Anterior Cruciate Ligament InjuryACL SNNAPNCT02980367
ACL SNNAP Trial: ACL Surgery Necessity in Non Acute Patients
A study testing Non-Surgical Management (Rehabilitation) and Surgical Management (Reconstruction) in people with Anterior Cruciate Ligament Injury, run by University of Oxford at 32 sites in United Kingdom.
Trial summary
The primary objective of this study is to determine in patients with non-acute Anterior Cruciate Ligament Deficiency (ACLD) whether a strategy of non-surgical management [Rehabilitation] (with option for later ACL reconstruction, only if required) is more clinically effective and cost effective than a strategy of… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Anterior Cruciate Ligament Injury
- What is being tested?
- Non-Surgical Management (Rehabilitation) and Surgical Management (Reconstruction)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 32 sitesUnited Kingdom
- Study dates
- Dec 2016to Mar 2022
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Symptomatic ACL deficiency of the native ligament1 (instability-episodes of frank giving way or feeling unstable) with ACL deficiency (either partial or complete tear) confirmed using clinical assessment and MRI scan.
Who cannot join
- Acute phase of primary ACL injury i.e. not recovered from any acute symptoms relating to their initial ACL injury.
- Previous knee surgery (other than diagnostic arthroscopy or partial meniscectomy) to index knee concomitant severe injury to contra-lateral knee.
- Meniscal pathology with characteristics that indicate immediate surgery i.e. locked knee, large bucket handle or complex cartilage tear producing mechanical symptoms.
- Knee joint status of grade 3 or 4 on the Kellgren and Lawrence scale,
- Grade 3 MCL/LCL injury, associated PCL/PLC injury
- Inflammatory arthropathy.
- Pregnancy.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United Kingdom32 sites, 32 recruiting
- Recruiting
Betsi Cadwaladr University Health Board
Bangor
- Recruiting
Basildon and Thurrock University Hospitals NHS Foundation Trust
Basildon
Sean Symons
- Recruiting
North Bristol NHS Trust
Bristol
James Murray
- Recruiting
Gloucestershire Hospitals NHS Foundation Trust
Cheltenham
- Recruiting
Countess of Chester Hospital NHS Foundation Trust
Chester
Raghuram Thonse
- Recruiting
University Hospitals Coventry and Warwickshire NHS Trust
Coventry
- Recruiting
Frimley Health NHS Foundation Trust
Frimley
- Recruiting
Royal Surrey County Hospitals NHS Foundation Trust
Guildford
Oliver Templeton-Ward
- Recruiting
Hull and East Yorkshire Hospitals NHS Trust
Hull
Reza Mayahi
- Recruiting
Leeds Teaching Hospitals NHS Trust
Leeds
- Recruiting
University Hospitals of Leicester
Leicester
- Recruiting
Kings College Hospital NHS Foundation Trust
London
Barry Andrews
- Recruiting
University College London Hospitals NHS Foundation Trust
London
- Recruiting
Manchester University NHS Foundation Trust
Manchester
Pankaj Sharma
- Recruiting
Oxford University Hospitals NHS Foundation Trust
Oxford
- Recruiting
North West Anglia NHS Foundation Trust
Peterborough
- Recruiting
Portsmouth Hospitals NHS Trust
Portsmouth
Jeremy Rushbrook
- Recruiting
Royal Berkshire NHS Foundation Trust
Reading
- Recruiting
Salisbury NHS Foundation Trust
Salisbury
Leonidas Vachtsevanos
- Recruiting
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield
- Recruiting
Frimley Health NHS Foundation Trust
Slough
- Recruiting
Stockport NHS Foundation Trust
Stockport
David Johnson
- Recruiting
Sherwood Forest Hospitals NHS Foundation Trust
Sutton in Ashfield
- Recruiting
Abertawe Bro Morannwg University Health Board
Swansea
- Recruiting
Great Western Hospitals NHS Foundation Trust
Swindon
- Recruiting
Taunton and Somerset NHS Foundation Trust
Taunton
Andrew Kelly
- Recruiting
Royal Cornwall Hospitals NHS Trust
Truro
Robin Kincaid
- Recruiting
The Mid Yorkshire Hospitals NHS Trust
Wakefield
Jon Smith
- Recruiting
Warrington and Halton Hospitals NHS Foundation Trust
Warrington
- Recruiting
Wrightington, Wigan and Leigh NHS Foundation Trust
Wigan
Ben Coupe
- Recruiting
Betsi Cadwaladr University Health Board
Wrexham
Yeogesh Joshi
- Recruiting
Yeovil District Hospital NHS Foundation Trust
Yeovil
About this study
Official title: Comparison of the Clinical and Cost Effectiveness of Two Management Strategies for Non-acute Anterior Cruciate Ligament (ACL) Injury: Rehabilitation Versus Surgical Reconstruction.
The primary objective of this study is to determine in patients with non-acute Anterior Cruciate Ligament Deficiency (ACLD) whether a strategy of non-surgical management [Rehabilitation] (with option for later ACL reconstruction, only if required) is more clinically effective and cost effective than a strategy of surgical management [Reconstruction].
Read the detailed description
The ACL SNNAP study is a pragmatic multi-centre randomised controlled trial with two-arm parallel groups and 1:1 allocation ratio to compare non-surgical management (Rehabilitation) and surgical management (Reconstruction) options for patients with a symptomatic non-acute ACL deficient knee.
The objective is to determine, in patients with non-acute Anterior Cruciate Ligament Deficiency (ACLD), whether non-surgical treatment (with the option for later ACL reconstruction if required) is more effective than surgical ACL reconstruction (as measured by the Knee Injury and Osteoarthritis Outcome Score [KOOS4] at 18 months from randomisation).
Target sample size is 320 patients recruited from approx. 30 NHS orthopaedic units.
An internal pilot will be conducted with clear progression criteria regarding recruitment.
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.
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.
Neither participants nor health care practitioners (surgeons and physiotherapists) can be blinded to receipt of the intervention.
- Conditions
- Anterior Cruciate Ligament Injury
- Being tested
- Non-Surgical Management (Rehabilitation), Surgical Management (Reconstruction)
- Keywords
- Anterior Cruciate Ligament, ACL, Anterior Cruciate Ligament deficiency, ACL deficiency, ACLD, Anterior Cruciate Ligament reconstruction, ACL reconstruction, Anterior Cruciate Ligament physiotherapy, Anterior Cruciate Ligament rehabilitation, ACL physiotherapy, ACL rehabilitation, Anterior Cruciate Ligament management, ACL management
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Surgical Management (Rehabilitation)Other
Also called Physical Therapy, Physiotherapy, Conservative Rehabilitation, Conservative Management
Routine ACL rehabilitation protocols used at the participating site 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)Procedure or surgery
Also called ACL Reconstruction, ACLR, ACL surgery, Anterior Cruciate Ligament Surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| ACL Rehabilitation Group | Experimental | Non-surgical management [Rehabilitation] with option for later Anterior Cruciate Ligament (ACL) reconstruction, only if required. Receives: Other: Non-Surgical Management (Rehabilitation) |
| ACL Reconstruction Group | Active comparator | Surgical Management - Anterior Cruciate Ligament (ACL) reconstruction surgery Receives: Procedure: Surgical Management (Reconstruction) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Injury and Osteoarthritis Outcome Score (KOOS4)
The score is derived from 4 of 5 subscales; pain, symptoms, difficulty in sports and recreational activities, knee related quality of life.
Measured: 18 months post randomisation
Secondary outcomes (7)
Knee Injury and Osteoarthritis Outcome Score (KOOS)
All 5 subscales of the KOOS will be included (the fifth scale being activities of daily living).
Anterior Cruciate Ligament Quality of Life Score (ACL-QOL)
Measured: At baseline and at 6, 12 and 18 months post randomisation
Modified Tegner scale
Activity level will be assessed using the Modified Tegner scale, graded from 1 (low activity levels) to 10 (professional level).
Measured: At baseline and at 6, 12 and 18 months post randomisation
Intervention related complications
Any complications associated with undergoing ACL deficiency treatment will be recorded. 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.
Measured: At 6, 12 and 18 months post randomisation
EuroQol EQ-5D-5L
Generic quality of life (self-reported outcome measure covering 5 health domains and used to facilitate the calculation of Quality Adjusted Life Years in health economic evaluations).
Measured: At baseline and at 6, 12 and 18 months post randomisation
Resource-usage data
Detailed resource use data on initial treatments received (surgical reconstruction or rehabilitation) and on subsequent healthcare contacts including re-operations (surgery arm), subsequent surgical reconstructions (rehabilitation arm), surgery-related complications, further rehabilitation, and primary care and other secondary care contacts out to 18 months post-randomisation. In addition, data will be collected on ability to work (e.g. sickness absences/return to work number of days off work and subjective working ability).
Measured: 18 months post randomisation
Anterior Cruciate Ligament Quality of Life score (ACL-QOL)
Expectations of return to activity and confidence in relation to the knee.
Measured: At baseline and at 6, 12 and 18 months post randomisation
Patient satisfaction
Simple Likert scale
Measured: At baseline and at 6, 12 and 18 months post randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionNov 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuryStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Beard, DPhil, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980367
- Sponsor's protocol ID
- 12096
- Acronym
- ACL SNNAP
- Status last verified
- Nov 2020
- First submitted
- 17 Nov 2016
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Beard DJ, Davies L, Cook JA, Stokes J, Leal J, Fletcher H, Abram S, Chegwin K, Greshon A, Jackson W, Bottomley N, Dodd M, Bourke H, Shirkey BA, Paez A, Lamb SE, Barker KL, Phillips M, Brown M, Lythe V, Mirza B, Carr A, Monk P, Areia CM, O'Leary S, Haddad F, Wilson C, Price A; ACL SNNAP Study Group. Comparison of surgical or non-surgical management for non-acute anterior cruciate ligament injury: the ACL SNNAP RCT. Health Technol Assess. 2024 Jun;28(27):1-97. doi: 10.3310/VDKB6009.
PubMed 38940695Beard DJ, Davies L, Cook JA, Stokes J, Leal J, Fletcher H, Abram S, Chegwin K, Greshon A, Jackson W, Bottomley N, Dodd M, Bourke H, Shirkey BA, Paez A, Lamb SE, Barker K, Phillips M, Brown M, Lythe V, Mirza B, Carr A, Monk P, Morgado Areia C, O'Leary S, Haddad F, Wilson C, Price A; ACL SNNAP Study Group. Rehabilitation versus surgical reconstruction for non-acute anterior cruciate ligament injury (ACL SNNAP): a pragmatic randomised controlled trial. Lancet. 2022 Aug 20;400(10352):605-615. doi: 10.1016/S0140-6736(22)01424-6.
PubMed 35988569Davies L, Cook J, Leal J, Areia CM, Shirkey B, Jackson W, Campbell H, Fletcher H, Carr A, Barker K, Lamb SE, Monk P, O'Leary S, Haddad F, Wilson C, Price A, Beard D. Comparison of the clinical and cost effectiveness of two management strategies (rehabilitation versus surgical reconstruction) for non-acute anterior cruciate ligament (ACL) injury: study protocol for the ACL SNNAP randomised controlled trial. Trials. 2020 May 14;21(1):405. doi: 10.1186/s13063-020-04298-y.
PubMed 32410697
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Clinical and Cost Effectiveness of Two Management Strategies for Non-acute Anterior Cruciate Ligament (ACL) Injury: Rehabilitation Versus Surgical Reconstruction.
- ClinicalTrials.gov ID
- NCT02980367
- Acronym / sponsor ID
- ACL SNNAP / 12096
- Conditions
- Anterior Cruciate Ligament Injury
- Keywords
- Anterior Cruciate Ligament, ACL, Anterior Cruciate Ligament deficiency, ACL deficiency, ACLD, Anterior Cruciate Ligament reconstruction, ACL reconstruction, Anterior Cruciate Ligament physiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 2 Dec 2016 (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 primary objective of this study is to determine in patients with non-acute Anterior Cruciate Ligament Deficiency (ACLD) whether a strategy of non-surgical management [Rehabilitation] (with option for later ACL reconstruction, only if required) is more clinically effective and cost effective than a strategy of surgical management [Reconstruction].
Detailed description
The ACL SNNAP study is a pragmatic multi-centre randomised controlled trial with two-arm parallel groups and 1:1 allocation ratio to compare non-surgical management (Rehabilitation) and surgical management (Reconstruction) options for patients with a symptomatic non-acute ACL deficient knee.
The objective is to determine, in patients with non-acute Anterior Cruciate Ligament Deficiency (ACLD), whether non-surgical treatment (with the option for later ACL reconstruction if required) is more effective than surgical ACL reconstruction (as measured by the Knee Injury and Osteoarthritis Outcome Score [KOOS4] at 18 months from randomisation).
Target sample size is 320 patients recruited from approx. 30 NHS orthopaedic units.
An internal pilot will be conducted with clear progression criteria regarding recruitment.
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.
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.
Neither participants nor health care practitioners (surgeons and physiotherapists) can be blinded to receipt of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACL Rehabilitation Group | Experimental | Other: Non-Surgical Management (Rehabilitation)Non-surgical management [Rehabilitation] with option for later Anterior Cruciate Ligament (ACL) reconstruction, only if required. |
| ACL Reconstruction Group | Active comparator | Procedure: Surgical Management (Reconstruction)Surgical Management - Anterior Cruciate Ligament (ACL) reconstruction surgery |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Symptomatic ACL deficiency of the native ligament1 (instability-episodes of frank giving way or feeling unstable) with ACL deficiency (either partial or complete tear) confirmed using clinical assessment and MRI scan.
Key exclusion criteria (7 listed)
- Acute phase of primary ACL injury i.e. not recovered from any acute symptoms relating to their initial ACL injury.
- Previous knee surgery (other than diagnostic arthroscopy or partial meniscectomy) to index knee concomitant severe injury to contra-lateral knee.
- Meniscal pathology with characteristics that indicate immediate surgery i.e. locked knee, large bucket handle or complex cartilage tear producing mechanical symptoms.
- Knee joint status of grade 3 or 4 on the Kellgren and Lawrence scale,
- Grade 3 MCL/LCL injury, associated PCL/PLC injury
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 |
|---|---|---|
| Non-Surgical Management (Rehabilitation)Also: Physical Therapy, Physiotherapy, Conservative Rehabilitation, Conservative ManagementRoutine ACL rehabilitation protocols used at the participating site 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. | Other | ACL Rehabilitation Group |
| Surgical Management (Reconstruction)Also: ACL Reconstruction, ACLR, ACL surgery, Anterior Cruciate Ligament SurgeryAll 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. | Procedure or surgery | ACL Reconstruction Group |
Primary outcome
Knee Injury and Osteoarthritis Outcome Score (KOOS4)
Time frame: 18 months post randomisation
The score is derived from 4 of 5 subscales; pain, symptoms, difficulty in sports and recreational activities, knee related quality of life.
7 secondary outcomes
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: At baseline and at 6, 12 and 18 months post randomisation
Modified Tegner scale
Time frame: At baseline and at 6, 12 and 18 months post randomisation
Intervention related complications
Time frame: At 6, 12 and 18 months post randomisation
EuroQol EQ-5D-5L
Time frame: At baseline and at 6, 12 and 18 months post randomisation
Resource-usage data
Time frame: 18 months post randomisation
Anterior Cruciate Ligament Quality of Life score (ACL-QOL)
Time frame: At baseline and at 6, 12 and 18 months post randomisation
Patient satisfaction
Time frame: At baseline and at 6, 12 and 18 months post randomisation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Derived from this study: PubMed 38940695Beard DJ, Davies L, Cook JA, Stokes J, Leal J, Fletcher H, Abram S, Chegwin K, Greshon A, Jackson W, Bottomley N, Dodd M, Bourke H, Shirkey BA, Paez A, Lamb SE, Barker KL, Phillips M, Brown M, Lythe V, Mirza B, Carr A, Monk P, Areia CM, O'Leary S, Haddad F, Wilson C, Price A; ACL SNNAP Study Group. Comparison of surgical or non-surgical management for non-acute anterior cruciate ligament injury: the ACL SNNAP RCT. Health Technol Assess. 2024 Jun;28(27):1-97. doi: 10.3310/VDKB6009.
- Derived from this study: PubMed 35988569Beard DJ, Davies L, Cook JA, Stokes J, Leal J, Fletcher H, Abram S, Chegwin K, Greshon A, Jackson W, Bottomley N, Dodd M, Bourke H, Shirkey BA, Paez A, Lamb SE, Barker K, Phillips M, Brown M, Lythe V, Mirza B, Carr A, Monk P, Morgado Areia C, O'Leary S, Haddad F, Wilson C, Price A; ACL SNNAP Study Group. Rehabilitation versus surgical reconstruction for non-acute anterior cruciate ligament injury (ACL SNNAP): a pragmatic randomised controlled trial. Lancet. 2022 Aug 20;400(10352):605-615. doi: 10.1016/S0140-6736(22)01424-6.
- Derived from this study: PubMed 32410697Davies L, Cook J, Leal J, Areia CM, Shirkey B, Jackson W, Campbell H, Fletcher H, Carr A, Barker K, Lamb SE, Monk P, O'Leary S, Haddad F, Wilson C, Price A, Beard D. Comparison of the clinical and cost effectiveness of two management strategies (rehabilitation versus surgical reconstruction) for non-acute anterior cruciate ligament (ACL) injury: study protocol for the ACL SNNAP randomised controlled trial. Trials. 2020 May 14;21(1):405. doi: 10.1186/s13063-020-04298-y.
- Individual participant dataSharing planned: Undecided
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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.
David Beard, DPhil principal investigator
University of Oxford
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Surgical Management (Rehabilitation) and Surgical Management (Reconstruction) in people with Anterior Cruciate Ligament Injury, run by University of Oxford at 32 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 7 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 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 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?
Contact David Beard (01865 737210, ACL_SNNAP@ndorms.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Injury and Osteoarthritis Outcome Score (KOOS4) (time frame: 18 months post randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02980367, which also lists 3 linked publications.
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 15 Oct 2021.