumbria Healthcare NHS Foundation Trust	Ashington
United Kingdom	Wansbeck District General Hospital	Ashington	Northumberland

Sponsors (1)

Lead Sponsor	Collaborator
Northumbria Healthcare NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Knee ROM	Circumference of knee 10cm above, at and below patella	6 months	No
Primary	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.	6 months	No
Secondary	Knee range of motion	Range of motion of the knee compared to the pre-operative knee.	6 months	No
Secondary	Pain	Post-operative pain scores measured by visual analogue scale	6 months	No
Secondary	Patient satisfaction	Oxford knee score and EQ-5D scores pre-operatively and at six months	6 months	No