Summary

In the Stability Study, worsening severity of adverse events were associated with lower patient reported outcome measures at 2 years post-operative following anterior cruciate ligament reconstruction with or without lateral extra-articular tenodesis augmentation.

Abstract

Background

The results of the Stability Study suggest that the addition of lateral extra-articular tenodesis (LET) to a hamstring tendon autograft reduces the rate of anterior cruciate ligament reconstruction (ACLR) failure in high-risk patients. However, there was a higher proportion of patients who experienced hardware irritation and removal following ACLR + LET. It is unclear whether these and other adverse events are similarly associated with changes in patient reported outcome measures (PROMs) and how this should be accounted for in the surgical decision making process.

Objective

Investigate how the severity of adverse events encountered during the follow up period of the Stability Study were associated with patient reported outcomes at two years post-operative.

Methods

Stability is a pragmatic, multicenter, randomized clinical trial comparing single-bundle hamstring tendon ACLR with combined ACLR + LET. Patients aged 14-25 years with an ACL deficient knee were included (n=618). Participants completed PROMs (KOOS, IKDC, ACL-QOL), and adverse events were documented pre-operatively and at 3, 6, 12 and 24 months postoperatively. Adverse events were categorized into four groups: none (no adverse event), minor medical (resolved spontaneously or with minimum medical management), minor surgical (event such as meniscus tear or stiffness that required surgical intervention but is not a graft rupture), contralateral ACL rupture, and graft rupture. A generalized linear model was used to compare mean PROM scores with the different levels of adverse events.

Results

The rate of minor medical adverse events (11.2%), minor surgical adverse events (7.4%), and ipsilateral (7%) or contralateral (3%) ACL tears at 24 months post-operative were low considering the high-risk patient profile. There was no difference in the proportion of minor medical events, minor surgical events, or contralateral ACL ruptures between the ACLR only and ACLR + LET groups (p>0.05). The ACLR only group had a significantly higher rate of graft rupture (11 vs 4%, p<0.01). Increasing severity of adverse events were associated with lower PROM scores at 24 months post-operative. Patients who experienced any adverse event within the two-year follow up had significantly lower outcome scores than those with no events. When only adverse events in the first year post-operative were included, the influence of minor medical and minor surgical events was largely washed out suggesting the effect on outcomes may be due to recency rather than severity. However, graft tears and contralateral ACL tears within the first year led to significantly lower scores at two-years post-operative in all outcomes (p<0.01).

Conclusions

Increasing severity of adverse events were associated with lower patient reported outcome measures at 2 years post-operative. Recent minor medical and minor surgical events worsened PROM scores, but this effect was largely eliminated within a year of the event. Patients who experience a graft rupture or contralateral ACL tear appear to have a significantly lower PROMs at 2 years post-operative, regardless of the time at which the tear occurs. Therefore, the benefit of the LET procedure reducing graft rupture outweighs the potential for less severe events such as hardware irritation/removal which will likely be less detrimental to patient-important outcomes.