Knee Injury Outcomes

Measures

Rick W. Wright, MD

Dr. Wright is Associate Professor and

Director, Residency Program,
Department of Orthopaedic Surgery,
Washington University, St. Louis, MO.
Dr. Wright or a member of his immediate
family has received research or
institutional support from Arthrex and
Smith & Nephew, holds stock or stock
options in Wright Medical Technologies,
and has received financial or material
support from Wolters Kluwer Health.
Reprint requests: Dr. Wright,
Department of Orthopaedic Surgery,
Washington University, Suite 11300WP,
1 Barnes Hospital Plaza, St. Louis, MO
63110.
J Am Acad Orthop Surg 2009;17:
31-39
Copyright 2009 by the American
Academy of Orthopaedic Surgeons.

Volume 17, Number 1, January 2009

Abstract
Outcomes measures have long been used in the assessment of knee
injuries and management protocols. In the past decade, there has
been a shift from clinician-based outcomes tools to the
development and validation of patient-reported outcomes
measures. General health as well as disease- and medical
conditionspecific outcomes measures have been so modified. The
Medical Outcomes Study 36-Item Short Form is the most
commonly used general health measure in orthopaedics. Jointspecific measures include the Western Ontario and McMaster
Universities Osteoarthritis Index, the Knee Injury and
Osteoarthritis Outcome Score, and the International Knee
Documentation Committee Subjective Form. The Lysholm Knee
Scale and the Cincinnati Knee Rating Scale continue to be popular,
especially for the assessment of ligamentous injuries. The ACL
Quality of Life score is a disease-specific, patient-reported
outcomes measure of anterior cruciate ligament deficiency. The
historically used Tegner activity level scale and the recently
developed Marx activity level scale are used in conjunction with
these outcomes measures to make possible a global assessment of
recovery from knee injuries and clinician interventions.

easuring the outcome of knee

injuries and their management
by health care personnel is becoming
increasingly important, for several
reasons: (1) the desire by health care
providers to assess injury and treatment outcome,1 (2) increased patient
interest in health and expected outcomes, and (3) a desire by health insurers for value for money spent. Increasingly, these outcomes measures
are patient-based,2 a result of honoring the importance of patient satisfaction versus surgeon satisfaction with
treatment results. Patient satisfaction
has been demonstrated to most
closely follow outcomes scores related to subjective symptoms and
function.3

Some clinicians question the

value of patient-reported outcomes
measures, considering their subjective nature less valid than the more
objective clinician-based outcomes
measures (eg, range of motion, knee
laxity, physical examination tests).4,5
It has become apparent from the results of a variety of studies that, in
actuality, the validity of these
patient-reported outcomes measures
is often better than the clinicianbased objective measures.6-10 For
example, although researchers may
be able to statistically note a 1- to
2-mm difference in KT-1000
(MEDmetric, San Diego, CA) testing
in a patient with a reconstructed anterior cruciate ligament (ACL), we
31

Knee Injury Outcomes Measures

have been unable to detect an associated difference in patient satisfaction.

This raises the question, What is
an excellent result? Is it the result
accepted by a surgeon satisfied by a
KT-1000 side-to-side difference 3
mm, or the result accepted by a patient satisfied with the ability to return to her or his previous level of
activity? Although clinical studies
commonly include both assessments, different studies require separate approaches to this question.
For instance, a study evaluating a
new technical approach to a clinical
condition will require reporting on
functional testing, while a study
evaluating the outcome of an established procedure may rely more
heavily on patient-reported outcomes measures.
Outcomes measures are typically
one of two types: general health or
disease specific.1,11 The general
health measure evaluates a range of
parameters, both mental and physical. A disease-specific measure is focused on the issues most important
to the management and natural history of a single ailment or injury.
Most epidemiologists believe that
studies should include a general
health outcomes measure in addition to disease- or anatomic-specific
measures.12
A number of knee injury rating
scales have been used over the
years,13 with more than 54 outcomes
measures described for evaluating
ACL reconstruction alone.14 Few of
these instruments are validated, and
most are not self-administered. Use
of an observer-dependent outcomes
measure (even if the observer is not
directly involved in patient treatment) introduces bias that is eliminated by self-administered tests.15,16
According to Roos, developer of the
Knee Injury and Osteoarthritis Outcome Score (KOOS), the critical
properties of outcome measures in
general are patient relevancy, user
friendliness, reliability, validity, and
responsiveness to clinical change.17
32

Reliability refers to the ability to

score a measure without errors in a
reproducible fashion.18 Validity is the
ability of an outcomes measure to
evaluate what it claims to measure.19
Responsiveness is the ability to detect a change in condition when it
occurs.20
Table 1 presents the measures
most commonly used today in studies involving knee injuries. Such information may enhance surgeon understanding of published studies and
what outcomes measures might be
practical to apply to individual practices. Outcomes scales measuring
only knee arthroplasty outcomes are
excluded.

Medical Outcomes
Study 36-Item Short
Form
The Medical Outcomes Study 36Item Short Form (SF-36) is currently
the most popular general health outcomes measure. It was derived to assist in health policy development,
clinical practice, and research and
general population surveys.22 The developers of the SF-36 wanted to design
a questionnaire that could be answered in approximately 10 minutes,
while maintaining much of the ability of longer questionnaires (eg, Sickness Impact Profile) to address a variety of general health measures.23-25
A secondary goal was to improve on
the ability to measure general health
outcomes over the previously developed SF-20 without significantly
lengthening the questionnaire. The
SF-36 has been used in more than
1,000 publications to measure over
130 diseases and conditions.26 The
Sickness Impact Profile, a 136-item
questionnaire requiring 20 to 30 minutes to complete, has been used less
often than has the SF-36 in orthopaedic studies.23
The SF-36 questionnaire consists
of 35 questions in eight subscale domains and one general overall health
status question. Each subscale score
is totaled, weighted, and trans-

formed to fall between 0 (worst possible health, severe disability) and

100 (best possible health, no disability).11 The scores are designed so that
the average US citizen would score
50 on a subscale. The questionnaire
typically takes 5 to 10 minutes to
complete.
The measure can be administered
by telephone or by an in-person interviewer; it also can be selfadministered by the patient. Research
indicates that interviewer or telephone administration may be better
in a population that is skewed toward
the elderly or the economically depressed.18 The SF-36 has been validated for a variety of ages and languages; for patients aged 75 years and
older, it is most effective when special modifications are used.25,27-30
Scores can be compared with normative data, but these must come from
large groups with a wide geographic
distribution, as previous studies have
demonstrated regional differences in
scores.31 Language validation includes, but is not limited to, English,
German, Italian, Spanish, Danish,
French, and Swedish.23,32,33 The SF-36
has demonstrated effectiveness in a
variety of conditions pertinent to orthopaedic surgery, including osteoarthritis (OA), rheumatoid arthritis,
shoulder rotator cuff disease, spinal
conditions, foot conditions, hip conditions, and a variety of sports
injuries.11,34-38
The advantage of a general health
outcomes measure is that it can be
used to compare diseases and conditions across the medical spectrum.
This allows researchers to compare
the relative impact of treatment on
patients despite completely different
diagnoses. Patients and clinicians
may believe that the general health
measure is less relevant to the disease condition in question and that
any such measure should be combined with disease-specific outcomes measures that have more
content and validity for that specific condition.12

Journal of the American Academy of Orthopaedic Surgeons

Rick W. Wright, MD

Table 1
Outcomes Measures for Assessing Patients With Knee Injury11,21
Assessment
Parameter

Instrument

Type

Scale

Interpretation

SF-36

PRO

General health

WOMAC

PRO

Condition-specic for Three subscales (questions): pain (5),

OA, lower extremity stiffness (2), physical function (17)

Minimum, 0; maximum, 96 for

global score, subscales
normalized to 0-100 score
The higher the score, the lower
the function, but frequently
transformed to 0 (worst) to
100 (best)

KOOS

PRO

Sports injury (eg,

Five subscales (questions): pain (9),
ACL reconstruction,
symptoms (7), ADLs (17), sports and
meniscectomy, tibial
recreation function (5), knee-related
osteotomy,
QOL (4)
posttraumatic OA)

Scores normalized to 100 for

each subscale; each subscale
is scored separately
Minimum subscale score, 0;
maximum subscale score, 100
The higher the score, the
higher the function

IKDC

PRO

Knee-specic (eg,
18 questions
ligament, meniscus,
articular cartilage
injury; OA;
patellofemoral pain)

Minimum, 0 (worst);
maximum, 100 (best)

Lysholm
Knee
Scale

PRO

Knee ligament
surgery follow-up,
but utilized for a
variety of knee
conditions

Eight subscales (points): limp (5),

support (5), stair climbing (10),
squatting (5), instability (25), locking
and catching (15), pain (25), swelling
(10)

<65 points, poor; 65-83, fair;

84-94, good; 95-100, excellent

Cincinnati
Knee
Rating
Scale

CBO, Ligament injury and

PRO
reconstruction,
HTO, meniscus
repair and allograft
transplant

Six subscales (points): symptoms (20),

daily and sports functional activities
(15), physical examination (25), knee
stability testing (2), radiographic
ndings (10), functional testing (10)

0 (worst) to 100 (best)

ACL QOL

PRO

Chronic ACL
deciency

Five subscales (points): symptoms and Minimum, 0 (worst);

physical complaints (20), work-related maximum, 100 (best)
concerns (20), recreational activities
and sports participation or
competition (20), lifestyle (20), social
and emotional function (20)

Tegner
Activity
Level
Scale

PRO

Sport-specic activity
level

Marx
Activity
Level
Scale

PRO

Functional activity

Scores normalized to 100 for

Eight subscales (questions): physical
each subscale. Minimum, 0
functioning (10), role (physical [4],
emotional [3]), pain (2), general health (worst possible health, severe
disability); maximum, 100
(5), vitality (4), social functioning (2),
(best health, no disability)
emotional well-being (5)

Four questions (points): running (4),

cutting (4), decelerating (4), pivoting
(4)

0 points, disability secondary

to knee problems; 1-5, work
or recreational sports; 6-9,
increasing recreational and
competitive sports, nationalor international-level soccer
0, activity performed <1 time
per month; 4, activity
performed 4 times per week

ACL = anterior cruciate ligament, ACL QOL = ACL Quality of Life Score, ADLs = activities of daily living, CBO = clinicianbased outcome, HTO = high tibial osteotomy, IKDC = International Knee Documentation Committee Subjective Knee Form,
KOOS = Knee Injury and Osteoarthritis Outcome Score, OA = osteoarthritis, PRO = patient-reported outcome, QOL = quality of life,
SF-36 = Medical Outcomes Study 36-Item Short Form, WOMAC = Western Ontario and McMaster Universities Osteoarthritis Index

Volume 17, Number 1, January 2009

33

Knee Injury Outcomes Measures

Western Ontario and

McMaster Universities
Osteoarthritis Index
The Western Ontario and McMaster
Universities Osteoarthritis Index
(WOMAC) was developed, tested,
and formatted to assess pain (5 questions), stiffness (2 questions), and
physical function (17 questions) in
patients with hip and knee OA.39-41
The 24 items are rated on a fivepoint Likert scale or on a 10-cm visual analogue scale. The measure
takes approximately 5 to 10 minutes
to complete. The scores are totaled
for each subscale (maximum totals,
20 [pain], 8 [stiffness], and 68 [physical function]) and normalized to a
100-point scale. A global score can
be given by summing the three subscale scores. The WOMAC is the
most commonly used conditionspecific outcomes measure for OA,
largely because of its sensitivity to
change and its efficiency in use.42-44
In addition, it is the most frequently used patient-reported outcomes
measure for the lower extremity.45
The WOMAC has undergone rigorous validation and has been used in
a large number of studies.40 This measure has been validated for paper, telephone, computer mouse, and touchscreen administration46-49 and has
been developed for use in more than
60 languages, including German, Japanese, French, Italian, Hebrew, Korean, Spanish, and Swedish.50-57 The
WOMAC, which is mostly focused
on the elderly, has been questioned
for use with young, active patients.
The KOOS was created from the
WOMAC as a result of this proposition.58
The minimal clinically important
difference for the WOMAC and SF36 has been evaluated. In a study
evaluating rehabilitation intervention in patients with OA, the minimal clinically important difference
for these outcomes measures was
12% of the baseline score or 6% of
the maximum score.44 Any change
in score less than this, although sta34

tistically detectable, may not be

clinically significant.44 A short-form
version of the WOMAC has been developed and validated to reduce the
response burden,59 but this form has
not yet gained widespread use.
One orthopaedic journal requires
a WOMAC score for all arthroplasty
manuscripts. Previous studies have
demonstrated improved responsiveness and ease-of-use with the
WOMAC compared with the Knee
Society Clinical Rating System for
evaluating total knee arthroplasty.60 In the authors opinion, based
on its popularity, the WOMAC
should be used in all instances in
which OA of the knee may already
be present or is at risk of developing.

Knee Injury and

Osteoarthritis Outcome
Score
First published in 1998, the KOOS
was developed as a patient-reported
assessment tool for evaluating sports
injuries (ie, ACL injuries, meniscus
tears, mild OA) and outcomes in the
young and middle-aged athlete as an
extension of the WOMAC,17,61 as
well as to address both the short- and
long-term aspects of the injury itself
and the longer-term risk of OA following these injuries.17 This outcomes measure evaluates five dimensions: pain (9 items), symptoms
(7 items), activities of daily living (17
items), sport and recreation function
(5 items), and knee-related quality of
life (4 items). To assess OA in the
older individual, the 24 questions of
the WOMAC were included in their
entirety in their original form. This
self-administered measure takes approximately 10 minutes to complete. Each item is graded on a fivepoint Likert scale (0 to 4). Each
subscale is summed and transformed to a score of 0 (worst possible) to 100 (best possible). Although
further research is necessary to delineate more accurately significant
changes in score, it appears that a

change over time of 8 to 10 points in

a subscale is significant.61
The KOOS has been used to assess ACL reconstruction, meniscectomy, tibial osteotomy, and posttraumatic OA.37,62-65 The pain, sport
and recreation, and knee-related
quality-of-life subscales have been
determined to be the most sensitive,
with the largest effect size for active,
younger patients.50,61,62 This measure
may also have unexpected usefulness in active patients following total knee arthroplasty and patellofemoral arthroplasty.38,66 It has
been validated in several languages
but is primarily used in English and
Swedish.62,67 Population-based reference data have been established for
comparison with study populations.
Age and sex differences have been
demonstrated, with statistically
lower scores in women aged 55 to 74
years and in men aged 75 to 84
years.68

International Knee
Documentation
Committee Subjective
Knee Evaluation Form
The International Knee Documentation Committee was established in
1987 to develop a standardized
method for evaluating knee injuries
and treatment. The International
Knee Documentation Committee
Subjective Knee Evaluation Form
(IKDC) was first published in 1993
and revised in 1994. In 1997, the
board of the American Orthopaedic
Society for Sports Medicine moved
to revise the form in light of the
progress in the evaluation of medical
outcomes.69 The result was a jointspecific, rather than a disease- or
condition-specific, tool for evaluating symptoms, function, and sports
activity applicable to a variety of
knee conditions. The resultant subjective form consisted of 18 questions. The form can be scored when
16 of the 18 of the questions are answered (90%). The raw scores are
summed and transformed to a scale

Journal of the American Academy of Orthopaedic Surgeons

Rick W. Wright, MD

of 0 (worst possible) to 100 (highest

possible). The subjective form has
been validated and shown to be reliable and responsive for a variety of
knee conditions, including ligament,
meniscus, and articular cartilage
injuries; OA; and patellofemoral
pain.70,71 A change in score of 11.5
points on the 100-point scale represents an improvement in condition.71 The form is available in English, Spanish, French, Japanese,
German, Dutch, and Italian.72-74
Normative data have been established for a variety of ages and for
each sex.75
The strength of the IKDC lies in
its capacity as a single form to assess
any condition involving the knee,
thus allowing comparison between
groups with different diagnoses.
With only 18 questions, it is simple
to use and lacks excessive responder
burden.

Lysholm Knee Scale

The Lysholm knee scale, published
in 1982 and modified in 1985, was
developed for the follow-up evaluation of knee ligament surgery, with
an emphasis on symptoms of instability.76 It consists of eight items (ie,
limp, support, stair climbing, squatting, instability, locking and catching, pain, swelling) on a 0- to 100point scale.76,77 Pain and instability
are weighted the most heavily, with
a 25-point maximum each. The arbitrarily determined scoring system
indicates 95 to 100 points as excellent, 84 to 94 points as good, 65 to 83
points as fair, and <65 points as
poor.78 When the scale is applied to a
normal population, women consistently scored lower than men.79
This scale represented one of the earliest scoring systems to emphasize
the patients subjective assessment
of symptoms and function; however,
it was not patient-scored.
The Lysholm knee scale quickly
became one of the most widely
adopted outcomes rating measures for
knee ligament surgery,78 having been
Volume 17, Number 1, January 2009

used in more than 100 publications

by 1995.80 Some criticisms of this instrument developed over time. It was
believed to prove more useful for ACL
reconstruction than for meniscectomy and other knee conditions.81,82
Its validity, sensitivity, and reliability, even for patients with ACL injury,
have been questioned,7,81,82 although
other studies have demonstrated it
to be valid for a variety of knee injuries and associated with patient
satisfaction.3,83-85 Some concern regarding a ceiling effect has been expressed; in head-to-head comparisons
with other scoring measures, the Lysholm knee scale has demonstrated
higher scores.7,17,86,87 This score can be
improved when patients self-limit
their activities. Thus, the scale may
prove to be more meaningful when
combined with an activity rating
scale.87 Although the Lysholm knee
scale score continues to have value,
particularly for purposes of historical
comparison, it may best be used in
conjunction with more modern
patient-reported outcomes scores.

Cincinnati Knee Rating

Scale
The Cincinnati knee rating scale was
first described in 1983.88,89 It assessed
subjective symptoms (eg, pain, swelling, giving way) and functional activity level (eg, walking, climbing stairs,
running and jumping, twisting), with
50 points assigned to each, for a total
of 100 points. This was later modified
to a rating system consisting of 13 total scales: 4 symptom scales (pain,
swelling, partial giving way, full giving way), 1 patient perception scale of
the overall knee condition, 3 activities of daily living scales (walking,
stair climbing, squatting), 3 sports
functional scales (running, jumping,
hard twisting/cutting/pivoting), 1
sports activity scale, and 1 occupational activity scale. In time, a sixsubscale, 100-point system was developed: symptoms (20), daily and sports
functional activities (15), physical examination (25), knee stability testing

(20), radiographic findings (10), and

functional testing (10).90
One criticism of this measure is
that the developers have recommended independent examiners
rather than patient-reported selfassessment.91 Portions of the rating
system have been validated.7,90 When
used by researchers other than the developers, it is most commonly used
in the assessment of ACL injuries and
reconstruction; however, it has also
been used to evaluate other disorders.7,83,92,93 Strengths of the scale include its comprehensiveness and
rigorous assessment.86,87 Typically, patients score lower on the Lysholm
scale than on other measures.86,87 An
additional concern is that when used
in studies, often only a portion of the
rating system is used.83

ACL Quality of Life

The ACL Quality of Life score, published in 1998, was developed as a
disease-specific patient-reported outcomes measure of chronic ACL deficiency.94 It consists of 32 items in
five domains (ie, symptoms and
physical complaints, work-related
concerns, recreational activities and
sport participation or competition,
lifestyle, social and emotional function) assessed using a visual analogue scale. The raw score is transformed to a 0-to-100point scale,
with each item weighted equally.
The developers have shown it to be
valid, reliable, and responsive. It has
demonstrated a capability to predict
which patients with chronic ACL
deficiency will require surgery, but it
has not yet become as popular as
other knee rating scales.93,95 This
may change with the increasing emphasis on patient-reported outcomes
and the continued popularity of ACL
research.96

Tegner Activity Level

Scale
The Tegner activity level scale, first
described in 1985, was designed to
35

Knee Injury Outcomes Measures

lend a numeric score to a patients activity level (0 to 10 points).77 Zero represents disability secondary to knee
problems, 1 through 5 represents
work or recreational sports ranging
from sedentary jobs through heavy
manual labor, 6 through 9 represents
increasing recreational and competitive sports, and a score of 10 is assigned to national- or internationallevel soccer. Described by Tegner and
Lysholm,77 this scale has most commonly been used in association with
the Lysholm score. One criticism of
the scale is that it relates activity to
specific sports rather than to the functional activities required to participate in those sports. Thus, cultural
differences in sports played may make
it difficult to apply to the results to
all patients and may limit generalizability. For example, baseball is not
listed as an example sport for this activity scale.97 Formal validation has
not been performed.97 Despite such
criticism, the Tegner activity level
scale has remained popular and is often used in studies. However, its use
may decrease in light of a recently developed validated activity scale (ie,
Marx).97

Marx Activity Level

Scale
The Marx activity level scale was designed to be a short, patient-reported
activity assessment that can be used
in addition to knee rating scales and
general health outcomes measures. It
contains functional activity rather
than sport-specific questions. Frequency performed is included as part
of the assessment. The scale consists
of four questions assessing running,
cutting, decelerating, and pivoting.
Items are scored 0 to 4, depending on
frequency performed, from less than
once per month (0 points) to four or
more times per week (4 points), with
a minimum of 0 to a maximum of 16
points possible. The scale is designed
to assess a patients highest peak activity over the past year.
This scale has undergone valida36

tion testing.97 It is regularly used in

studies, but additional work is needed to determine a score change
equivalent to a significant change in
activity level.98,99 The strength of the
Marx activity level scale lies in its
measure of function rather than
sports activity, its status as a validated scale, and its ease of use (ie, four
items, <1 minute to complete).

Scale Selection
One of the significant challenges in
the use of outcomes measures is in
selecting which measure to use in
which instance. Several studies have
demonstrated that similar rating
scales applied to the same set of
patients will result in different
scores.87,100 No gold standard exists
in rating scales; thus, researchers
and clinicians must assess a tool
based on its applicability to their
specific patient population.
Some general rules do apply, however. Patient-reported outcomes measures continue to demonstrate a
higher association with patient satisfaction but lower scores compared
with clinician-based assessment
tools.16 A general health outcomes
measure, such as the SF-36, should be
used in combination with one or
more disease- or condition-specific
rating scales.12 To avoid overrating patients with low-demand or lowactivity lifestyles, an activity rating
scale such as the Marx or Tegner activity level should be included. Based
on its validation, ease of use, and patient self-assessment construct, the
Marx score will be increasingly used.
Which outcomes measures to use
to evaluate patients with specific
knee conditions is a relevant question for researchers to ask when they
are embarking on a study. The ideal
study, whether a randomized trial or
a longitudinal cohort, will prospectively assess the necessary outcomes
measures. All studies should include
a general health outcomes measure.
When researchers intend to follow
patients for longer than 2 years, the

question of late OA becomes increasingly important. In this case,

the KOOS, which includes the
WOMAC, should be added. The
IKDC, ACL Quality of Life, and Cincinnati Knee Rating Scale should be
considered as a disease-specific measure. The Cincinnati Knee Rating
Scale has demonstrated sensitivity
to changes in ACL reconstruction
follow-up compared with other instruments.7 The Lysholm knee scale
may be considered for historical
comparison and perspective. All
ACL studies should include an activity rating scale, such as the Marx or
Tegner.
Fewer options may be available
for other knee conditions, such as
meniscectomy, patellofemoral pain,
and chondral lesions. Although reported to be validated for conditions
other than ligamentous instability,
the Lysholm knee scale was designed to assess ACL deficiency and
surgical follow-up. For these reasons,
the joint-specific IKDC as well as
the KOOS, with its ability to assess
OA, may be more applicable. A general health outcomes measure (eg,
SF-36) and an activity rating scale
should be included.

Summary
Patient outcomes are more frequently being assessed with patientreported measures that have been
developed using modern test psychometric evaluation, with increasingly rigorous validation studies. Researchers should design clinical
studies with these measures in mind
to allow comparison of interventions both within and without the
specialty of orthopaedics to justify
the health care dollars that are being
spent on our patients.

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Journal of the American Academy of Orthopaedic Surgeons

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