Osteoarthritis is the most common joint tive treatment or placebo in randomized con-
disease, accounting for many physician visits.6 trolled trials.4,5
More than 26 million Americans over age 25 In contrast, the current standard treatment
have some form of it, and the prevalence of for a symptomatic degenerative meniscal tear
symptomatic, radiographically confirmed os- is arthroscopic partial meniscectomy. Nearly
teoarthritis of the knee was 12.1% in the third 500,000 of these procedures are performed
National Health and Nutrition Examination annually in the United States.16 But based on
Survey.7 the best evidence, arthroscopic partial men-
We used to consider osteoarthritis a wear- iscectomy does not result in better pain relief
and-tear diseasethus the term degenera- and functional improvement than does physi-
tive joint disease. But today, we know that cal therapy alone in patients who have a torn
it is an active response to injury, involving meniscus and knee osteoarthritis.17,18
inflammatory and metabolic pathways.8 More-
over, the risk of osteoarthritis and its progres- OVERVIEW OF THE METEOR TRIAL
sion seems to be higher in those who have had The METEOR trial was a randomized con-
meniscal injury and total or arthroscopic par- trolled trial conducted at seven US tertiary re-
tial meniscectomy.9,10 ferral centers. Its aim was to compare the short-
MRI is not commonly used in managing term (6-month) and long-term (12-month)
knee osteoarthritis, but it has been used di- efficacy of arthroscopic partial meniscectomy
agnostically in patients with symptoms of a and physical therapy in patients with symp-
meniscal tear, such as clicking, locking, pop- tomatic meniscal tear and osteoarthritis of
ping, giving way, and pain with pivoting or the knee.19 It was supported by the National
twisting. Traumatic meniscal tears (a longi- Institute of Arthritis and Musculoskeletal and
tudinal or radial tear pattern) most often oc- Skin Diseases.1
cur in active younger people and often lead
to meniscal surgery.11,12 In contrast, degen- Patients were age 45 and older
erative meniscal tears (horizontal, oblique, or METEOR patients had to be at least 45 years
complex tear pattern or meniscal maceration) old and have symptomatic meniscal tears and It may be hard
tend to occur in older people,11,12 but how to knee osteoarthritis detected on MRI or radi- to distinguish
manage them is not widely agreed upon. ography.1
Of note, most patients with osteoarthritis Osteoarthritis was defined broadly, given symptoms
of the knee have torn, macerated, or heavily that it begins well before the appearance of consistent with
damaged menisci.13,14 Meniscal lesions are also radiographic evidence such as an osteophyte
common in middle-aged people in the general
a meniscal tear
or joint-space narrowing.19 Patients with car-
population, with a higher prevalence in peo- tilage defects on MRI were also enrolled, as
ple who are older, heavier, or female, or who were patients with radiographically docu-
have a family history of osteoarthritis.15 mented osteoarthritis.19
These abnormalities are only weakly asso- Patients were considered to have a symp-
ciated with symptoms.2 However, when a pa- tomatic meniscal tear if they had had at least
tient has knee symptoms and a torn meniscus 4 weeks of symptoms (such as episodic pain
is detected on MRI, the tear is often assumed and pain that was acute and localized to one
to be the source of the symptoms, and menis- spot on the knee, as well as typical mechanical
cal tears are the most common reason for ar- pain suggesting a meniscal tear, such as click-
throscopy.16 ing, catching, popping, giving way, or pain
Since we have no way to prevent the pro- with pivoting or twisting) in addition to evi-
gression of joint damage from osteoarthritis dence of a meniscal tear on MRI.19
with drugs or by any other means, the goal Patients were excluded if they had a chron-
is to alleviate the symptoms. Many patients ically locked knee (a clear-cut indication for
report pain relief or functional improvement arthroscopic partial meniscectomy), advanced
after arthroscopic surgery. But arthroscopic osteoarthritis (Kellgren-Lawrence grade 4),
lavage or debridement for osteoarthritis has inflammatory arthritis, clinically symptomatic
not been found to be better than conserva- chondrocalcinosis, or bilateral symptomatic
CL EVELAND CL I NI C J O URNAL O F M E DI CI NE V O L UM E 81 NUM BE R 4 AP RI L 2014 227
METEOR TRIAL
meniscal tears.19 Patients who had undergone was similar to that provided in the nonop-
surgery or injection of a viscosupplement in erative group.1,19
the index knee during the past 4 weeks were Physical therapy was designed to ad-
also excluded.19 dress inflammation, range of motion, muscle
Of 1,330 eligible patients, 351 (26.4%) strength, muscle-length restriction, func-
were enrolled and randomly assigned in a 1:1 tional mobility, and proprioception and bal-
ratio to a treatment group by means of a secure ance.1,19 There were three stages; criteria for
program on the trial website.1,19 Of those who advancing from one phase to the next includ-
were eligible but did not enroll, 195 (14.6%) ed the level of self-reported pain, observed
were not referred and 784 (58.9%) declined to strength, range of knee motion, knee effusion,
participate. Of those who declined, more pre- and functional mobility.1,18
ferred surgery than physical therapy (36.1% The duration of participation varied de-
vs 21%). No information is available on any pending on the pace of improvement. Gener-
differences in baseline characteristics between ally, the program lasted about 6 weeks.1,19
the enrolled patients and the eligible patients
who declined. Crossover and other therapies were allowed
Randomization was done in blocks of vary- Crossover from physical therapy alone to sur-
ing size within each site, stratified according gery was allowed during the trial if the patient
to sex and the extent of osteoarthritis on base- and surgeon thought it was clinically indicated.
line radiography. The extent of osteoarthritis Participants in both groups were permitted
was categorized either as Kellgren-Lawrence to take acetaminophen and nonsteroidal anti-
grade 0 (normal, no features of osteoarthritis) inflammatory drugs as needed. Intra-articular
to grade 2 (definite osteoarthritis, a definite injections of glucocorticoids were also allowed
osteophyte without joint-space narrowing) or during the trial.
as Kellgren-Lawrence grade 3 (moderate os-
teoarthritis, < 50% joint-space narrowing).1,19 OUTCOMES MEASURED
The two treatment groups were similar with
When a torn respect to age, sex, race or ethnicity, baseline WOMAC physical function score
Kellgren-Lawrence grade, and baseline West- The primary outcome of the METEOR trial
meniscus was the difference between the study groups
ern Ontario and McMaster Universities Ar-
is detected thritis Index (WOMAC) physical function in the change in WOMAC physical function
on MRI, it is score.1 score from baseline to 6 months, at which
The mean age of the participants was 58, point participants were expected to have
often assumed and 85% were white. Sixty-three percent had achieved maximum improvement.1,19 Ques-
to be the Kellgren-Lawrence grade 0 to 2 osteoarthritis, tionnaires were also administered at 3 months
and 27% had grade 3.1 to assess the early response to surgery or physi-
source of the cal therapy and again at 12 months.
symptoms Surgery plus physical therapy The complete WOMAC also measures
vs physical therapy alone pain and stiffness in addition to physical func-
The surgery group underwent arthroscopic tion, with separate subscales for each. The
partial meniscectomy, which involved trim- change in WOMAC score is one of the most
ming the damaged meniscus back to a stable widely endorsed outcome measures in assess-
rim1,19 and trimming loose fragments of carti- ing interventions in osteoarthritis or other
lage and bone. conditions of the lower extremities.20 The
After the procedure, patients were sched- METEOR trial authors considered the WOM-
uled for physical therapy. Although there is AC scale to be highly valid and reliable, with
no consensus on the need for or the effec- a Cronbach alpha value of 0.97 (maximum
tiveness of postoperative physical therapy in value = 1; the higher the better).
this setting, the investigators believed that No ceiling or floor effects were observed in
including it in both study groups would help the WOMAC physical function score in pa-
to isolate the independent effects of surgery. tients with osteoarthritis and a meniscal tear
The physical therapy regimen after surgery in a pilot study for METEOR.19
228 CLEV ELA N D C LI N I C JOURNAL OF MEDICINE VOL UME 81 N UM BE R 4 AP RI L 2014
HWANG AND KWOH
In the main METEOR study, WOMAC approach, ie, according to the treatment actu-
physical function was scored on a scale of 0 ally received.1,19 Secondary intention-to-treat
to 100, with a higher score indicating worse analysisusing binary outcome measures in
physical function.1 Changes in the score were which treatment failure was defined as im-
also measured as a yes-or-no question, defined provement in the WOMAC score of less than
a priori as whether the score declined by at 8 points or crossing over to the other treat-
least 8 points, which is considered the mini- mentwas also performed to estimate efficacy
mal clinically important difference in osteoar- at the level of the patient rather than at the
thritis patients.1,19 group level.1,19
pants in the surgery group and 13 participants presents with a sudden onset of intolerable
in the physical therapy group.1 Long-term risks pain after a squatting or twisting injury.
associated with these interventions are being In addition, the study population was pre-
assessed, and longitudinal assessment of imag- dominantly white (85%), and the study was
ing studies is planned to address this question performed in tertiary referral academic medi-
but is not yet available.1,18 cal centers. Therefore, the outcomes achieved
In the physical therapy group, 21 patients with surgery or physical therapy may not
(12%) received intra-articular glucocorticoid translate to the community setting. Clinicians
injections, as did 9 patients (6%) in the sur- must be careful to account for these types of
gery group.1,19 differences in extrapolating to patients in
their own practice.
TRANSLATING THE METEOR RESULTS
TO EVERYDAY PRACTICE Potential enrollment bias
There are many challenges in designing surgi- Although randomization is a rigorous method
cal trials. Indeed, by one estimate,22 only about that eliminates selection bias in assigning in-
40% of treatment questions involving surgical dividuals to study and control groups, selec-
procedures can be evaluated by a randomized tive enrollment could have created bias.1 As
controlled trial. the authors mentioned, only 26% of eligible
Although the METEOR trial was not blind- patients were enrolled, possibly reflecting pa-
ed, it was the first large, multicenter, randomized tients or surgeons strong preferences for one
controlled trial to compare arthroscopic partial treatment or the other. Because the study and
meniscectomy vs standardized physical therapy control groups were hardly random samples
by using high-quality methodology such as care- of eligible populations, we must be careful in
ful sample-size calculation, balancing the groups generalizing the efficacy of physical therapy.1
according to known prognostic factors with block
randomization, and intention-to-treat analysis. Crossover may have obscured
Moreover, the outcome measures were obtained the benefit of surgery
Of 1,330 eligible from validated self-reporting questionnaires During the first 6 months, 30% of patients
patients, (WOMAC for function and KOOS for pain), crossed over from physical therapy to surgery.
reducing the possibility of observer bias.19 In ad- High crossover rates in surgical trials are com-
351 (26.4%) dition, analyses were performed with the analysts mon, especially when comparing surgery with
were enrolled blinded to the randomization assignment. medical therapy.23 Given that most of the pa-
tients assigned to only physical therapy who
and randomized Limitations of the trial crossed over to surgery did not have substan-
A few limitations of the study are worth noting. tial improvement in functional status, it seems
Patients age 45 or older with both symp- that crossover occurred by nonrandom factors,
tomatic meniscal tear and osteoarthritis were potentially biasing the study results. With the
the target population of this study. However, it high degree of crossover from the nonopera-
is important to distinguish between the study tive group to the surgical group, intention-to-
population and the target population in a phy- treat analysis may have given an inflated esti-
sicians practice. mate of the effect of physical therapy.
The investigators adopted broad defini- To account for crossovers, researchers de-
tions of osteoarthritis and symptoms of menis- fined a binary outcome a priori: patients were
cal tear. Twenty-one percent of participants considered to have had a successful treatment
had normal findings on plain radiography, response if they improved by at least 8 points
with cartilage defects visible only on MRI. on the WOMAC scale (a clinically important
Further, episodic pain or acute pain localized difference) and did not cross over from their
to a joint line was regarded as a symptom con- assigned treatment. At 6 months, 67.1% of
sistent with a torn meniscus. patients assigned to surgery showed a success-
In practice, arthroscopic partial menis- ful treatment response, compared with 43.8%
cectomy is usually considered when a patient of patients assigned to physical therapy alone
with a long history of tolerable osteoarthritis (P = .001).1
230 CLEV ELA N D C LI N I C JOURNAL OF MEDICINE VOL UME 81 N UM BE R 4 AP RI L 2014
HWANG AND KWOH
In patients who crossed over, the last scores consistent with degenerative meniscal
before crossover were carried over, and primary tear but no knee osteoarthritis were ran-
analysis of the WOMAC score at 6 months was domized to undergo arthroscopic partial
repeated to estimate the effect of crossovers meniscectomy or a sham procedure. At
from the nonoperative to the surgery group. 12 months, no differences were noted be-
This exploratory analysis showed a 13.0-point tween the groups in terms of change of
improvement in WOMAC score at 6 months symptoms from baseline to 12 months.
with physical therapy alone vs a 20.9-point The authors concluded that the outcomes
improvement with surgery, suggesting that the with meniscectomy were no better than with
similarity in outcomes between the two groups a sham procedure.24
may be explained in part by additional im-
provements from surgery for those who crossed SURGERY FIRST,
over from physical therapy alone.1 OR PHYSICAL THERAPY FIRST?
Implications for functional improvement The use of knee arthroscopy has increased
Lacking a comparison group that underwent a sharply in middle-aged patients in recent
sham surgical procedure, one cannot conclude years. Indeed, this demographic group ac-
that surgery after crossover improved function- counts for nearly half of the knee arthroscopic
al status in those patients. However, there was procedures performed for meniscal tears, al-
no significant difference in WOMAC physical though the increase may be due in part to is-
function scores at 12 months between the 30% sues with surgeons coding and insurance au-
of patients in the physical therapy group who thorization.16
crossed over and underwent surgery during the The METEOR trial showed that a struc-
first 6 months and patients initially assigned tured physical therapy program can be as effec-
to surgery. This finding suggests that physi- tive as surgery as a first-line therapy in many
cal therapy can be recommended as a first-line patients with symptomatic meniscal tears and
mild to moderate osteoarthritis. These results
therapy, although we must be cautious, given
should inform clinical practice in that most
that the physical therapy group required more Mean declines
such patients need not be immediately re-
background therapy (eg, intra-articular gluco-
corticoid injections), and that this study was not
ferred for surgical intervention. in WOMAC
However, a subset of these patients may
powered to detect such differences at 12 months.
benefit from surgery rather than nonoperative scores at
Also, a patient may need to get better quick-
ly, to get back to work, for example. Although
therapy. Given the potential risks and public 6 months:
health implications of arthroscopic surgery for 20.9 points
the data were not definitive, at 3 months the
meniscal tears, further study is needed to bet-
patients in the surgery group seemed to have with surgery
ter characterize these patients. A randomized
better pain control and function than those
sham-controlled trial is under way25 with the vs 18.5 with
in the physical therapy group. A cost-benefit goal of assessing the efficacy of arthroscopic
analysis of physical therapy compared with partial meniscectomy for medial meniscus physical
surgery for short-term outcomes may be help-
ful before generalizing these findings.
tears in patients with or without knee osteo- therapy
arthritis, and it is hoped this study will shed
further light on this issue.
SURGERY VS SHAM PROCEDURE: Based on the results of the METEOR trial,
THE FIDELITY GROUP RESULTS the physical therapy regimen that was used may
In a later publication from the Finnish De- be reasonable before referring patients with
generative Meniscal Lesion Study (FIDEL- knee osteoarthritis and symptomatic meniscal
ITY) Group,24 146 patients with symptoms tears for surgery.