Long-term knee arthritis follow-up after ACL surgery with or without an extra tendon procedure

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for young people with a torn ACL (a main knee ligament) at high risk of re-injury. It follows them long term after ACL surgery with or without an added LET procedure, to check for knee arthritis.

Age

14 Years to 25 Years (bones fully grown, up to 25 years of age)

Sex

All

Disease stage

Knee without a working ACL, plus 2 or more of: competitive pivoting sport, grade 2 pivot shift or greater, or loose joints overall (Beighton score of 4 or greater).

Earlier treatment

No previous ACL reconstruction on either knee.

Main reasons for not taking part

• Previous ACL reconstruction on either knee
• Injury to two or more ligaments that need surgery
• Painful cartilage damage needing treatment other than debridement (cleaning out)
• More than 3 degrees of uneven bow-legged alignment (asymmetric varus)
• Unable to complete outcome questionnaires

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 14 and 25 years old?YesNo

What the trial wants to find out

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.

The 2 groups in the trial

• ACL ReconstructionExisting treatment, for comparison

  Standard ACL reconstruction only.

• ACL + LETTreatment being tested

  Anatomic ACL reconstruction following the same procedure as the active comparator group with an added lateral extra-articular tenodesis (LET).

  Treatment: Lateral Extra-Articular Tenodesis (LET) and ACL Reconstruction