Abstract
Objectives:
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.