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Agarwalla 2018
Agarwalla 2018
Background: Anterior cruciate ligament (ACL) tears are one of the most common traumatic knee injuries experienced by athletes.
Return to sport is considered the pinnacle endpoint among patients receiving ACL reconstruction. However, at the time of return
to sport, patients may not be participating at their previous levels of function, as defined by clinical metrics.
Purpose: To establish when patients perceive maximal subjective medical improvement according to patient-reported outcome
measures (PROMs).
Study Design: Systematic review.
Methods: A systematic review of the PubMed database was conducted to identify studies that reported sequential PROMs up to
a minimum of 2 years after ACL reconstruction. Pooled analysis was conducted for PROMs at follow-up points of 3 months, 6
months, 1 year, and 2 years. Clinically significant improvement was determined between pairs of intervals with the minimal clin-
ically important difference.
Results: This review contains 30 studies including 2253 patients who underwent ACL reconstruction. Clinically significant
improvement in the KOOS (Knee injury and Osteoarthritis Outcome Score) was seen up to 1 year after ACL reconstruction,
but no clinical significance was noted from 1 to 2 years. Clinically significant improvement in the IKDC (International Knee Doc-
umentation Committee) and Lysholm questionnaires was seen up to 6 months postoperatively, but no clinical significance was
noted beyond that.
Conclusion: After ACL reconstruction, maximal subjective medical improvement is established 1 year postoperatively, with no
further perceived clinical improvement beyond this time point according to current PROMs. The KOOS may be a more responsive
metric to subjective improvements in this patient cohort than other patient-reported outcomes, such as the IKDC and Lysholm.
Clinical Relevance: After ACL reconstruction, patients perceive interval subjective improvements until 1 year postoperatively.
Keywords: maximal medical improvement; minimal clinically important difference; anterior cruciate ligament; patient-reported
outcome measures
Anterior cruciate ligament (ACL) tears are one of the most a successful intervention.29 However, at the time of return
common traumatic knee injuries experienced by athletes in to sport, patients may not be participating at their previous
the United States.53 Management typically includes opera- levels of function.1 Improved function, return to play, and
tive reconstruction to restore knee stability and function decreased pain are the most valued metrics by patients after
and reduce discomfort, with the goal of returning athletes ACL reconstruction.21,32,40 The Lysholm scale, International
to preinjury functionality.57 Outcome reporting from ACL Knee Documentation Committee (IKDC) questionnaire, and
reconstruction includes objective clinical measures, such as Knee injury and Osteoarthritis Outcome Score (KOOS) are
anterior laxity, flexion, and extension, as well as return to outcome measures that assess patient symptomatology and
sport, and subjective patient-reported outcome mea- function with knee-specific questions. However, Short Form
sures.8,10,14,15 Return to play is often viewed as the goal of Health Surveys are utilized to assess a patient’s general
ACL reconstruction and is used by physicians to establish health.30,39 Together, these types of assessments yield a sum-
mation of a patient’s limitations, symptoms, and satisfaction,
thereby recapitulating a patient’s overall well-being.
A change in an outcome metric may be statistically sig-
The American Journal of Sports Medicine
nificant; however, this change may not be meaningfully
1–9
DOI: 10.1177/0363546518803365 detectable by the patient. Thus, the emphasis has shifted
Ó 2018 The Author(s) from utilizing statistical significance toward assessing the
1
2 Agarwalla et al The American Journal of Sports Medicine
Studies included in
METHODS quantave synthesis
(n = 30)
Search Strategy
Figure 1. PRISMA (Preferred Reporting Items for Systemic
The PubMed database was searched on January 5, 2018, Reviews and Meta-Analyses) flow diagram of inclusion
with the following search terms: anterior cruciate ligament process.
and ACL in combination with 2 years, 2-year, 24 months,
24-months, as well as randomized control trial. This cap-
tured 2547 articles that reported data at the 2-year time reconstruction among skeletally mature patients at 1
point. The titles and abstracts of the resulting studies year, 2 years, and at least 1 additional time point before
were reviewed by 2 independent reviewers (A.A., R.N.P.). 2 years. Studies that met inclusion criteria and reported
The full text of the article was reviewed if the abstract outcomes at an additional time point beyond 2 years
mentioned the collection of any clinical outcome at 2 were also included in this investigation (Figure 1). Articles
years or if there was uncertainty about outcome reporting. were excluded if reconstruction was performed for a par-
The citations of included articles were also reviewed to tially torn ACL, outcomes were reported for a skeletally
identify articles that were missed by the initial query. immature patient, outcomes were included at a single
Selection criteria included studies published since 2000, time point, or outcomes were not reported at 2 years. If
that reported clinical outcomes after arthroscopic ACL a study was included and reported a clinical outcome score
§
Address correspondence to Brian Forsythe, MD, Midwest Orthopaedics at Rush, Division of Sports Medicine, Rush University Medical Center, 1611 W
Harrison St, Chicago, IL 60612, USA (email: brian.forsythe@rushortho.com).
*Midwest Orthopaedics at Rush, Rush University Medical Center, Chicago, Illinois, USA.
y
Department of Orthopaedic Surgery, Loma Linda University Medical Center, Loma Linda, California, USA.
z
Department of Orthopaedics, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
One or more of the authors has declared the following potential conflict of interest or source of funding: G.L.C. has received education payments from
Smith & Nephew, Arthrex, and Medwest Associates. N.N.V. has received research support from Arthrex, DJ Orthopaedics, and Arthrosurface; has received
royalties from Arthroscopy and Smith & Nephew; holds stock or stock options from Cymedica, Minivasice, and OMeros; is a paid consultant for Orthosur-
face, Minivasice, Medacta, and Smith & Nephew; and has received other financial support from Pacira Pharmaceuticals. B.J.C. has received research sup-
port from Aesculap/B. Braun; holds stock or stock options from Biometrix and Aqua Boom; receives intellectual property royalties from DJ Orthopaedics,
Elsevier, Encore Medical, and Arthrex; has received other financial support from Athletico, Lifenet Health, and Carticept; is a paid consultant for and has
received research support from Arthrex, Geistlich Pharma, Vericel, Zimmer Biomet, Anika Therapeutics, Genzyme, Pacira Pharmaceuticals, and Isto Tech-
nologies; and has received hospitality payments from GE Healthcare. B.F. has received research support from Arthrex and Stryker; is a consultant for
Stryker and Sonoma Orthopaedics; has received fellowship support from Ossur and Smith & Nephew; holds stock or stock options from Jace Medical;
and has received education payments from Arthrosurface and Medwest Associates. AOSSM checks author disclosures against the Open Payments Data-
base (OPD). AOSSM has not conducted an independent investigation on the OPD and disclaims any liability or responsibility relating thereto.
AJSM Vol. XX, No. X, XXXX Maximal Subjective Improvement After ACL Reconstruction 3
TABLE 1
Studies Meeting Inclusion Criteria for Analysis
at only 2 time points, that particular outcome metric was were previously reported for an individual patient-reported
not recorded for this investigation. outcome measure, the smallest MCID was used for analysis.
Instead of finding the average MCID for that outcome mea-
sure, the smallest MCID was used because a discernible
Data Extraction change in pain or function was noted at that MCID, which
justifies a minimally important clinical improvement. Addi-
Data extraction included title, journal, first author, date of tionally, using the smallest MCID would result in more fre-
publication, study design, enrollment at each reported quent visits and/or a longer duration to maximal medical
time point, study intervention, type of graft, graft fixation subjective improvement, owing to increased sensitivity of
at the femoral and tibial sockets, concomitant injuries, detecting a change in outcome metrics. For scores without
incidence of complications, frequency of reruptures, and an established MCID, statistical significance was used to
patient-reported outcome measures. Clinical outcome scores analyze the change in outcome measures.
included the KOOS, IKDC, Cincinnati Rating System, Short
Form–12 Physical Component (SF-12 Physical), Short
Form–12 Mental Component (SF-12 Mental), Lysholm, Data Analysis
and Tegner Activity Scale. A distribution-based method con-
structed from statistical characteristics of the obtained sam- Data for each patient-reported outcome measure were ana-
ples was used to calculate MCID for those outcome metrics lyzed by the use of reported means and standard deviations.
that had a calculated MCID.37,44,47 MCIDs were previously Clinical outcomes were compared in the following intervals: 6
established for the IKDC (MCID = 9), Lysholm (MCID = 10), weeks to 3 months, 3 months to 6 months, 6 months to 1 year,
SF-12 Physical (MCID = 5.1), and SF-12 Mental (MCID = and 1 to 2 years via weighted averages. The overall weighted
4.3).37 An MCID was also established for each subscore of average score was calculated with the number of patients fol-
the KOOS: Pain (MCID = 1.7), Symptoms (MCID = 1.7), lowed up at each time point for each study. Standard devia-
Activities of Daily Living (MCID = 1.3), Sports (MCID = tion was used to report the distribution of pooled statistics. If
2.2), and Quality of Life (MCID = 2.4).44 If multiple MCIDs a singular study reported a score at an individual time point
4 Agarwalla et al The American Journal of Sports Medicine
TABLE 3
Patient-Reported Outcomes at Different Postoperative Time Pointsa
Preop to 6 wk to 6 wk to 3 mo to 3 mo to 6 mo to 6 mo to 1y
6 wk 3 mo 6 mo 6 mo 1y 1y 2y to 2 y
a
Dashes (—) indicate unavailable time points. IKDC, International Knee Documentation Committee; MCID, minimal clinically important
difference; NA, not available; preop, preoperative; SF-12 Mental, Short Form–12 Mental Component; SF-12 Physical, Short Form–12 Phys-
ical Component.
TABLE 4
KOOS and Tegner Activity Scale at Different Postoperative Periodsa
Preop to 3 mo 3 mo to 6 mo 3 mo to 1 y 6 mo to 1 y 6 mo to 2 y 1 y to 2 y
a
KOOS, Knee injury and Osteoarthritis Outcome Score; MCID, minimal clinically important difference; NA, not applicable; preop,
preoperative.
6 Agarwalla et al The American Journal of Sports Medicine
TABLE 5
Knee Society Score Outcomes at Different Postoperative Time Pointsa
Preop to 6 wk 6 wk to 1 y 6 wk to 2 y 1 y to 2 y
a
MCID, minimal clinically important difference; NA, not applicable; preop, preoperative.
A B
100 100
90 90
80 80
Outcome Scores
Outcome Score
70 70
KOOS Daily
60 IKDC 60
50 50 KOOS Pain
40 Lysholm 40
KOOS QoL
30 SF-12 P 30
20 20 KOOS Symptoms
SF-12 M
10 10 KOOS Sports
0 0
0 1.5 3 6 9 12 15 18 21 24 0 1.5 3 6 9 12 15 18 21 24
Months Postoperavely Months Postoperavely
Figure 2. Trend in (A) patient-reported clinical outcomes and (B) KOOS subscores after ACL reconstruction. ACL, anterior cru-
ciate ligament; IKDC, International Knee Documentation Committee; KOOS, Knee injury and Osteoarthritis Outcome Score; QoL,
Quality of Life; SF-12 M, Short Form–12 Mental Component; SF-12 P, Short Form–12 Physical Component.
may demonstrate more resilience with the recovery process should not hinder the outcomes of this study, since
and return to sport. Thus, the preoperative SF-12 Mental patient-reported outcome measures are recorded prospec-
may recapitulate resilience and be used as a surrogate tively, even if the study was conducted retrospectively.
measure of psychological factors that influence return to The final limitation of this investigation is that an estab-
sport and subjective clinical outcomes.37 lished MCID is specific to the patient population within
Determining when a patient can return to sport is a mul- the study that the MCID was derived. Applying an
tifactorial equation in which time from surgery and subjec- MCID to another study assumes that those populations
tive improvement are not the sole variables. Sensitive are similar.59 Despite the limitations of this study, the
objective measures, such as the single-legged hop test, thigh sample sizes at each time point were large enough to suffi-
circumference, and muscle strength, are frequently ciently power measurements at each interval and instill
assessed during return-to-play evaluation, as limb asymme- confidence in the results.
try is associated with an increased risk of injury.10,14,36,52
According to previously established thresholds, patients
reached a patient-acceptable symptom state35—a
patient-reported outcome measure–based methodology of CONCLUSION
establishing satisfaction—by postoperatively 12 months.
Although return to sport typically occurs between 6 and After ACL reconstruction, maximal medical improvement
13 months postoperatively,25 Ardern et al1 demonstrated is established 1 year postoperatively, with no further
that 81% of patients return to sport at 12 months. How- detectable clinical improvement beyond this time point
ever, only 33% of those patients returned to play at their based on current patient-reported outcome measures.
preinjury activity levels at that time point. As such, utiliz- The KOOS may be a more responsive metric to subjective
ing subjective patient outcomes may better define interval improvements in this patient cohort than other patient-
improvements from ACL reconstruction. Maximal medi- reported outcomes, such as the IKDC and Lysholm.
cal improvement and patient-acceptable symptom state
both demonstrated that patients were satisfied and
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