Condition category
Musculoskeletal Diseases
Date applied
11/02/2015
Date assigned
11/02/2015
Last edited
15/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Knee replacement is a common operation for patients with osteoarthritis. It is a major operation with a long recovery period. Physiotherapy is an important part of the recovery process because it can help improve strength and movement in the replaced knee and allow people to gain the maximum benefit from the operation. However, not all hospitals offer physiotherapy to patients once they have been discharged after their knee replacement operation. In this study, we will find out whether it is helpful to offer exercise classes to patients following knee replacement.

Who can participate?
Adult (aged at least 18) NHS patients about to have a total knee replacement due to osteoarthritis at Southmead Hospital or Emersons Green Treatment Centre (UK).

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 receive usual care after their knee replacement where they are given a leaflet about exercise and referred to outpatient physiotherapy on a needs only basis i.e. if they have poor mobility. Those in group 2 are invited to attend an exercise class, in addition to receiving ‘usual care’. This class is run every week for six weeks, starting at six weeks after knee replacement surgery. In the class, patients practice task related exercises such as walking, stair climbing, and kneeling. Each patient is also given two individualised exercises, designed by the physiotherapist, to help address specific goals. We ask everyone in the study to complete questionnaires during the first year after surgery to see if the exercise classes improve their mobility. We also collect information to compare the cost of providing both treatments. The findings from this study will help us to know if providing outpatient exercises classes can improve patient’s mobility up to one year after knee replacement surgery and is good value for money to invest NHS resources.

What are the possible benefits and risks of participating?
Patients participating in the exercise class may gain some functional benefit from regular specific exercises. However we do not know whether the exercise class will provide any benefit over usual care
Risks include the physical risks of undertaking exercise. Many patients will continue to have some ongoing pain and functional limitations in the first 3 months after their knee replacement. Participation in the exercise class has the potential to cause further pain and tissue injury or exacerbate existing pain. Although these risks are likely to be small, every attempt to minimize these risks will made. Participants in the exercise class will be monitored throughout the duration of the class and all adverse events will be documented. All exercises will be demonstrated and participants will be advised on how to exercise safely. If the physiotherapists are concerned about a participant then they will contact the participant's consultant orthopaedic surgeon following discussion with the participant.

Where is the study run from?
Southmead Hospital and Emersons Green Treatment Centre (UK)

When is the study starting and how long is it expected to run for?
March 2015 to June 2016

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Mrs Nabeela Iqbal

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Nabeela Iqbal

ORCID ID

Contact details

Southmead Hospital
Southmead Road
Westbury-On-Trym
Bristol
BS10 5NB
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

18286

Study information

Scientific title

Effectiveness and cost-effectiveness of outpatient physiotherapy after knee replacement: a randomised controlled trial

Acronym

ARENA

Study hypothesis

The aim of this study is to find out whether it is helpful to offer exercise classes to patients following knee replacement.

Ethics approval

NRES Committee South West – Central Bristol, 19/01/2015, ref: 14/SW/1144

Study design

Randomised; Interventional; Design type: Not specified

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a patient information sheet

Condition

Topic: Surgery; Subtopic: Surgery; Disease: All Surgery

Intervention

Outpatient physiotherapy: Six week group-based outpatient physiotherapy course consisting of task-related and individualised exercises, starting 6 weeks after total knee replacement surgery.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Lower Extremity Functional Scale (LEFs) at 12 months after surgery

Secondary outcome measures

1. EQ-5D-5L at 2 weeks, 3 months, 6 months and 12 months after surgery
2. LEFS at 3 months and 6 months after surgery
3. Knee Injury and Osteoarthritis Outcome Score (KOOS) at 3 months, 6 months and 12 months after surgery
4. Self-Administered Patient Satisfaction Scale for Primary Hip and Knee Arthroplasty at 3 months, 6 months and 12 months after surgery
5. Likert-type scale for satisfaction with physiotherapy treatment received at 3 months, 6 months and 12 months after surgery
6. Hospital Anxiety and Depression Scale at 3 months, 6 months and 12 months after surgery

Overall trial start date

01/11/2014

Overall trial end date

31/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. NHS patients listed for primary total knee replacement due to osteoarthritis at Southmead Hospital or Emersons Green Treatment Centre
2. Male & Female
3. Lower Age Limit 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 256; UK Sample Size: 256

Participant exclusion criteria

1. Patients listed for total knee replacement for reasons other than osteoarthritis
2. Patients listed for revision total knee replacement
3. Patients unable or unwilling to attend physiotherapy classes if randomised to the intervention group
4. Inability to participate in exercise for medical reasons such as unstable cardiovascular or severe neurological conditions
5. Unable or unwilling to provide informed consent
6. Inability to understand English because not all the questionnaires have been translated and validated into other languages
7. Post-operative complication(s) within the first two weeks of surgery which would preclude participation in the physiotherapy class e.g. prosthetic joint infection, manipulation under anaesthetic

Recruitment start date

01/03/2015

Recruitment end date

01/06/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Southmead Hospital
Southmead Road Westbury-On-Trym
Bristol
BS10 5NB
United Kingdom

Trial participating centre

Emersons Green NHS Treatment Centre
The Brooms Emersons Green
Bristol
BS16 7FH
United Kingdom

Sponsor information

Organisation

North Bristol NHS Trust

Sponsor details

Research & Innovation
Floor 3 Learning & Research Building
Southmead Hospital
Bristol
BS10 5NB
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The trial protocol will be submitted for publication in an open access journal by Spring 2015. After the trial is complete, manuscripts presenting the clinical and cost-effectiveness results will be submitted to relevant peer-review journals. Results will also be submitted for presentation at a national or international conference.

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27296366

Publication citations

Additional files

Editorial Notes

14/06/2016: Publication reference added.