The ACL SNNAP Trial: ACL surgery necessity in non acute patients

Conditions

Specialty: Musculoskeletal disorders, Primary sub-specialty: Elective orthopaedic surgery

David Beard, Loretta Davies, Jonathan Cook, Jamie Stokes, José Leal et al. (28 authors)

Health Technology Assessment2024-06-011 citations

Rehabilitation versus surgical reconstruction for non-acute anterior cruciate ligament injury (ACL SNNAP): a pragmatic randomised controlled trial.

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 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.

2022-08-0166 citations

10.1016/s0140-6736(22)01424-6

ACL Surgery Necessity in Non-Acute Patients (ACL SNNAP): a statistical analysis plan for a randomised controlled trial.

Stokes JR, Beard DJ, Davies L, Shirkey BA, Price A, Cook JA, ACL SNNAP Study Group.

2022-05-124 citations

10.1186/s13063-022-06309-6

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

England, United Kingdom, Wales

Contacts

Public ContactLoretta Davis

loretta.davies@ndorms.ox.ac.uk+44 (0)1865 737210

Outcome results

None listed