Condition category
Musculoskeletal Diseases
Date applied
02/11/2016
Date assigned
16/11/2016
Last edited
16/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The anterior cruciate ligament (ACL) is a tough band of tissue in the middle of the knee, preventing the shin bone (tibia) from sliding out in front of the thigh bone (femur). It is one of the four main ligaments within the knee, and the most common to be injured. An ACL rupture is a common knee injury, which often occurs during high-intensity sports such as football or basketball. They happen when the ACL in the knee is over-stretched and becomes torn (ruptured). This causes the knee joint to become very unstable and can make some types of movement very difficult. There are two main NHS treatment options for this problem, non-surgical treatment using physiotherapy or an operation to replace the ligament (ACL reconstruction). This lack of research means that treatment varies between surgeons and hospitals. Some doctors feel that all patients should undergo surgery and as soon as possible to stabilise the joint, prevent buckling and stop any further damage. At least 13,941 of these operations were performed in the UK last year (although other records suggest a figure closer to 50,000). The costs of ACL surgery to the NHS amount to about £60 million per year. Others feel that blanket referral for operative treatment is controversial as surgery may not always be necessary. It is known that a stable knee can be achieved in many patients by using physiotherapy exercises. Some therefore feel that a rehabilitation programme should always be tried first before considering surgery. The aim of this study is to determine the best treatment for ACL rupture.

Who can participate?
Adults who injured themselves at least four months ago who have an ACL rupture.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive regular physiotherapy sessions under the care of clinicians who specialise in this injury. The sessions work on improving the strength of leg muscles, balance and ability to return to activities. Those in the second group undergo ACL reconstruction surgery. This involves an operation where the torn ligament is replaced with a graft (tissue taken from a tendon in another part of the knee). In both groups, the treatments provided are the standard treatments offered at that particular hospital. All patients participating in this study attend follow up visits and are monitored at their local hospital as they would normally following physiotherapy or surgery. If any problems are experienced a re-view appointment is arranged with the clinical team to discuss future management. If further treatment is needed, this is also arranged. Participants are asked to complete an email or paper follow up questionnaire at 6, 12 and 18 months afterward. The questionnaires ask for information about their injured knee and the associated impact of this on quality of life. Patients may also be contacted by one of our researchers and invited to discuss their experiences of the treatment.

What are the possible benefits and risks of participating?
There are no direct benefits of participating however the information gained from participation could lead to improving future treatments for patients with ACL injury. There are no anticipated risks or disadvantages to participating in this study.

Where is the study run from?
At least 15 NHS hospitals in England and Wales (UK)

When is the study starting and how long is it expected to run for?
January 2014 to April 2021

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

Who is the main contact?
1. Professor David Beard (scientific)
david.beard@ndorms.ox.ac.uk
2. Mr Carlos Areia (public)
carlos.morgadoareia@ndorms.ox.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof David Beard

ORCID ID

Contact details

Surgical Intervention Trials Unit
NDORMS
Botnar Research Centre
University of Oxford
Nuffield Orthopaedic Centre
Windmill Road
Oxford
OX3 7LD
United Kingdom
+44 1865 737929
david.beard@ndorms.ox.ac.uk

Type

Public

Additional contact

Mr Carlos Areia

ORCID ID

http://orcid.org/0000-0002-4668-7069

Contact details

Surgical Intervention Trials Unit
NDORMS
Botnar Research Centre
University of Oxford
Nuffield Orthopaedic Centre
Windmill Road
Oxford
OX3 7LD
United Kingdom
+44 1865 227715
carlos.morgadoareia@ndorms.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

31501

Study information

Scientific title

Comparison of the clinical and cost effectiveness of two management strategies for non-acute Anterior Cruciate Ligament (ACL) injury: Rehabilitation versus surgical Reconstruction

Acronym

ACL SNNAP

Study hypothesis

The aim of this study is to determine in patients with non-acute (greater than 4 months since injury) Anterior Cruciate Ligament Deficiency (ACLD) whether a strategy of non-surgical management [physiotherapy rehabilitation with option for later ACL reconstruction only if required) is more clinically effective and cost effective than a strategy of surgical management (reconstruction).

Ethics approval

South Central – Oxford C Research Ethics Committee, 12/10/2016, ref: 16/SC/0502

Study design

Randomised; Interventional; Design type: Treatment, Process of Care, Education or Self-Management, Complex Intervention, Physical, Management of Care, Surgery, Rehabilitation

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See word doc.

Condition

Specialty: Musculoskeletal disorders, Primary sub-specialty: Elective orthopaedic surgery; UKCRC code/ Disease: Musculoskeletal/ Other disorders of the musculoskeletal system and connective tissue

Intervention

Both interventions are routine NHS treatments. Intervention content is based on a minimal set of pre-established criteria in order to ensure the integrity of the comparison while allowing for varying in practice in delivering the interventions between both surgeons and physiotherapists. This largely pragmatic approach will allow clinical management to reflect current practice and resource use within the NHS thus aiding generalisation. Participants will be allocated a study number and randomised on a 1:1 basis to receive one of two management options, non-surgical management (Rehabilitation) or surgery (Reconstruction). Randomisation will be performed using a web based automated computer generated system and will be stratified by site and baseline KOOS(4) to ensure balance across groups.

Non-surgical management (Rehabilitation): Routine ACL rehabilitation protocols used at participating sites will be followed. As part of the site selection process, documentary evidence of the use of or willingness to adopt a rehabilitation protocol that reflects the guidelines of the mandatory aims/goals set for the study rehabilitation intervention will be required.

Surgical Management (Reconstruction): All surgical reconstructions will be patella tendon or hamstrings tendon depending on the surgeon’s preference. All other care will be routine, including immediate post-operative care.

Other than the allocated intervention, both groups will be followed-up in the same way to exclude bias. Follow up for study purposes will be by patient self-reported questionnaire completed using an electronic data capture collection system (a postal option will also be available). The questionnaire will include the outcomes indicated in section 4 and will be completed by participants at baseline, 6, 12 and 18 months. Non-response will be minimised through use of multiple reminders such as web based, phone and text.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Knee injury and Osteoarthritis Outcome Score (KOOS4) is meaured at at baseline, 6, 12 and 18 months.

Secondary outcome measures

1. Return to activity/level of sports is measured by the Modified Tegner scale at baseline and 6, 12 and 18 months
2. Generic quality of life is measured using EuroQol EQ-5D at baseline and 6, 12 and 18 months
3. Knee specific quality of life is measured using the KOOS (all subscales, the fifth scale being activities of daily living) and Anterior Cruciate Ligament Quality of Life score (ACL-QOL) at baseline and 6, 12 and 18 months
4. Intervention related complications is determined as any complications associated with undergoing ACL deficiency treatment*, recorded at 6, 12 and 18 months
5. Resource usage data on initial treatments received and subsequent healthcare costs such as re-operations, subsequent surgical reconstructions, surgery related complications, further rehabilitation, and primary and other secondary care contacts, ability to work (e.g. sickness absences/return to work number of days off work and subjective working ability) is collected at baseline and 6, 12 and 18 months
6. Expectations of return to activity and confidence in relation to the knee is measured by the Anterior Cruciate Ligament Quality of Life score (ACL-QOL) at baseline and 6, 12 and 18 months
7. Patient satisfaction with the outcome of treatment is measured using a simple Likert scale at 6, 12 and 18 months

*This includes; for surgery group; re-admission, delayed hospital discharge, infection, unexpected poor range of movement (stiffness), excess bleeding, continued swelling, episodes of giving way, continued feeling of instability. For non-surgical group; continued swelling, episodes of giving way.

Overall trial start date

10/01/2014

Overall trial end date

01/04/2021

Reason abandoned

Eligibility

Participant inclusion criteria

1. Participant is willing and able to give informed consent for participation in the study
2. Male or Female, aged 18 years or above
3. Symptomatic ACL deficiency (instability-episodes of frank giving way or feeling unstable) with ACL deficiency confirmed using clinical assessment and MRI scan

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 320; UK Sample Size: 320

Participant exclusion criteria

1. Less than 4 months since injury
2. Previous knee surgery (other than diagnostic arthroscopy)to index knee, concomitant severe injury to contra-lateral knee
3. Meniscal pathology considered sufficiently symptomatic to require surgery i.e. locked knee, large bucket handle cartilage tear
4. Knee joint status is grade 3-4 on the Kellgren and Lawrence scale
5. Inflammatory arthropathy
6. Grade 3 MCL/LCL injury, associated PCL/PLC injury
7. Pregnancy

Recruitment start date

01/12/2016

Recruitment end date

01/12/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Nuffield Orthopaedic Centre NHS Trust
Oxford University Hospitals NHS Foundation Trust Windmill Road Headington
Oxford
OX3 7LD
United Kingdom

Trial participating centre

Royal Berkshire Hospital
Royal Berkshire NHS Foundation Trust London Road
Reading
RG1 5AN
United Kingdom

Trial participating centre

King’s Mill Hospital
Sherwood Forest Hospitals NHS Foundation Trust Mansfield Road
Sutton-in-Ashfield
NG17 4JL
United Kingdom

Trial participating centre

University Hospital of Wales
Cardiff and Vale NHS Trust Heath Park
Cardiff
CF14 4XW
United Kingdom

Trial participating centre

Great Western Hospital
Great Western Hospitals NHS Foundation Trust Marlborough Road
Swindon
SN3 6BB
United Kingdom

Trial participating centre

Yeovil District Hospital
Yeovil District Hospital NHS Foundation Trust Higher Kingston
Yeovil
BA21 4AT
United Kingdom

Trial participating centre

Ipswich Hospital
Ipswich Hospital NHS Trust Heath Road
Ipswich
IP4 5PD
United Kingdom

Trial participating centre

University College London Hospital
London Hospitals NHS Foundation Trust 250 Euston Road
London
NW1 2PG
United Kingdom

Trial participating centre

Leicester General Hospital
University Hospitals of Leicester NHS Trust Gwendolen House Gwendolen Road
Leicester
LE5 4QF
United Kingdom

Trial participating centre

Hull Royal Infirmary
Hull and East Yorkshire Hospitals NHS Trust Anlaby Road
Hull
HU3 2JZ
United Kingdom

Trial participating centre

Queen Alexandra Hospital
Portsmouth Hospitals NHS Trust Southwick Hill Road
Portsmouth
PO6 3LY
United Kingdom

Trial participating centre

Frimley Park Hospital
Frimley Park Hospitals NHS Foundation Trust Portsmouth Road
Frimley
GU16 7UJ
United Kingdom

Trial participating centre

Morriston Hospital
Abertawe Bro Morgannwg University Health Board Morriston Heol Maes Eglwys
Swansea
SA6 6NL
United Kingdom

Trial participating centre

Northern General Hospital
Sheffield Teaching Hospitals NHS Foundation Trust Herries Road
Sheffield
S5 7AU
United Kingdom

Trial participating centre

University Hospital Coventry
University Hospitals Coventry and Warwickshire NHS Trust Walsgrave General Hospital Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Sponsor information

Organisation

University of Oxford

Sponsor details

Clinical Trials and Research Governance
Joint Research Office
Block 60
Churchill Hospital
Headington
Oxford
OX3 7LE
United Kingdom

Sponsor type

University/education

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

Publications will include a final report, as well as presentations at scientific meetings and publication of findings in scientific literature. All will be published in line with NIHR guidance. The trial protocol will be published in 2017 and the main trial results paper in 2021. In addition, all participants in the trial will be sent a summary of the final results written in plain English and details of where to find further information.

IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2021

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes