Complications
and Adverse Events of a Randomized Clinical Trial Comparing 3 Graft Types for
ACL Reconstruction

Mohtadi N, Barber R, Chan
D, and Paolucci EO. Clin J Sports Med.
2015. [Epub Ahead of Print].

Take
Home Message: Of 330 patients who underwent an anterior cruciate ligament (ACL)
reconstruction surgery, 27% reported an adverse event due to surgery within 2
years but only 2  adverse events (0.6%) were
considered major complications and 24 (7%) required a repeat surgery. This
suggests that overall, ACL reconstruction surgery is generally safe and the
adverse events which do occur can be treated relatively successfully.

We often focus on the short-term
benefits of an anterior cruciate ligament (ACL) reconstruction or the long-term
outcomes of ACL reconstruction but we know very little about the adverse events
(complications) within the first 2 years after surgery. By better understanding
this, clinicians will be better equipped to counsel patients and explore
strategies to prevent these adverse events. Therefore, Mohtadi
and colleagues completed a prospective, double-blind randomized clinical
trial and identified and reported all adverse events following ACL
reconstruction using 3 different grafts.
A post about the primary results of this clinical trial is available on Sports Med Res. A
total of 330 patients (183 males, 29 mean years of age) were randomly assigned
to a patellar-tendon, quadruple-stranded hamstring tendon, or double-bundle
hamstring tendon group. Following ACL reconstruction all patients completed
similar rehabilitation protocols and were contacted at 2 weeks, 3 and 6 months,
and 1 and 2 years post-surgery. Researchers contacted patients by phone and
asked about any adverse events. If an adverse event was reported, the patient came
in to see one of the research team members. Overall, 88 patients (27%) reported
100 adverse events: 24%, 32%and 44% in patellar-tendon, quadruple-stranded
hamstring tendon, or double bundle hamstring tendon groups, respectively. Twenty-four
patients (7%) required an additional surgery (6 to 8% in each group). Hamstring
injury, meniscal tear, persistent effusion, and arthrofibrosis were the most
common adverse events. Among the surgeries, 12 (4%) were performed for a
meniscal tear and 9 (3%) were for intra-articular scarring. Only 12 patients (4%)
reported more than 1 adverse event. Graft type did not influence the number of
adverse events. Two major complications (pulmonary embolism and septic
arthritis) were reported and were resolved with emergency care.

Ultimately, the data presented shows 2
primary points. Firstly, ACL reconstruction surgery should be considered
relatively safe as major complications (2 patients [0.6%]) were uncommon.
Further, no significant difference was found between graft types; however, it should
be noted that information regarding surgeon experience was unclear, making it
difficult to understand if an interaction exists between surgeon experience and
graft type selection. While 100 adverse events were reported, these were
relatively common, treatable events following ACL reconstruction including
hamstring injury, meniscal tear, persistent effusion, and arthrofibrosis.
Secondly, while not very common, 7% of patients required additional procedures
to address their adverse events. This is important for clinicians to
communicate to their patients both before and after reconstruction. While the
incidence was low, if clinicians can communicate this possibility to the
patient, perhaps patients can better understand, anticipate, and rebound from
needing additional procedures. Ultimately, the current study serves to alert clinicians
to the possible adverse events their patient may encounter during the recovery
process from ACL reconstruction surgery. By counseling and communicating these
possibilities perhaps our patients can be better prepared to meet and overcome
the challenges of recovering from a surgery such as this.

Questions for Discussion: Do you counsel your ACL rupture
patients on the potential complications of ACL reconstruction surgery? When and
how do you approach this subject?

Written by: Kyle Harris
Reviewed by:  Jeffrey Driban

Related Posts:

Mohtadi, N., Barber, R., Chan, D., & Paolucci, E. (2015). Complications and Adverse Events of a Randomized Clinical Trial Comparing 3 Graft Types for ACL Reconstruction Clinical Journal of Sport Medicine DOI: 10.1097/JSM.0000000000000202