OsteoarthritisNCT02253680
The Use of Compression Bandages in Total Knee Replacement Surgery
A study testing Actico, short-stretch, inelastic dressing in people with Osteoarthritis, run by Northumbria Healthcare NHS Foundation Trust at 2 sites in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Actico, short-stretch, inelastic dressing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Nov 2013to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18
- Able to give written, informed consent
- Primary total knee replacement
Who cannot join
- Extensive peripheral vascular disease
- Lower limb neurological disorder
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Wansbeck District General Hospital
Ashington, Northumberland, NE639JJ
Northumbria Healthcare NHS Foundation Trust
Ashington
About this study
Official title: 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).
- Conditions
- Osteoarthritis
- Being tested
- Actico, short-stretch, inelastic dressing
- Keywords
- Osteoarthritis, Total knee replacement, Enhanced recovery, Compression bandages
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Actico, short-stretch, inelastic dressingProcedure or surgery
Also called Compression bandage
Worn 24hr post-operatively
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Actico, short-stretch, inelastic dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
Knee range of motion
Range of motion of the knee compared to the pre-operative knee.
Measured: 6 months
Pain
Post-operative pain scores measured by visual analogue scale
Measured: 6 months
Patient satisfaction
Oxford knee score and EQ-5D scores pre-operatively and at six months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startNov 2013
- Primary completionNov 2014 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northumbria Healthcare NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mike Reed, Northumbria Healthcare NHS Foundation Trust
- Investigators
- Mike Reed, MD FRCS, Principal investigator, Northumbria NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02253680
- Sponsor's protocol ID
- RCTTKR-01
- Status last verified
- Sep 2014
- First submitted
- 1 Sep 2013
- Last updated
- 1 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomised Control Trial Investigating the Use of a Two-layer, Short-stretch Compression Bandage in Elective Total Knee Replacement - Feasibility
- ClinicalTrials.gov ID
- NCT02253680
- Acronym / sponsor ID
- RCTTKR-01
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, Total knee replacement, Enhanced recovery, Compression bandages
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Northumbria Healthcare NHS Foundation TrustUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 1 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine care | No intervention | –Wool and crepe bandage for 24 hours post-operatively |
| Compression bandage | Experimental | Procedure: Actico, short-stretch, inelastic dressingActico, inelastic, short-stretch compression bandage worn 24 hours post-operatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18
- Able to give written, informed consent
- Primary total knee replacement
Key exclusion criteria (2 listed)
- Extensive peripheral vascular disease
- Lower limb neurological disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Actico, short-stretch, inelastic dressingAlso: Compression bandageWorn 24hr post-operatively | Procedure or surgery | Compression bandage |
Primary outcome
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.
3 secondary outcomes
Knee range of motion
Time frame: 6 months
Pain
Time frame: 6 months
Patient satisfaction
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mike Reed, MD FRCS principal investigator
Northumbria NHS Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Actico, short-stretch, inelastic dressing in people with Osteoarthritis, run by Northumbria Healthcare NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2014.