Clinical trial NCT02018354: Standard ACL Reconstruction vs ACL + Lateral Extra-Articular Tenodesis Study
Official title: Multicenter Randomized Clinical Trial Comparing Anterior Cruciate Ligament Reconstruction With and Without Lateral Extra-articular Tenodesis in Individuals Who Are At High Risk of Graft Failure.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Reconstruction
Keywords: Orthopaedics
Anterior cruciate ligament (ACL) reconstruction
Anterolateral ligament
Lateral Extra-articular Tenodesis (LET)
Lead sponsor: Western University, Canada
Sponsor class: OTHER
Collaborators: name: International Society of Arthroscopy Knee Surgery and Orthopedic Sports Medicine
First posted: 2013-12-23
Enrollment: 624
Sex: ALL
Minimum age (years): 14
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare outcomes (failure, function, strength, range of motion and quality of life) between patients who receive the usual anterior cruciate ligament (ACL) reconstructive surgery and patients who receive anterior cruciate ligament reconstructive surgery with a lateral extra-articular tenodesis (extra tendon repair on the outside of the knee). Some studies have shown high graft failure rates (ACL re-tear) in young individuals who return to pivoting contact sports following ACL reconstruction. This study is designed to look at whether or not adding this extra tendon repair reduces the risk of graft failure in this population.

Detailed description: This study is a pragmatic study for a parallel groups, randomized clinical trial in which 600 patients with anterior cruciate ligament insufficiency who are undergoing surgery, are randomly allocated to either ACL reconstruction alone (control) or ACL reconstruction with lateral extra-articular tenodesis (experimental). Surgeons, data collectors, and the data analyst will be blind to group allocation. The primary outcome is rate of failure. Secondary outcomes include disease specific quality of life, return to function and sport. Patients are followed for two years postoperative.

Eligibility criteria: Inclusion criteria:

* ACL deficient knee
* skeletally mature to 25 years of age
* 2 or more of:

  * competitive pivoting sport
  * grade 2 pivot shift or greater
  * generalized ligament laxity - Beighton score of 4 or greater

Exclusion criteria:

* previous ACL reconstruction on either knee
* multi-ligament injury (two or more ligaments requiring surgical attention)
* symptomatic articular cartilage defect requiring treatment other than debridement
* greater than 3 degrees of asymmetric varus
* unable to complete outcome questionnaires

Primary outcomes:
measure: Graft Failure
timeFrame: 24 months
Secondary outcomes:
measure: Disease-specific quality of life using the ACL Quality of Life Questionnaire (ACL-QOL)
timeFrame: Baseline, 3, 6, 12, 24 months
measure: Region-specific quality of life using the Knee Osteoarthritis and outcomes Score (KOOS).
timeFrame: Baseline, 3, 6, 12, 24 months
measure: MARX Activity Rating Scale
timeFrame: Baseline, 3, 6, 12, 24 months
measure: Passive knee extension and active-assisted knee flexion
timeFrame: Baseline, 3, 6, 12, 24 months
measure: Quality-adjusted life years (QALYs) using the European Quality of Life Scale (Euro-QoL)
timeFrame: Baseline, 3, 6, 12, 24 months
measure: Radiographic evidence of osteoarthritis
timeFrame: Baseline, 12, 24 months
measure: Subjective symptoms, function and activity.
timeFrame: Baseline, 3, 6, 12, 24 months
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Antwerp Orthopedic Center
city: Banff
country: Canada
facility: Banff Sport Medicine Clinic
state: Alberta
city: New Westminster
country: Canada
facility: Fraser Health Authority
state: British Columbia
city: Winnipeg
country: Canada
facility: Pan Am Clinic
state: Manitoba
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Kingston
country: Canada
facility: Queen's University
state: Ontario
city: London
country: Canada
facility: Fowler Kennedy Sport Medicine Clinic
state: Ontario
city: Coventry
country: United Kingdom
facility: University Hospitals Coventry and Warwickshire NHS Trust
Study officials:
affiliation: University of Western Ontario, Canada
name: Alan Getgood, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Western Ontario, Canada
name: Dianne Bryant, Phd
role: STUDY_DIRECTOR
References:
citation: Marmura H, Getgood AMJ, Spindler KP, Kattan MW, Briskin I, Bryant DM. Validation of a Risk Calculator to Personalize Graft Choice and Reduce Rupture Rates for Anterior Cruciate Ligament Reconstruction. Am J Sports Med. 2021 Jun;49(7):1777-1785. doi: 10.1177/03635465211010798. Epub 2021 May 4.
citation: Getgood AMJ, Bryant DM, Litchfield R, Heard M, McCormack RG, Rezansoff A, Peterson D, Bardana D, MacDonald PB, Verdonk PCM, Spalding T; STABILITY Study Group; Willits K, Birmingham T, Hewison C, Wanlin S, Firth A, Pinto R, Martindale A, O'Neill L, Jennings M, Daniluk M, Boyer D, Zomar M, Moon K, Pritchett R, Payne K, Fan B, Mohan B, Buchko GM, Hiemstra LA, Kerslake S, Tynedal J, Stranges G, Mcrae S, Gullett L, Brown H, Legary A, Longo A, Christian M, Ferguson C, Mohtadi N, Barber R, Chan D, Campbell C, Garven A, Pulsifer K, Mayer M, Simunovic N, Duong A, Robinson D, Levy D, Skelly M, Shanmugaraj A, Howells F, Tough M, Spalding T, Thompson P, Metcalfe A, Asplin L, Dube A, Clarkson L, Brown J, Bolsover A, Bradshaw C, Belgrove L, Millan F, Turner S, Verdugo S, Lowe J, Dunne D, McGowan K, Suddens CM, Declercq G, Vuylsteke K, Van Haver M. Lateral Extra-articular Tenodesis Reduces Failure of Hamstring Tendon Autograft Anterior Cruciate Ligament Reconstruction: 2-Year Outcomes From the STABILITY Study Randomized Clinical Trial. Am J Sports Med. 2020 Feb;48(2):285-297. doi: 10.1177/0363546519896333. Epub 2020 Jan 15.
citation: Getgood A, Bryant D, Firth A; Stability Group. The Stability study: a protocol for a multicenter randomized clinical trial comparing anterior cruciate ligament reconstruction with and without Lateral Extra-articular Tenodesis in individuals who are at high risk of graft failure. BMC Musculoskelet Disord. 2019 May 15;20(1):216. doi: 10.1186/s12891-019-2589-x.