Clinical trial NCT06885372: Long-term Follow up of the Stability 1 Trial
Official title: Long-term Follow up of the Stability 1 Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: LET
ACL Reconstruction
Osteoarthritis (OA) of the Knee
Keywords: ACL
ACL injuries
ACL reconstruction
LET
Osteoarthritis
Knee osteoarthritis
Orthopaedics
Anterolateral ligament
Lateral Extra-articular Tenodesis (LET)
Lead sponsor: Western University, Canada
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2025-03-20
Enrollment: 510
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: DIAGNOSTIC

Brief summary: From 2014-2017, across 7 Canadian and 2 European sites, we randomized 618 patients at high-risk of re-injury, to anterior cruciate ligament reconstruction (ACLR) with or without a lateral extraarticular tenodesis (LET) and demonstrated that the addition of the LET reduced the risk of instability (RRR=0.38; 95% Confidence Interval (CI), 0.21-0.52; P=0.0001) and graft re-rupture (RRR, 0.67; 95% CI, 0.36-0.83; P=0.001). As a result, practice has changed; there has been a large increase in the proportion of orthopaedic surgeons recommending the addition of an LET at the time of ACLR and an increase in the number of patients requesting an LET from their surgeon. There is some weak evidence suggesting that in the longer term, the LET may increase the risk of developing osteoarthritis (OA) in that knee. Knee OA affects over 4.4 million Canadians and the number of younger adults being diagnosed with knee OA is growing and is a primary reason for seeking healthcare in Canada. The impact of OA in Canada is enormous and projected to cost Canada $17.5 billion annually in lost productivity alone by 2031. This study will use imaging and patient-reported Knee Outcomes Osteoarthritis Score (KOOS) to evaluate the incidence of OA at 10-years post ACL reconstruction with and without LET. We will also collect information about overall knee health, patient-reported outcomes, costs associated with knee injury, rehabilitation and disability, clinical failure, functional ability, and sport participation. It is crucial that we understand the risks of developing knee OA associated with the addition of an LET to an ACLR so that surgeons and patients can make informed decisions, not just for their immediate post injury treatment of the failed ligament, but for the potential long-term consequences of that decision.


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: Lateral compartment knee OA
timeFrame: 10 Years
measure: Region-specific quality of life using the Knee Osteoarthritis and outcomes Score (KOOS)
timeFrame: 10 Years
Secondary outcomes:
measure: Disease-specific quality of life using the ACL Quality of Life Questionnaire (ACL-QOL)
timeFrame: 10 Years
measure: The Marx Activity Rating Scale (MARS)
timeFrame: 10 Years
measure: Subjective symptoms, function and activity (IKDC)
timeFrame: 10 Years
measure: MRI
timeFrame: 10 Years
measure: Patient Reported Quality of Life (ACL QOL)
timeFrame: 10 Years
measure: 4-Item Pain Intensity Measure (P4)
timeFrame: 10 Years
measure: Clinical Failure
timeFrame: 10 Years
measure: Objective Functional Measures
timeFrame: 10 Years
measure: Adverse Events
timeFrame: 10 Years
Other outcomes:
Locations:
city: Banff
country: Canada
facility: Banff Sport Medicine Clinic
state: Alberta
city: Calgary
country: Canada
facility: University of Calgary
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: Queens 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:
References: