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Journal Pre-Proof: Arthroscopy: The Journal of Arthroscopic and Related Surgery
Journal Pre-Proof: Arthroscopy: The Journal of Arthroscopic and Related Surgery
Journal Pre-Proof: Arthroscopy: The Journal of Arthroscopic and Related Surgery
Alex Rezansoff, MD, FRCSC, Andrew D. Firth, MSc, PhD, Dianne M. Bryant, MSc,
PhD, Robert Litchfield, MD, FRCSC, Robert G. McCormack, MD, FRCSC, Mark
Heard, MD, FRCSC, Peter B. MacDonald, MD, FRCSC, Tim Spalding, FRCS,
Peter C.M. Verdonk, MD, PhD, Devin Peterson, MD, FRCSC, Davide Bardana, MD,
FRCSC, STABILITY Study Group, Alan M.J. Getgood, MD, FRCS(Tr&Orth)
PII: S0749-8063(23)00422-X
DOI: https://doi.org/10.1016/j.arthro.2023.05.019
Reference: YJARS 58536
Please cite this article as: Rezansoff A, Firth AD, Bryant DM, Litchfield R, McCormack RG, Heard M,
MacDonald PB, Spalding T, Verdonk PCM, Peterson D, Bardana D, STABILITY Study Group, Getgood
AMJ, Anterior Cruciate Ligament Reconstruction Plus Lateral Extra-articular Tenodesis Has a Similar
Return to Sports Rate as ACLR Alone, But Lower Failure Rate, Arthroscopy: The Journal of Arthroscopic
and Related Surgery (2023), doi: https://doi.org/10.1016/j.arthro.2023.05.019.
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*Alex Rezansoff,16, MD, FRCSC; *Andrew D. Firth17, MSc, PhD; Dianne M. Bryant1,2,3, MSc,
PhD; Robert Litchfield1,2, MD, FRCSC; Robert G McCormack4,5, MD, FRCSC; Mark Heard6,7,
MD, FRCSC; Peter B. MacDonald8,9, MD, FRCSC; Tim Spalding10, FRCS; Peter C.M.
Verdonk11,12, MD, PhD; Devin Peterson13, MD, FRCSC; Davide Bardana14, MD, FRCSC;
STABILITY Study Group, Alan M.J. Getgood1,2, MD, FRCS(Tr&Orth).
*Co-first authors
1Fowler Kennedy Sport Medicine Clinic; 2Department of Surgery, Schulich School of Medicine
and Dentistry, Western University; 3School of Physical Therapy, Western University; 4Department
of Orthopedics, University of British Columbia; 4New West Orthopaedic & Sports Medicine
Centre; 6Deparment of Surgery, University of Calgary; 7Banff Sport Medicine; 8Department of
Surgery, University of Manitoba; 9Pan Am Clinic; 10University Hospital Coventry and
Warwickshire NHS Trust; 11Department of Physical Medicine and Orthopedics, Ghent University;
12Antwerp Orthopedic Center; 13Department of Surgery, McMaster University; 14Department of
Surgery, Queen’s University; 15Department of Surgery, University of Calgary; 16University of
Calgary Sport Medicine Centre, 17Health and Rehabilitation Sciences, Faculty of Health Sciences,
Western University.
Corresponding Author:
Dr. Alan Getgood
Fowler Kennedy Sport Medicine Clinic
3M Building, Western University
London, ON, Canada
agetgoo@uwo.ca
The Stability Study was funded by a research award from the International Society for
Arthroscopic Knee Surgery and Orthopaedic Sports Medicine (ISAKOS).
4 Purpose: To determine whether the addition of an LET to ACLR would improve return to sport rates in
6 Methods: This multicenter, RCT compared standard hamstring tendon ACLR with combined ACLR and LET,
7 utilizing a strip of iliotibial band (Modified Lemaire). Patients aged 25 years or less with an ACL deficient
8 knee were included. They also had to have two of the following criteria: 1) Grade 2 pivot shift or greater; 2)
9 Participation in a high risk/pivoting sport; 3) Generalized ligamentous laxity. Time to return and level of return
11 Results: We randomized 618 patients and 553 played high-risk sports preoperative. The proportion of patients
12 who did not RTS was similar between the ACLR (11%) and ACLR + LET (14%) groups however, graft rupture
13 rate was significantly different (ACLR = 11.2%, ACLR + LET = 4.1%, p = 0.004). Lack of confidence and fear
14 of re-injury was the most cited reason for no RTS. A stable knee was associated with nearly two times greater
15 odds of return to high-level high-risk sport postoperative (OR = 1.92, 95%CI: 1.11 to 3.35, p = 0.02). There were
16 no significant differences in patient-reported functional outcomes or the hop test between groups (p>0.05).
17 Patients who returned to high-risk sport had better hamstring symmetry than those who did not RTS (p = 0.001).
18
19 Conclusions: At 24-months postoperative, patients who underwent ACLR + LET had a similar RTS rate as
20 those who underwent ACLR alone. While the subgroup analysis did not show a statistically significant
21 increase in RTS with the addition of LET, on returning, the addition of LET kept subjects playing longer by
24
25 INTRODUCTION
26 Contemporary single bundle anterior cruciate ligament reconstruction (ACLR) techniques have been shown to
27 perform well subjectively. However, re-injury rates of up to 23% have been reported in patients under 25 years
28 of age.1, 2 Furthermore, return to pre-injury sport rates following ACL reconstruction have been reported to be
30 Based upon the renewed interest in anterolateral reconstruction to improve knee stability, we performed a
31 randomized clinical trial comparing traditional single bundle hamstring ACLR to ACLR augmented with lateral
32 extra-articular tenodesis (LET) in patients less than 25 years of age with a desire to return to sport (STABILITY
33 study).6 The two year outcomes from this study demonstrated that the addition of a LET to a traditional hamstring
34 autograft ACLR leads to a statistically and clinically significant decrease in the clinical failure rates (persistent
35 asymmetric rotatory laxity and graft rupture) from 40% to 25% and graft rupture rates from 11% to 4%.
36 Currently, there is a lack of sufficiently powered and methodologically rigorous randomized trials that have
37 examined whether ACLR with LET has an effect on return to sport in young patients who are considered to be
39 The purpose of this study was to determine whether the addition of an LET to ACLR would improve return to
40 sport rates in young, active patients who play high-risk sports. The hypothesis was that by improving rotatory
41 stability of ACLR by augmenting with an LET, we would observe an improvement in rates of return to sport compared
43 METHODS
44 Study Design and Participants: This study was a pragmatic, parallel groups, multicenter randomized clinical
45 trial in which young patients with ACL deficiency were randomly allocated to either ACLR alone or ACLR with
46 LET. Seven study centers in Canada and two centers in Europe actively recruited patients. The study was
47 approved by Western University’s Research Ethics Board and local Research Ethics Boards at each institution
48 and was registered on Clinical Trials.gov (NCT02018354). A full study protocol has previously been published.8
49
50 Briefly, patients were approached for participation if they were aged between 15-25 years, had an ACL deficient
51 knee, and were at a high risk for re-injury. High risk for re-injury was defined as the presence of two or more of the
52 following: 1) a participant in a competitive pivoting sport;9,5 2) presence of a grade 2 pivot shift or greater; 3)
53 generalized ligament laxity (Beighton score of 4 or greater) or genu recurvatum greater than 10 degrees. 10
54 Patients were ineligible if any of the following were present, 1) previous ACLR on either knee; 2) multi-ligament
55 injury (two or more ligaments requiring surgical attention); 3) a symptomatic articular cartilage defect requiring
56 treatment other than debridement; 4) greater than 3 degrees of asymmetric varus; and 5) unable or unwilling to
58
59 Upon determining eligibility, and willingness to participate, patients were randomized in a 1:1 ratio to either
60 ACLR alone or ACLR with LET. Computer randomization was performed at the time of surgery following
61 arthroscopy to confirm eligibility. Randomization was stratified by surgeon, sex, and presence or absence of
62 meniscus repair requiring more conservative rehabilitation, in permuted block sizes of two and four to ensure
63 that any difference in outcome attributable to these factors was balanced between groups.
64
65 Study Treatments: All patients underwent an anatomic hamstring autograft ACLR performed in a standardized
66 fashion across sites. For patients randomized to receive LET, surgeons utilized a modified Lemaire technique.12
67 Detailed information on the surgical techniques used in the Stability 1 Study has previously been published.8
68
69 All patients, regardless of group allocation, received preoperative and postoperative verbal and written
70 standardized instructions for rehabilitation, focusing upon early range of motion and weight bearing as tolerated,
71 unless a meniscus repair dictated otherwise. The patient’s physical therapist also received a copy of the
72 standardized protocol. A brace was not routinely used. The full rehabilitation protocol can be found in the
73 appendix.
74
75 Outcome measures: Patients were asked for their pre-injury and postoperative level of sport participation (elite,
76 varsity, competitive, recreational, none) and type of sport (high or low risk). High risk sport was defined as sport that
77 requires cutting and pivoting motions and landing from jumps including but not limited to soccer, basketball, hockey,
78 volleyball, football, and rugby. The most common examples of low-risk sports included swimming and running.
79
80 Postoperatively, patients were given a return to sport questionnaire at 6, 12, and 24 months. For those returning to
81 sport, the questionnaire captured the level of competition. For those returning to the same sport, the level of
82 competition was classified as higher, the same, or lower level. The time it took for the patient to return to sport was
83 also captured. Since prior to injury, most of our participants were athletes participating in a high-risk sport 563/618
84 (91.1%), we focused our analysis on the return to sport for this subgroup.
85
86 Knee stability was assessed using the pivot shift test at each clinical follow-up by an assessor blind to group
87 allocation. Patients were provided a tubigrip sleeve for their operative knee to cover surgical incisions and blind
88 outcome assessors to operative group. This sleeve was worn for the blinded clinical assessment and all functional
89 tests. Graft failure, or an unstable knee, was defined as a pivot shift grade of 2+ at any study visit or a pivot shift
90 grade of 1 at multiple study follow-ups or graft rupture after return to sport.6 Patients who suffered graft rupture
92
93 Additionally, functional outcomes including quadriceps peak torque, hamstrings peak torque, the single-leg hop
94 test, the Lower Extremity Functional Scale (LEFS), and the 4-Item Pain Intensity Measure (P4) were collected
95 at 6-, 12-, and 24-months postoperative. These outcomes have been reported in detail in previous publications.8,
96 13
97
98 Sample size and statistical analysis: This study is an analysis of secondary outcomes from the Stability 1 study. A
99 priori sample size was calculated for the full trial using the primary outcome of graft failure, and a minimum of 600
100 patients (300 per group) were required.8 In this sub-group analysis, each treatment group was split into four sub-groups
101 based on the level of sport achieved within two years postoperative, for a total of eight groups. For 13 patients who
102 were missing data on their RTS questionnaire, we were able to impute their sport and level of competition using data
103 from their ACL-QOL and Marx questionnaire to include them in the analysis.
104
105 For this paper, we excluded patients who preoperatively participated in low-risk sports or no sports. To explore the
106 prognostic factors between the original STABILITY 1 cohort and those participants included in this analysis, we used
107 mean and standard deviation for continuous variables and proportions for dichotomous variables. Patients were
108 categorized into 4 groups: those who participated in a high-risk sport preoperatively who returned to: 1) a high-risk
109 high-level sport (HR to HRHL); 2) a high risk, recreational sport (HR to HRLL); 3) a low-risk sport at any level (HR
110 to LR), or 4) did not return to sport (HR to no RTS). We recorded the reasons for not returning to sport for all
111 participants who participated in sport prior to injury, regardless of level of preoperative sport participation. Small
112 numbers of patients in some subgroups limited our ability to perform statistical analyses with precision. In particular,
113 few patients participating in a high-risk sport preoperatively had LSI data (n=19) or strength data (n=25) and did not
115
116 We used Mann-Whitney U to perform between group comparisons within the categories of postoperative level of
117 sport participation. We planned to look at the relationship between the proportion of patients with a stable knee and
118 postoperative return to sport level and class. A stable knee was defined using the study criteria.8 We ran this analysis
119 using the entire cohort, then stratified the analysis by ACLR Alone and ACLR + LET. Logistic regression was used
120 to determine the relationship between knee stability and postoperative return to sport level. The odds of returning to
121 each level of sport with a stable knee compared to an unstable knee and associated 95% confidence intervals were
122 presented graphically for each level. Patients who returned to sport prior to graft rupture were included in this analysis,
123 and they were defined according to their laxity status at visits prior to their graft rupture.
124
125 For this analysis, we used the strength, LSI, LEFS and P4 measured at 24 months postoperatively unless the
126 patient suffered a graft failure or contralateral ACL rupture; for these patients the measurement taken prior to
127 the injury was used in the analysis. We used boxplots to visualize these outcomes by subgroup, then performed a
128 Mann-Whitney U test to compare medians and distributions between groups at each level of postoperative RTS.
130
131 RESULTS
132
133 Subject Characteristics: Enrollment of patients occurred between January 2014 and March 2017. Of the 1033
134 patients screened for eligibility, 358 were ineligible, 48 were eligible but non-consenting, and 9 were consented
135 but did not undergo surgery. Thus, 618 patients were randomized in the STABILITY 1 Study (Figure 1).
136
137 We excluded 65 patients from this analysis, including 58 patients who did not participate in high-risk sport pre-
138 operatively and 7 patients who were LTF early without providing data on RTS, which left 553 patients available
139 for analysis (ACLR = 285, ACLR+LET = 268). Final follow-up occurred at an average of 24.6 months (SD =
140 1.7) and 24.7-months (SD = 1.8) for the ACLR and ACLR+LET groups, respectively (range: 20.7 to 32.8).
141 PROMs were available for 476 of those patients (ACLR = 247, ACLR+LET = 239). Two centers collected
142 strength data (78 ACLR, 80 ACLR+LET) and two centers collected hop test data (118 ACLR, 109 ACLR+LET).
143 There were no differences between the STABILITY 1 cohort and the participants retained for this analysis for
145
146 The mean participant age was 18.8 years (range, 14-25 years), with just over 75% (418/533) returning to pivoting
147 sports postoperatively, representing a cohort of patients at high risk of ACLR failure.
148
149 Return to Sport: There was no significant difference between patients randomized to ACLR or to ACLR+LET in their
150 pre-injury level of sport participation (Table 2). Of the 618 patients in the study, information on RTS was available for
151 603 (97.8%). There was no significant difference between groups in the postoperative type (high v low risk) and level
152 of sport (Table 2). From the STABILITY 1 cohort, the proportion of patients who did not return to sport was not
153 statistically different between groups (ACLR 11%, ACLR + LET 15%, p = 0.08) (Table 2). Within the subgroup of
154 patients that played high-risk sport pre-operatively, 285 patients in the ACLR group and 268 patients in the ACLR +
155 LET reported on their return to sport activities. Seventy-six patients who played high-risk sport prior to ACL rupture
156 did not return to sport postoperatively (34 (12%) ACLR, 42 (16%) ACLR+LET, p = 0.20).
157
158 Reasons for not returning to sport: Seven patients who did not return to sport suffered an early complication or
159 adverse event; one patient had early infection followed by a graft rupture at 3 months (ACLR), one had excessive
160 stiffness and underwent a manipulation under anesthetic and arthrolysis (ACLR), one had a cyclops lesion requiring
161 debridement (ACLR), two had failed meniscal repairs (1 ACLR, 1 ACLR+LET), and one still complained of
162 hamstring pain at 24 months postoperative (ACLR). Other reasons cited by patients for not returning to sport included
163 losing interest or being too busy, lack of confidence and fear of re-injury, not yet being cleared to play, feeling unfit or
164 not making the team, graduating school/aging out, and being out of season (Table 3). The most common reason for
165 not returning to sport cited for both groups was a lack of confidence and fear of re-injury (ACLR: 15/34 vs ACLR +
167
168 Associations between return to sport level and knee stability: Of the patients who were participating in a high-risk
169 sport prior to injury who either did not return to sport or returned to a low-risk sport postoperatively with available
170 clinical outcomes, 46/122 (37.7%) had a persistent asymmetric pivot shift (28 ACLR, 18 ACLR+LET) without graft
171 rupture (OR=0.60, 95%CI: 0.29 to 1.21, p=0.15). Of those who returned to a high-risk sport, 23.0% (85/370) had a
172 persistent asymmetric pivot shift (48 ACLR, 37 ACLR+LET) without rupture (OR=0.80, 95%CI: 0.50 to 1.30,
173 p=0.37). Unfortunately, 9.3% (43/464) suffered a graft rupture (32 ACLR, 11 ACLR+LET) after returning to sport
175
176 There was a pattern showing a dose response relationship between the proportion of patients with a stable knee and
177 return to increasingly demanding activity postoperatively (Table 4). Having a stable knee was associated with over
178 1.5-times higher odds (OR = 1.92, 95%CI: 1.11 to 3.35, p = 0.02) of successfully returning to HRHL sport compared
179 to those with an unstable knee. The odds of returning to a HRLL sport (OR =1.74, 95%CI: 0.96 to 3.14, p = 0.07) and
180 LR sport were similar to not returning to sport at all with a stable knee compared to a knee with laxity. To test the
181 robustness of this effect we ran an adjusted model that included age and treatment group (ACLR alone or ACLR +
182 LET) in which the significant relationship remained. This analysis is further stratified by treatment group in Table 5
183 demonstrating greater stability for the ACLR + LET group at each level of return to sport compared to the ACLR
185
186 Associations between RTS and performance-based outcomes: Because there were small numbers of participants
187 who participated in only low risk sports prior to ACL rupture, this analysis was limited to those who participated in a
189 Strength: Figure 2 shows the median peak torque for the quadriceps ratio over ordered categories of demand for
190 postoperative sport. The ACLR Alone group had greater symmetry than the ACLR + LET group within those not
191 returning to sport (p=0.005), otherwise no statistically significant differences were found. For the hamstring ratio,
192 patients who returned to a high-risk sport had better symmetry than those who returned to a low-risk sport or who did
193 not return to sport (p=0.001). For the hamstrings to quadriceps ratio (operative side), ratios were similar across demand
194 categories. The only statistically significant difference between groups was in those who did not return to sports
195 (p=0.018).
196
197 Hop Test Limb Symmetry Index: The LSI was similar between groups for all categories of return to sport. The median
198 LSI in each group was 0.95 or higher in each group with the 25th percentile greater than 0.90 for all groups at all levels
199 (Figure 3). Further exploration of each of the four hop tests revealed similar results between groups.
200
201 Patient-reported function and pain: There were no significant differences between groups for patient-reported
203
204 DISCUSSION
205 The most important finding from this study is that the majority of patients who played sports preoperatively were able
206 to return to sport by 2-years postoperative. By breaking down the types of sport to which individuals returned, we
207 were able to better establish the intensity of play and as such have a more complete picture of the risk of re-injury that
208 occurs with return to sport post ACLR. Most of our patient cohort were involved in high-risk sports at the time of
209 their injury. Of those, 76% were able to return to a high-risk sport, with a further 11% returning to a lower risk sport
210 but remaining active. If we include patients playing low risk sports pre-injury who returned to the same level,
211 approximately 87% of our patient cohort were able to return to sport by two years post ACLR. Although there were
212 no significant differences between groups in terms of those patients reaching the higher risk levels of sport, patients
213 who did return to the high-risk high-level sports had a 70% relative risk reduction in graft failure if treated with an
214 additional LET, mirroring what was observed in the full trial that included all patients. This further demonstrates that
215 having a more stable knee is a significant factor in an athletes return to high-risk sports at a high-level of play.
216
217 These findings contrast the systematic review by Ardern et al.3 who demonstrated that only 63% of patients can return
218 to sport following ACLR. This difference may be explained by the eligibility criteria for the STABILITY 1 study that
219 limits the study sample to young, active individuals (< 25 years of age, involved in sports and/or hypermobile), who
220 are more likely to have time/energy/opportunity to return to sport. Our findings are similar to a study by Lai et al.18
221 in which an 83% return to sport rate was observed in a cohort of elite athletes. As such, the results of our study may
222 not be generalizable to the normally distributed ACL injured population. However, the systematic review and meta-
223 analysis by Kay et al.19 also determined that there is a high rate of return to sport in adolescents after ACLR (greater
224 than 90%), indicating that a number of other factors may prevent older patients from returning to sport. In our study,
225 several participants reported either having lost interest in returning to sport, likely due to school or work commitments
226 being too heavy, or that they aged out of being eligible for participation. It is possible that older populations of patients
227 have a greater amount of these sorts of issues due to more demanding work and family life commitments.
228
229 One interesting finding is that patients with greater rotational stability of the knee, whether that was due to the addition
230 of LET or not, had a greater chance of returning to high-risk high-level sport postoperatively. Return to high-risk low-
231 level sports and low-risk sports were not associated with greater stability. While analyzing the cohort together allowed
232 us to detect a pattern of increased knee stability in patients that returned to increasingly demanding levels of sport,
233 there were no differences between ACLR with or without the addition of LET in rates of return to sport by 24 months
234 post-surgery for level of sport and the degree of risk associated with the sport for subsequent ACL rupture. This is
235 likely due to the size of the effect, as even using the full sample size without stratifying by group, the 95%CIs were
236 wide with the lower limit approaching the line of no difference. Relatively few patients did not return to sport or
237 returned to low-risk sport in our study, and the statistical power decreases further when we compare the ratio of stable
238 and unstable patients within these groups. Knee stability is one of many factors that may affect a patients’ decision to
239 return to sports following ACLR, as demonstrated in Table 3, which may also explain why the two groups were similar
240 in terms of return to sport. Our results did show the ACLR+LET group had a slightly higher proportion of patients
241 with a stable knee at each level of return to sport, a potentially interesting finding given the significant difference in
243
244 While our return to sport rate was high, there was still a number of patients who did not return to sport postoperatively,
245 even with a stable knee. Some patients indicated they aged out of sport or were too busy to return (Table 3), which
246 suggests a change in priorities and potential response shift following ACLR. Response shift is a phenomenon proposed
247 to occur following a significant life event which leads to a change in patients priorities.20 This can be problematic
248 when using PROMs to determine the effect of treatment, as items on PROMs are designed under the assumption that
249 patients will interpret them the same way at each visit.21 If patients’ priorities change over time, such as the role or
250 importance of sport in their lives, so too might their interpretation of PROMs that ask questions about sports
251 participation and function.20 The response shift phenomenon could help explain why the STABILITY study was able
252 to demonstrate significant differences in clinical outcomes between the ACLR Alone and ACLR + LET groups6, yet
253 no difference in functional outcomes or quality of life was observed.6, 13 Our sample includes young, active participants
254 who may be transitioning from high school to post-secondary education, or joining the work force, around the time
255 they undergo ACLR. While a portion of patients do not return to their baseline level of sport, they may achieve of
256 level of function and activity that they deem satisfactory as it fits their new lifestyle. Response shift has yet to be
257 established in patients following ACLR and should be studied further, as this phenomenon can greatly affect the ability
259
260 Not surprisingly, the main reason patients reported for not returning to sport in this study was fear of re-injury.
261 Kinesiophobia has been demonstrated in multiple studies to be a significant factor in patients return to play status.23,
24
262 By developing the ACL-RSI scale, Webster et al.25 have observed improved return to sport and reduced re-injury
263 rates in patients with higher levels of confidence. This scale has now been utilized in multiple studies and proves to
265
266 Whilst we did not employ the ACL-RSI, we did look at a number of other postoperative factors to determine readiness
267 of return to play. Isokinetic and isometric quadriceps strength have been used as a simple tool to determine readiness
268 for return to sport.27, 28 A number of studies have shown that quadriceps strength is an important predictor of readiness
269 of return.29-32 A cross-sectional study of 94 patients by Lentz et al. (2012) found that quadriceps peak torque-body
270 weight ratio was an important contributor to their model predicting return to sport at one-year postoperative, though
271 it was not independently statistically significant (p = 0.05).29 A subsequent study of 73 participants by Lentz et al.
272 (2015) found that both quadriceps symmetry (p = 0.009) and quadriceps torque normalized for body weight (p = 0.04)
273 were significantly higher at 6-months in those who had returned to sport compared to those who had not.30 Two studies
274 assessing factors related to psychological readiness to return to sport found that quadriceps strength symmetry was
275 associated with readiness to return to play in both males32 and females, if female patients suffered a non-contact ACL
276 tear rather than a contact injury.31 A similar finding was observed with quadriceps strength in our study, in particular
277 peak quadricep torque. Improvements in peak torque quadriceps ratios were associated with higher levels of return to
278 sport. The ACLR only group had greater symmetry between limbs, presumably due to the quicker quadricep strength
279 recovery compared with the LET group.13 The clinical significance of this is unclear, as there were no differences in
280 return to sport between groups. It is possible that the addition of the LET provided improved knee stability to allow
281 return, while the ACL only group required improved quadriceps strength. However, a clear cause and effect
282 relationship cannot be determined and the relationship between quadriceps strength, RTS, and augmentation of ACLR
283 with LET needs to be explored further. Hamstring strength had no impact on rates of return.
284
285 The lack of significance of the hop test LSI is another important finding from this study. These tests were unable to
286 discern differences between groups or predict the ability to return to sport. This is primarily due to the ceiling effect
287 that was observed with these tests. Most patients were able to achieve at least 90% by the 6-month mark. In our
288 experience, a qualitative assessment of movement pattern is more likely to determine whether patients are ready for
289 return, such as determination of stiff legged landing, trunk lean or lack of balance than the actual numbers recorded.
290 There is also potential for athletes to ‘game the system’, by recording a reduced measurement on the opposite limb,
291 thereby achieving a better LSI. Other studies have also observed that hop test LSI is not that predictive of a successful
293
294 Based on this information, many groups have recommended a batch of return to sport tests to determine readiness and
295 injury reduction risk, rather than utilizing a single modality. Kyritsis et al.34 utilized a battery of six tests including
296 isokinetic strength testing at 60 degrees, 180 degrees and 300 degrees/s, a running t test, single hop, triple hop
297 and triple crossover hop tests. They found that athletes who failed to pass all six tests were at a four times higher
298 risk of ACL re-injury than those who passed.34 In a systematic review by Webster and Hewett36, passing a return
299 to sport battery of tests resulted in a reduction risk of subsequent graft rupture by 60% (RR = 0.40 (95% CI 0.23-
300 0.69), p < 0.001]. However, it also increased the risk for a subsequent contralateral ACL injury (RR = 3.35 (95%
302
303 A retrospective review of 24 professional male soccer players who received ACLR with a LET procedure
304 showed significantly reduced anterior-posterior laxity and the rate of return to pre-injury level of sport was
305 91.7%.37 A similar retrospective study of 16 high-level female soccer players who received ACLR with LET
306 showed all the athletes returned to the same pre-injury level of sport.38 A case series of 52 patients who received
307 ACLR and LET with 22 years of follow-up showed only one patient experienced a graft failure, and there were
308 no significant medial or lateral joint space changes.39 Most recently a systematic review of 19 studies (1,372
309 patients) demonstrated high rates of return to play (82.8% to 100%) when ACLR was augmented with an extra-
310 articular augmentation.40 Of note, two of six studies that compared ACLR alone and ACLR augmented with an
311 extra-articular procedure in patients competing at similar levels, resulted in a higher rate of return to sport with
313 Limitations
314 There are limitations with this study. The degree of game readiness was not assessed at the time the patient did return
315 to sport. This could mean that patients in either group could be returning to their sport prior to being cleared by a
316 medical professional, and prior to being ready to return. The amount of exposure to the specific sport was also not
317 directly measured. It is therefore difficult to determine whether patients returned to full intensity competition for the
318 full duration of games versus practice sessions and returning to game time as a substitute. However, these are factors
319 that are always challenging to measure in studies that analyze return to sport post ACLR. Lastly, this paper involved
320 an exploratory subgroup analysis from a larger trial. Most of our participants played high-risk sports pre- and post-
321 operative, which left us with a small number of participants within each low-risk subgroup. Few observations meant
323
324 Conclusion
325 At 24-months postoperative, patients who underwent ACLR + LET had a similar RTS rate as those who
326 underwent ACLR alone. While the subgroup analysis did not show a statistically significant increase in RTS
327 with the addition of LET, on returning, the addition of LET kept subjects playing longer by reducing graft
329
330 REFERENCES
331 1. Weber AE, Zuke W, Mayer EN, et al. Lateral Augmentation Procedures in Anterior
332 Cruciate Ligament Reconstruction: Anatomic, Biomechanical, Imaging, and Clinical
333 Evidence. Am J Sports Med. 2019;47:740-752.
334 2. Wood R, Marsh J, Getgood A. Anterolateral Complex Reconstruction: Another Fad or
335 Method to Improve ACL Outcomes? Tech Orthop. 2018;33:239-245.
336 3. Ardern CL, Webster KE, Taylor NF, Feller JA. Return to sport following anterior
337 cruciate ligament reconstruction surgery: a systematic review and meta-analysis of
338 the state of play. Br J Sports Med. 2011;45:596-606.
339 4. Ithurburn MP, Longfellow MA, Thomas S, Paterno MV, Schmitt LC. Knee Function,
340 Strength, and Resumption of Preinjury Sports Participation in Young Athletes
341 Following Anterior Cruciate Ligament Reconstruction. J Orthop Sports Phys Ther.
342 2019;49:145-153.
343 5. Muller B, Yabroudi MA, Lynch A, et al. Return to preinjury sports after anterior
344 cruciate ligament reconstruction is predicted by five independent factors. Knee Surg
345 Sports Traumatol Arthrosc. 2022;30:84-92.
346 6. Getgood AMJ, Bryant DM, Litchfield R, et al. Lateral Extra-articular Tenodesis
347 Reduces Failure of Hamstring Tendon Autograft Anterior Cruciate Ligament
348 Reconstruction: 2-Year Outcomes From the STABILITY Study Randomized Clinical
349 Trial. Am J Sports Med. 2020:363546519896333.
350 7. Riediger MD, Stride D, Coke SE, Kurz AZ, Duong A, Ayeni OR. ACL Reconstruction
351 with Augmentation: a Scoping Review. Curr Rev Musculoskelet Med. 2019;12:166-
352 172.
353 8. Getgood A, Bryant D, Firth A, Stability G. The Stability study: a protocol for a
354 multicenter randomized clinical trial comparing anterior cruciate ligament
355 reconstruction with and without Lateral Extra-articular Tenodesis in individuals
356 who are at high risk of graft failure. BMC musculoskeletal disorders. 2019;20:216.
357 9. Borchers JR, Pedroza A, Kaeding C. Activity level and graft type as risk factors for
358 anterior cruciate ligament graft failure: a case-control study. Am J Sports Med.
359 2009;37:2362-2367.
360 10. Group M, Cooper DE, Dunn WR, et al. Physiologic Preoperative Knee Hyperextension
361 Is a Predictor of Failure in an Anterior Cruciate Ligament Revision Cohort: A Report
362 From the MARS Group. Am J Sports Med. 2018;46:2836-2841.
363 11. Magnussen RA, Lawrence JT, West RL, Toth AP, Taylor DC, Garrett WE. Graft size
364 and patient age are predictors of early revision after anterior cruciate ligament
365 reconstruction with hamstring autograft. Arthroscopy. 2012;28:526-531.
366 12. Mathew M, Dhollander A, Getgood A. Anterolateral Ligament Reconstruction or
367 Extra-Articular Tenodesis: Why and When? Clin Sports Med. 2018;37:75-86.
368 13. Getgood A, Hewison C, Bryant D, et al. No Difference in Functional Outcomes When
369 Lateral Extra-Articular Tenodesis Is Added to Anterior Cruciate Ligament
370 Reconstruction in Young Active Patients: The Stability Study. Arthroscopy.
371 2020;36:1690-1701.
372 14. Noyes FR, Barber SD, Mangine RE. Abnormal lower limb symmetry determined by
373 function hop tests after anterior cruciate ligament rupture. Am J Sports Med.
374 1991;19:513-518.
375 15. Reid A, Birmingham TB, Stratford PW, Alcock GK, Giffin JR. Hop testing provides a
376 reliable and valid outcome measure during rehabilitation after anterior cruciate
377 ligament reconstruction. Phys Ther. 2007;87:337-349.
378 16. Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale
379 (LEFS): scale development, measurement properties, and clinical application. North
380 American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999;79:371-
381 383.
382 17. Spadoni GF, Stratford PW, Solomon PE, Wishart LR. The evaluation of change in pain
383 intensity: a comparison of the P4 and single-item numeric pain rating scales. J
384 Orthop Sports Phys Ther. 2004;34:187-193.
385 18. Lai CCH, Ardern CL, Feller JA, Webster KE. Eighty-three per cent of elite athletes
386 return to preinjury sport after anterior cruciate ligament reconstruction: a
387 systematic review with meta-analysis of return to sport rates, graft rupture rates
388 and performance outcomes. Br J Sports Med. 2018;52:128-138.
389 19. Kay J, Memon M, Marx RG, Peterson D, Simunovic N, Ayeni OR. Over 90 % of children
390 and adolescents return to sport after anterior cruciate ligament reconstruction: a
391 systematic review and meta-analysis. Knee Surg Sports Traumatol Arthrosc.
392 2018;26:1019-1036.
393 20. Vanier A, Oort FJ, McClimans L, et al. Response shift in patient-reported outcomes:
394 definition, theory, and a revised model. Qual Life Res. 2021;30:3309-3322.
395 21. Vanier A, Leplège A, Hardouin JB, Sébille V, Falissard B. Semantic primes theory may
396 be helpful in designing questionnaires such as to prevent response shift. J Clin
397 Epidemiol. 2015;68:646-654.
398 22. Ring L, Höfer S, Heuston F, Harris D, O'Boyle CA. Response shift masks the treatment
399 impact on patient reported outcomes (PROs): the example of individual quality of
400 life in edentulous patients. Health Qual Life Outcomes. 2005;3:55.
401 23. Ardern CL, Österberg A, Tagesson S, Gauffin H, Webster KE, Kvist J. The impact of
402 psychological readiness to return to sport and recreational activities after anterior
403 cruciate ligament reconstruction. Br J Sports Med. 2014;48:1613-1619.
404 24. Flanigan DC, Everhart JS, Pedroza A, Smith T, Kaeding CC. Fear of reinjury
405 (kinesiophobia) and persistent knee symptoms are common factors for lack of
406 return to sport after anterior cruciate ligament reconstruction. Arthroscopy.
407 2013;29:1322-1329.
408 25. Webster KE, Feller JA, Lambros C. Development and preliminary validation of a scale
409 to measure the psychological impact of returning to sport following anterior
410 cruciate ligament reconstruction surgery. Phys Ther Sport. 2008;9:9-15.
411 26. McPherson AL, Feller JA, Hewett TE, Webster KE. Smaller Change in Psychological
412 Readiness to Return to Sport Is Associated With Second Anterior Cruciate Ligament
413 Injury Among Younger Patients. Am J Sports Med. 2019;47:1209-1215.
414 27. Schmitt LC, Paterno MV, Hewett TE. The impact of quadriceps femoris strength
415 asymmetry on functional performance at return to sport following anterior cruciate
416 ligament reconstruction. J Orthop Sports Phys Ther. 2012;42:750-759.
417 28. Larsen JB, Farup J, Lind M, Dalgas U. Muscle strength and functional performance is
418 markedly impaired at the recommended time point for sport return after anterior
419 cruciate ligament reconstruction in recreational athletes. Hum Mov Sci. 2015;39:73-
420 87.
421 29. Lentz TA, Zeppieri G, Jr., Tillman SM, et al. Return to preinjury sports participation
422 following anterior cruciate ligament reconstruction: contributions of demographic,
423 knee impairment, and self-report measures. J Orthop Sports Phys Ther. 2012;42:893-
424 901.
425 30. Lentz TA, Zeppieri G, Jr., George SZ, et al. Comparison of physical impairment,
426 functional, and psychosocial measures based on fear of reinjury/lack of confidence
427 and return-to-sport status after ACL reconstruction. Am J Sports Med. 2015;43:345-
428 353.
429 31. Della Villa F, Straub RK, Mandelbaum B, Powers CM. Confidence to Return to Play
430 After Anterior Cruciate Ligament Reconstruction Is Influenced by Quadriceps
431 Strength Symmetry and Injury Mechanism. Sports Health. 2021;13:304-309.
432 32. Straub RK, Della Villa F, Mandelbaum B, Powers CM. Confidence to Return to Play
433 After ACL Reconstruction: An Evaluation of Quadriceps Strength Symmetry and
434 Injury Mechanism in Male Athletes. Sports Health. 2021:19417381211043854.
435 33. Jang SH, Kim JG, Ha JK, Wang BG, Yang SJ. Functional performance tests as indicators
436 of returning to sports after anterior cruciate ligament reconstruction. Knee.
437 2014;21:95-101.
438 34. Kyritsis P, Bahr R, Landreau P, Miladi R, Witvrouw E. Likelihood of ACL graft
439 rupture: not meeting six clinical discharge criteria before return to sport is
440 associated with a four times greater risk of rupture. Br J Sports Med. 2016;50:946-
441 951.
442 35. Grindem H, Snyder-Mackler L, Moksnes H, Engebretsen L, Risberg MA. Simple
443 decision rules can reduce reinjury risk by 84% after ACL reconstruction: the
444 Delaware-Oslo ACL cohort study. Br J Sports Med. 2016;50:804-808.
445 36. Webster KE, Hewett TE. What is the Evidence for and Validity of Return-to-Sport
446 Testing after Anterior Cruciate Ligament Reconstruction Surgery? A Systematic
447 Review and Meta-Analysis. Sports Med. 2019;49:917-929.
448 37. Alessio-Mazzola M, Formica M, Russo A, et al. Outcome after Combined Lateral
449 Extra-articular Tenodesis and Anterior Cruciate Ligament Revision in Professional
450 Soccer Players. J Knee Surg. 2019;32:906-910.
451 38. Guzzini M, Mazza D, Fabbri M, et al. Extra-articular tenodesis combined with an
452 anterior cruciate ligament reconstruction in acute anterior cruciate ligament tear in
453 elite female football players. Int Orthop. 2016;40:2091-2096.
454 39. Zaffagnini S, Marcheggiani Muccioli GM, Grassi A, et al. Over-the-top ACL
455 Reconstruction Plus Extra-articular Lateral Tenodesis With Hamstring Tendon
456 Grafts: Prospective Evaluation With 20-Year Minimum Follow-up. Am J Sports Med.
457 2017;45:3233-3242.
458 40. Hurley ET, Manjunath AK, Strauss EJ, Jazrawi LM, Alaia MJ. Return to Play After
459 Anterior Cruciate Ligament Reconstruction with Extra-Articular Augmentation: A
460 Systematic Review. Arthroscopy. 2021;37:381-387.
461
462 Table 1 - Patient characteristics for the entire STABILITY 1 Study and restricted to the preoperative high-
463 risk sport cohort
High-risk Sport
Stability 1 Cohort
Characteristic Cohort
(n = 618)
(n = 553)
467 Table 3 - Reasons cited for not returning to sport post-surgery provided by participants who were
468 participating in a sport preoperatively
Did not return to any sport (n = 76) ACLR alone (n = 34) ACLR + LET (n = 42)
Why?
Significant re-injury or complication 2 0
Lost interest/Too busy 6 9
Lack of confidence/Fear of re-injury 15 15
Not yet cleared to play 2 0
Decline in physical fitness 6 9
Out of season 1 1
Aged Out/Graduated 4 6
*sums to greater than 100% since patients could give more than one reason; does not include patients who were
not participating in sports preoperatively.
469
470 Table 4 - Proportion of patients with a stable knee by postoperative return to sport level and classification
Level Unstable Stable Proportion
(n = 139) (n =414)
No RTS 27 49 64.5%
Low Risk Sport 22 37 62.7%
High Risk Low Level 39 123 75.9%
High Risk High Level 51 205 80.1%
471
472 Table 5 - Proportion of patients with a stable knee by postoperative return to sport level and
473 classification, stratified by ACLR Alone or ACLR + LET
ACLR Alone ACLR + LET
Level Unstable Stable Proportion Unstable Stable Proportion
(n = 88) (n = 197) (n = 57) (n = 211)
No RTS 14 20 58.8% 13 29 69.0%
Low Risk Sport 15 20 57.1% 7 17 70.8%
High Risk Low Level 26 54 67.5% 13 69 84.1%
High Risk High Level 33 103 75.7% 24 96 80.0%
474
477
478 Figure 2: Strength outcomes for participants who were participating in a high-risk sport preoperatively. Strength
479 was measured after return to sport (RTS) or at 24 months postoperative if the participant had not yet RTS. For those
480 participants who suffered a graft or contralateral ACL rupture, we used the strength measurements closest to the
481 event. The boxplot illustrates the differences in (A) quadriceps ratio (operative to non-operative), (B) hamstrings
482 ratio, and (C) quadriceps to hamstrings ratio (operative side). Each plot illustrates the difference in strength between
483 study groups (ACLR=blue, ACLR+LET=red) when participants return to different sport type (high-risk (HR) versus
484 low-risk (LR)) and sport level (high-level (HL): elite, varsity, competitive versus low-level (LL): recreational). HR =
485 high-risk, LR = low-risk, HL = high-level, LL = low-level.
486
487
488 Figure 3: Limb symmetry Index (LSI) for participants who were participating in a high-risk sport preoperatively.
489 LSI was measured after return to sport (RTS) or at 24 months postoperative if the participant had not yet RTS. For
490 those participants who suffered a graft or contralateral ACL rupture, we used the LSI measure closest to the event.
491 The boxplot illustrates the differences in LSI between study groups when participants return to different sport type
492 (high-risk (HR) versus low-risk (LR)) and sport level (high-level (HL): elite, varsity, competitive versus low-level
493 (LL): recreational). HR = high-risk, LR = low-risk, HL = high-level, LL = low-level.
494
495
496 Figure 4: Patient-reported functional outcomes for participants who were participating in a high-risk sport
497 preoperatively. Questionnaires were completed at the 24-month visit unless the participant suffered a graft or
498 contralateral ACL rupture, in which case we used the score from the previous visit. The boxplot illustrates the
499 differences in median scores for patients returning to increasingly more demanding levels of sport for the A) LEFS
500 and B) P4. HR = high-risk, LR = low-risk, HL = high-level, LL = low-level.
501
A