NCT02253680

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
11 months until next milestone

First Posted

Study publicly available on registry

October 1, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

October 1, 2014

Status Verified

September 1, 2014

Enrollment Period

1 year

First QC Date

September 1, 2013

Last Update Submit

September 30, 2014

Conditions

Osteoarthritis

Keywords

OsteoarthritisTotal knee replacementEnhanced recoveryCompression bandages

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Knee range of motion

    6 months

  • Pain

    6 months

  • Patient satisfaction

    6 months

Other Outcomes (1)

  • Knee ROM

    6 months

Study Arms (2)

Routine care

NO INTERVENTION

Wool and crepe bandage for 24 hours post-operatively

Compression bandage

EXPERIMENTAL

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

Procedure: Actico, short-stretch, inelastic dressing

Interventions

Actico, short-stretch, inelastic dressingPROCEDURE

Worn 24hr post-operatively

Also known as: Compression bandage
Compression bandage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Extensive peripheral vascular disease
  • Lower limb neurological disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Wansbeck District General Hospital

Ashington, Northumberland, NE639JJ, United Kingdom

Location

Northumbria Healthcare NHS Foundation Trust

Ashington, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Compression Bandages

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

BandagesEquipment and Supplies

Study Officials

  • Mike Reed, MD FRCS

    Northumbria NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Trauma and Orthopaedic Surgeon

Study Record Dates

First Submitted

September 1, 2013

First Posted

October 1, 2014

Study Start

November 1, 2013

Primary Completion

November 1, 2014

Study Completion

August 1, 2015

Last Updated

October 1, 2014

Record last verified: 2014-09

Locations

GB(2)