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RESEARCH

open access
Exercise therapy versus arthroscopic partial meniscectomy for
degenerative meniscal tear in middle aged patients: randomised
controlled trial with two year follow-up
Nina Jullum Kise,1 May Arna Risberg,2,3,4 Silje Stensrud,2 Jonas Ranstam,5 Lars Engebretsen,3,6,7
Ewa M Roos8

1Department of Orthopaedic ABSTRACT At three months, muscle strength had improved in the
Surgery, Martina Hansens Objective exercise group (P0.004). No serious adverse events
Hospital, PO box 823, N-1306 To determine if exercise therapy is superior to occurred in either group during the two year follow-up.
Sandvika, Norway
2Norwegian Research Centre for
arthroscopic partial meniscectomy for knee function in 19% of the participants allocated to exercise therapy
Active Rehabilitation, Oslo, middle aged patients with degenerative meniscal crossed over to surgery during the two year follow-up,
Norway tears. with no additional benefit.
3Division of Orthopaedic
Design Conclusion
Surgery, Oslo University
Hospital, Norway Randomised controlled superiority trial. The observed difference in treatment effect was minute
4Department of Sports Setting after two years of follow-up, and the trials inferential
Medicine, Norwegian School of Orthopaedic departments at two public hospitals and uncertainty was sufficiently small to exclude clinically
Sport Sciences, Oslo, Norway relevant differences. Exercise therapy showed positive
5Department of Orthopaedics,
two physiotherapy clinics in Norway.
effects over surgery in improving thigh muscle
Clinical Sciences Lund, Lund Participants
University, Sweden
strength, at least in the short term. Our results should
140 adults, mean age 49.5 years (range 35.7-59.9),
6Faculty of Medicine, University encourage clinicians and middle aged patients with
with degenerative medial meniscal tear verified by
in Oslo degenerative meniscal tear and no definitive
magnetic resonance imaging. 96% had no definitive
7Oslo Sports Trauma Research radiographic evidence of osteoarthritis to consider
radiographic evidence of osteoarthritis.
Centre, Norwegian School of supervised exercise therapy as a treatment option.
Sport Sciences, Oslo, Norway Interventions
Trial registration
8Research Unit for
12 week supervised exercise therapy alone or
Musculoskeletal Function and www.clinicaltrials.gov (NCT01002794).
arthroscopic partial meniscectomy alone.
Physiotherapy, Institute of
Sports Science and Clinical Main outcome measures
Biomechanics, University of Introduction
Intention to treat analysis of between group difference
Southern Denmark, Odense, In the Western world, as many as 300 in 100000
Denmark in change in knee injury and osteoarthritis outcome
people undergo arthroscopic partial meniscectomy
Correspondence to: score (KOOS4), defined a priori as the mean score for
annually.1-3 In Denmark, the surgery rate doubled from
N J Kise nina.kise@mhh.no four of five KOOS subscale scores (pain, other
2000 to 2011,4 with three out of four patients aged more
Additional material is published symptoms, function in sport and recreation, and knee
than 35 years.4 In these patients, most meniscal tears
online only. To view please visit related quality of life) from baseline to two year
the journal online. are degenerative and might be regarded as the first sign
follow-up and change in thigh muscle strength from
Cite this as: BMJ 2016;354:i3740 baseline to three months. of osteoarthritis.56
http://dx.doi.org/10.1136/bmj.i3740 In a recent meta-analysis, the authors concluded that
Results a small but inconsequential benefit is seen from treat-
Accepted: 26 June 2016
No clinically relevant difference was found between
ment interventions that involve arthroscopy.7 This
the two groups in change in KOOS4 at two years (0.9
small effect is of short duration and absent one year
points, 95% confidence interval 4.3 to 6.1; P=0.72).
after surgery.7 Only one8 in five randomised controlled
trials8-13 found greater pain relief one year after partial
What is already known on this topic meniscectomy compared with non-surgical treatment.8
Interventions that include knee arthroscopy are associated with a small benefit and Short term and long term follow-up studies have shown
with harms; the small benefit is inconsequential and of short duration that exercise therapy improves function and activity
Most previous studies were performed in patients with radiographic evidence of level in patients with degenerative meniscal tears,
knee osteoarthritis regardless of whether they have surgery.9-1113
Only one small pilot study (n=17) compared the effect
Those studies were designed to study the additional benefit from knee arthroscopy,
of surgery alone with exercise alone.14 Of the five other
and the exercise programmes were often of insufficient quality
published randomised controlled trials,8-13 four8-1113
What this study adds were designed to study the effect of surgery in addition
Exercise therapy and knee arthroscopy were similarly effective for pain relief and to exercise therapy, and the remaining study12 com-
other patient reported outcomes in a younger, more active population with a lower pared meniscectomy to sham surgery. Considering the
body mass index than previously studied large amount of surgery performed worldwide, and the
inconsequential short term additional pain relief seen
Exercise therapy resulted in better thigh muscle strength than surgery
from surgery in addition to exercise, randomised con-
Supervised exercise therapy should be considered as a treatment option for
trolled trials are needed to explore the comparative
patients with pain and degenerative meniscal tears verified by magnetic resonance
treatment effect of partial meniscectomy alone with
imaging, and without radiographic signs of osteoarthritis
supervised exercise therapy alone. Furthermore, only

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RESEARCH

two of the five published randomised controlled trials two orthopaedic surgeons confirmed eligibility for
included patients with no definitive radiographic evi- surgery based on the patients history, physical exam-
dence of osteoarthritis.1213 The aim of this study was to ination, and findings on magnetic resonance imaging.
determine if exercise therapy is superior to arthroscopic Exclusion criteria were acute trauma, locked knee, liga-
surgery for knee function in middle aged patients with ment injury, and knee surgery in the index knee during
degenerative meniscal tears verified by magnetic reso- the previous two years.
nance imaging.
Interventions
Methods The exercise therapy intervention was carried out at
Trial design one of two clinics (Norwegian Sports Medicine Clinic
In this randomised controlled trial with two parallel and Gnist Trening og Helse AS), using the same protocol
intervention groups (1:1 ratio) we compared exercise and started as soon as possible after randomisationor
therapy alone with arthroscopic partial meniscectomy later if preferred by the participant. The exercise ther-
alone. Follow-up assessments were performed at three, apy programme, outlined in supplementary figure S1
12, and 24 months, with muscle strength at three and previously described in detail,20 consisted of
months and patient reported outcomes at the two year progressive neuromuscular and strength exercises over
follow-up as the primary end points. Whereas data at 12 weeks, performed during a minimum of two and a
three and 12 months were collected during clinic visits, maximum of three sessions each week (24-36 sessions).
the follow-up at two years was conducted by post, and The participants filled in exercise diaries, and we
we only collected data on patient reported outcomes. assessed compliance with exercise as the total number
of exercise sessions completed out of 24 sessions. Excel-
Deviations from trial registration lent compliance was predefined as participation in 24
Owing to financial and logistical constraints, we con- or more sessions (100%), satisfactory compliance as
ducted tests on muscle strength and performance at 12 19-23 sessions (80-100%), and poor compliance as 18 or
months instead of the 24 months stated in the trial reg- fewer sessions (<80%). In the per protocol analysis, we
istration. Muscle strength at three months for the first defined completing 18 or fewer sessions as not follow-
82 patients has been previously reported.15 A recent ing the protocol. Likewise, if participants in the menis-
meta-analysis of surgically treated patients found that cectomy group received physiotherapist instructed
weakness of the extensor muscle already existed in legs exercise therapy postoperatively of adequate quality for
before surgery, and this remained largely for at least at least 18 sessions, they were defined as not following
four years after surgery.16 Considering these results, we the protocol.
did not think that obtaining muscle function at 24 Arthroscopic surgery was performed as soon as pos-
months in addition to at 12 months would have changed sible after randomisation, depending on waiting lists
the interpretation of our results. Radiographs will be and participant preference. The arthroscopic interven-
obtained at the five year follow-up and are therefore tion was similar in both hospitals, performed as stan-
unavailable for this two year report. Quality of life (EQ- dard operations for arthroscopic partial meniscectomy,
5D) was not analysed at two years but will be reported and the participants followed normal preoperative,
as intended at five years. perioperative, and postoperative routines. Six ortho-
paedic surgeons with at least 10 years of clinical experi-
Participants ence performed the operations. One surgeon performed
Between October 2009 and September 2012, we 39 (61%) operations, and the other five surgeons per-
recruited participants from the orthopaedic depart- formed 1-15 operations each. The participants were dis-
ments at Oslo University Hospital (October 2009-April charged from hospital on the day of surgery and were
2011) and Martina Hansens Hospital (May 2011-Septem- advised to use two crutches postoperatively until gait
ber 2012) in Norway. All patients provided informed normalised and no swelling or discomfort occurred
written consent before participation. during weight bearing. Before hospital discharge the
Inclusion criteria were age 35-60 years; unilateral participants were given written and oral instructions for
knee pain for more than two months without a major simple home exercises, aimed at regaining knee range of
trauma (defined as sudden onset of knee pain resulting motion and reducing swelling. They were encouraged to
from a single physical impact event); medial degenera- perform the exercises two to four times daily (see sup-
tive meniscal tear verified by magnetic resonance imag- plementary figure S2a-d for written instructions).
ing; and, at most, radiographic changes equivalent to Surgery was performed with the participant under
grade 2 according to the Kellgren-Lawrence classifica- general anaesthesia, with or without thigh tourniquet,
tion.17 Standing posterior-anterior radiographs were antibiotic prophylaxis, or antithrombotic prophylaxis.
taken in a fixed flexion position, using a Synaflexer Arthroscopes with 30 degree optics and standard
(Synarc, Newark, CA) frame.18 We defined a degenera- arthroscopic instruments were used. Ringer acetate
tive meniscal tear as an intrameniscal linear magnetic was used for lavage. Normal procedure involved two
resonance imaging signal penetrating one or both sur- portals: anteromedial and anterolateral, and if
faces of the meniscus.19 Furthermore, the patients had required, additional portals were made and a lavage
to be eligible for arthroscopy, be able to participate in cannula was inserted laterally in the cranial recess.
exercise therapy, and understand Norwegian. One of A diagnostic procedure including evaluation of

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dditional injuries (ligaments, cartilage) preceded sys-


a articipating hospitals. We defined any situations
p
tematic probing of both menisci, and, finally, all unsta- where participants sought healthcare as adverse events,
ble meniscal tissue was resected. with death, cardiovascular or gastrointestinal events,
deep vein thrombosis, pulmonary embolism, and sys-
Primary outcomes temic or local infection categorised as serious adverse
Our two primary endpoints were patient reported knee events. We categorised knee symptoms such as pain,
function at two years and thigh muscle strength at three swelling, instability, and decreased range of motion as
months. The primary patient reported endpoint was adverse events only if the participant sought treatment.
change from baseline to two years in KOOS4, defined as The participants were encouraged to contact the partic-
the average score for four of the five knee injury and ipating hospitals for additional clinic visits with the
osteoarthritis outcome score (KOOS) subscale scores orthopaedic surgeon if needed.
covering pain, other symptoms, function in sport and
recreation, and knee related quality of life. KOOS is reli- Sample size
able and has content validity for patients with meniscal The sample size calculation was based on the change in
tears and osteoarthritis.2122 It consists of 42 items scored KOOS4 from baseline to two year follow-up. To detect a
from 0-4 on a Likert scale. Subscale scores are calcu- 10 point difference with a standard deviation of 15, with
lated separately and transformed to a scale from 0 a level of power of 90%, level of significance of 0.05,
(worst) to 100 (best). A priori, a clinically relevant dif- and an estimated 15% dropout rate at two years, we
ference of 10 points guided the sample size calculation. determined that we would need 56 participants in each
To better guide clinical interpretation, we calculated group. To allow for a 20% crossover rate, we ran-
study specific and subscale specific cut-offs post hoc by domised 140 participants.
subtracting the mean KOOS subscale score for those
reporting to have unchanged knee function from Randomisation
those reporting better knee function at two years, on Participants contributed baseline data before they
a five point global rating scale (much better, better, were randomly allocated to one of two parallel inter-
unchanged, worse, or much worse).23 vention groups, treated with either arthroscopic partial
Experienced physiotherapists used detailed test pro- meniscectomy or exercise therapy. A statistician at
tocols to collect data on muscle strength. A Biodex 6000 Oslo University Hospital determined the computer gen-
dynamometer was used to test the strength of quadri- erated randomisation sequence, stratified by sex in
ceps and hamstrings concentric isokinetic muscle. The blocks of eight, and these were concealed from the sur-
outcomes were peak torque and total work for both geons who enrolled and assessed the participants. The
knee extension and knee flexion at 60 degrees per sec- allocations were kept in sequentially numbered
ond. The reliability for isokinetic muscle tests is satis- opaque envelopes that were opened by the participants
factory.24 after enrolment.

Secondary outcomes Blinding


Secondary patient reported outcomes were the five The test assessors were blinded to group allocation, and
KOOS subscales and the physical component summary long pants or neoprene sleeves were worn by partici-
and mental component summary of the short form 36 pants over both knees to hide possible surgical scars and
item (SF-36).25 Secondary objective outcomes were thigh preserve blinding of group allocation. The statistician
muscle strength and lower extremity performance test was blinded to group allocation during the analysis.
results.
We used three reliable and valid performance Statistical analysis
tests26-28 to evaluate lower extremity function: the one The statistical analyses were performed according
leg hop test for distance (measuring length in centime- to the a priori published statistical analysis plan
tres), the 6 m timed hop test (measuring time in sec- (http://static.sdu.dk/mediafiles//5/E/5/%7B5
onds), and the knee bends test (measuring maximum E568A02-9475-4127-9B6C-0ADA7235DF77%7DSAP%20
number in 30 seconds). These test procedures have OMEX%2020.03.15.pdf). All participants assigned to
been described previously.29 The test protocol included treatment were included in the intention to treat anal-
a 10 minute warm-up on a stationary bicycle, followed ysis. Between group comparison of the primary patient
by the muscle strength and lower extremity perfor- reported endpoint, change in KOOS4 from baseline to
mance tests. The first leg to be tested was determined by two year follow-up, was made with the use of a
randomisation, and the same order was applied at the repeated measures mixed model, stratified by sex and
follow-up assessments. Tests of thigh muscle strength study site and with adjustment for baseline imbalance
and lower extremity performance were conducted at of KOOS4 scores.
baseline and at three and 12 month follow-ups. We analysed between group comparisons of the
Adverse events and serious adverse events were change from baseline to the 12 month and 24 month fol-
recorded and categorised into index knee or other sites. low-up assessments on secondary outcome measures
At all follow-up assessments we asked the participants (the five KOOS subscales, SF-36 physical component
about potential adverse events, and at the two year summary and mental component summary, and perfor-
follow-up we checked the medical charts from the mance tests) by intention to treat, similar to the primary

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outcome measures. In addition to the intention to treat Patient involvement


analysis, we performed per protocol and as treated No patients were involved in setting the research ques-
analyses. We present the KOOS, SF-36, and performance tion or the outcome measures, nor were they involved in
scores as means with 95% confidence intervals. developing plans for recruitment, design, or implemen-
IBM SPSS Statistics version 22 (IBM, Armonk, NY) tation of the study. No patients were asked to advise on
was used for descriptive analysis of baseline data, and interpretation or writing up of results. When the results
Stata v14 (Stata 2015, College Station, TX) was used for of this randomised controlled trial are published, infor-
analysis of outcomes at three, 12, and 24 months. The mation will be conveyed to the participants in lay lan-
mixed model analysis was based on the assumption that guage in a pamphlet distributed by email.
the covariance structure had a compound symmetry
that is, that the total variation could be partitioned Results
into two components representing variation between Out of 341 patients assessed for eligibility, 226 were eli-
participants and within participants. The model was gible and 140 (41%) were randomised to the two treat-
fitted using the mixed-command, and we used ment groups, each with 70 participants. Questionnaires
Satterthwaites method to calculate the degrees of were completed by 129 participants (92%) at three and
freedom.30 12 months and 126 (90%) at two years (fig 1).

Assessed for eligibility (n=341)

Did not meet inclusion criteria (n=115):


No knee pain (n=24)
Bilateral knee pain (n=15)
Not able to perform physical activity (n=16)
Norwegian not first language (n=13)
Kellgren Lawrence osteoarthritis grade 3/4 (n=11)
Not eligible for arthroscopic partial meniscectomy (n=7)
No meniscus tear on magnetic resonance imaging (n=7)
Too young or too old (n=5)
Ligament injuries (n=3)
Mental problems (n=3)
Other (n=11)

Eligible (n=226)

Excluded (n=86):
Refused to participate (n=85):
Not willing to undergo exercise therapy (n=52)
Not willing to undergo arthroscopic partial meniscectomy (n=17)
Not willing to participate in scientific trial (n=5)
Distance to trial locations (n=11)
Other injury occurred (n=1)

Randomised (n=140)

Exercise therapy group (n=70) Arthroscopic partial meniscectomy group (n=70)

Exercise therapy not completed (n=10) Surgery not perfomed (n=6):


Did not show up, not willing (n=1)
Too few symptoms on day of surgery (n=5)

Received allocated intervention (n=60): Received allocated intervention (n=64)


Good compliance (80% of exercise sessions) (n=43)
Poor compliance (<80% of exercise sessions) (n=15)
Lost diary (n=2)

3 month follow-up 3 month follow-up


Questionnaire (n=65); questionnaire not returned (n=5) Questionnaire (n=64); questionnaire not returned (n=6)
Tested (n=63); tests not attended (n=7) Tested (n=60); tests not attended (n=10)

, KOOS4
12 month follow-up 12 month follow-up
not completed (n=1)
Questionnaire (n=63); questionnaire not returned (n=6), KOOS4 Questionnaire (n=66); questionnaire not returned (n=4)
not completed (n=1) Tested (n=61); tests not attended (n=9)
Tested (n=59); tests not attended (n=7)

2 year follow-up 2 year follow-up


Questionnaire (n=62); questionnaire not returned (n=8) Questionnaire (n=64); questionnaire not returned (n=5), KOOS4
not completed (n=1)

Fig 1 | Flow chart of participants through study. KOOS4=mean of knee injury and osteoarthritis outcome score subscales
for pain, other symptoms, function in sport and recreation, and knee related quality of life

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In the exercise group, 43 out of 70 (61%) participants articipants out of 70 (9%) did not undergo surgery,
p
completed the exercise therapy programme with satis- owing to personal preference (one participant) or too
factory (17 participants) or excellent (26 participants) few knee symptoms on the day of surgery (five partici-
compliance. These participants on average completed pants) (fig1).
25 exercise sessions (median 25, range 19-36). Fifteen In the intention to treat analyses, the participants
participants had poor compliance, 10 declined exercise were included as randomised. Those who did not com-
therapy, and two had lost their exercise diaries. In plete the assigned treatments were excluded from the
the arthroscopic partial meniscectomy group, six per protocol analysis (see supplementary figure S3).
Thirteen out of 70 participants (19%) in the exercise
group crossed over to receive surgical treatment
Table 1 | Baseline characteristics of participants allocated to exercise therapy or arthroscopic between three and 16 months (mean 7.7 months) after
partial meniscectomy. Values are means (standard deviations) unless stated otherwise inclusion. Of these, approximately half had completed
Characteristics Exercise group Meniscectomy group at least 19 exercise sessions. Participants who crossed
Demographics: n=70 n=70 over to surgery were analysed in the meniscectomy
No (%) men 43 (61) 43 (61) group in the as treated analysis (see supplementary
No (%) right knee 41 (59) 41 (59) figure S3).
Age (years) 50.2 (6.2) 48.9 (6.1) Five participants in the meniscectomy group received
Body mass index (weight (kg)/(height (m)2)) 26.4 (4.3) 26.0 (3.7) passive postoperative physiotherapy (median 2 sessions,
No (%) smokers 3 (4.2) 10 (14.3) range 1-3), but none crossed over to exercise therapy.
No (%) use analgesics daily 3 (4.2) 3 (4.2) Owing to persistent knee pain and catching of the
No (%) primary school education only 3 (4.2) 2 (2.9)
knee, two participants (3%) in the meniscectomy group
No (%) education at university level 37 (53) 36 (51)
were reoperated on at 12 and 15 months, respectively,
Severity of radiographic knee osteoarthritis*: n=70 n=70
and one participant who had crossed over underwent
Grade 0 49 (70) 51 (73)
Grade 1 18 (26) 16 (23)
another operation six months after the primary opera-
Grade 2 2 (3) 3 (4) tion. One participant in the meniscectomy group and
Grade 3 1 (1) 0 one participant who crossed over from the exercise to
Magnetic resonance imaging: n=69 n=70 meniscectomy group (both with Kellgren-Lawrence
Meniscal degeneration grade 1 osteoarthritis) underwent osteotomy at six and
No (%) grade 1-2 6 (9) 6 (9) 16 months, respectively, after the index surgery, owing
No (%) grade 3a-3b 63 (91) 64 (91) to increasing pain and further impaired knee function,
Meniscal extrusion which was related to osteoarthritis as diagnosed by the
No (%) no extrusion 24 (35) 35 (50) surgeon who followed them clinically. A third partici-
No (%) extrusion 45 (65) 35 (50)
pant, in the meniscectomy group (Kellgren-Lawrence
Pain: n=70 n=69
grade 1 osteoarthritis), was given a diagnosis of osteoar-
Duration (months) 17.3 (21.5) 12.0 (15.7)
thritis and treated with passive physiotherapy and
Knee function: n=67 n=63
Visual analogue scale (0-100, worse to best) 57.9 (21.5) 63.8 (18.9)
non-steroidal anti-inflammatory drugs. One participant
KOOS scores (0-100, worst to best): n=70 n=70 from each group underwent arthroscopic partial menis-
KOOS 4 54.3 (18.2) 59.6 (13.8) cectomy of the contralateral knee at six months and
Pain 63.4 (20.8) 67.6 (14.9) four months, respectively.
Symptoms 69.8 (16.7) 77.4 (14.6)
Activities of daily living 75.0 (21.5) 79.6 (16.1) Baseline data
Function in sport and recreation 44.0 (25.8) 47.8 (23.4) Table 1 presents the baseline characteristics of the par-
Knee related quality of life 40.0 (17.5) 45.6 (15.5) ticipants.
SF-36 points (0-100, worst to best): n=70 n=70 On an extra inspection of the radiographs, one partic-
Physical component summary 45.4 (8.4) 47.4 (6.1) ipant allocated to the exercise group was found to have
Mental component summary 55.0 (9.2) 56.0 (6.3)
Kellgren-Lawrence grade 3 osteoarthritis, which was an
Muscle strength (higher is better): n=70 n=70
exclusion criterion. This participant was thus uninten-
Peak torque extension (Nm) 157.5 (48.7) 163.1 (53.2)
tionally included, but had fulfilled all the follow-up
Total work extension (J) 772.9 (245.1) 790.8 (254.8)
Peak torque flexion (Nm) 81.9 (27.2) 88.5 (25.7)
assessments and was retained in all appropriate analy-
Total work flexion (J) 448.3 (187.8) 492.9 (158.7) ses because the results in a sensitivity analysis exclud-
Performance tests: n=69 n=69 ing this participant did not differ.
One leg hop test (cm) (higher is better) 76.6 (32.8) 83.2 (35.5)
6 m timed hop test (sec) (lower is better) 3.1 (1.7) 2.7 (1.2) Primary outcomes
Knee bends 30 sec test (No) (higher is better) 28.2 (10.6) 29.3 (10.6) The study specific and subscale specific cut-off for a
KOOS=knee injury and osteoarthritis outcome score; SF-36=36 item short form; Nm=Newtonmetre; J=Joule. clinically relevant difference between groups in KOOS4
*Kellgren-Lawrence classification.
Although inclusion was based on clinical readings of baseline magnetic resonance images by several
was 10.1. In the intention to treat analysis, there was no
radiologists and orthopaedic surgeons, the data presented here originate from post hoc reading by one clinically relevant difference in change between groups
radiologist blinded to group allocation and study outcome. from baseline to two year follow-up in KOOS4 score (0.9
Graded according to Crues etal.19
Evaluated on coronal sequence images, with largest tibial spine volume, defined as meniscal subluxation points, 95% confidence interval 4.3 to 6.1; P=0.72) after
crossing a vertical line on the medial margin of tibia without osteophytes. adjustment for baseline imbalance and randomisation
n=70 participants.
stratification factors. The mean improvements were 25.3

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30 improvement in KOOS4 at two years. For the intention to

Change in KOOS4
treat population, 80% in the exercise group and 81% in
25
the meniscectomy group improved more than 10.1
20 points, with little difference in the per protocol (81%
15
and 79%, respectively) and as treated populations (81%
and 79%, respectively).
10 The exercise group had significantly greater improve-
Exercise therapy
5 ment in all muscle strength variables at three months
Arthroscopic partial meniscectomy (P0.004) (fig 3). Results were similar for the per protocol
0 and as treated analyses (see supplementary table S2).
0 3 12 24
Follow-up (months)
Secondary outcomes
Fig 2 | Primary patient reported outcome: intention to treat Figures 3-5 show the results of the secondary outcomes
analysis of change in mean score for knee injury and
at three months, 12 months, and two years (also see
osteoarthritis outcome subscale (KOOS4) scores for pain,
symptoms, function in sports and recreation, and knee supplementary tables S1 and S2). From baseline to two
related quality of life in exercise therapy group and year follow-up, the exercise group had a 5.3 point statis-
arthroscopic partial meniscectomy group, from baseline to tically significant but clinically insignificant greater
three month, 12 month, and two year follow-ups. Whiskers improvement in scores on the KOOS subscale for symp-
represent 95% confidence intervals toms than the meniscectomy group (95% confidence
interval 0.5 to 10.2; P=0.03). The study specific and sub-
points (21.6 to 29.0) in the exercise group and 24.4 points scale specific cut-offs for interpretation of clinically rel-
(20.7 to 28.0) in the meniscectomy group (fig 2). Like- evant differences were: 7.4 for pain, 8.4 for symptoms,
wise, there were no clinically relevant differences 4.1 for activities of daily living, 10.9 for function in sport
between groups in KOOS4 score from baseline to fol- and recreation, and 13.6 for knee related quality of life.
low-ups at 3 and 12 months (fig 2). Clinically comparable improvements were found for all
The results of per protocol and as treated analyses of five KOOS subscales at all time points, with the excep-
between group differences in mean change from base- tion of 12 months, where the meniscectomy group
line to two year follow-up in KOOS4 score were similar reported significantly or clinically relevant better scores
to those of the intention to treat analysis; the difference for knee related quality of life and function in sport and
in the per protocol analysis was 2.2 points (3.7 to 8.0; recreation (see supplementary figure S4). There were no
P=0.47) and in the as treated analysis was 2.0 points clinically relevant differences between the groups in
(4.1 to 8.1; P=0.52), both in favour of the exercise group SF-36. Results for per protocol and as treated analyses
(see supplementary table S1). Supplementary figure S5 were similar to the intention to treat analyses (see sup-
shows the scores for the 13 participants who crossed plementary tables S1 and S2).
over. The exercise group also had significantly greater
Sixty two participants in the exercise group and 64 in improvement in all muscle strength tests at the 12
the meniscectomy group were included in the intention month follow-up (P<0.03). The exercise group had sig-
to treat analysis (fig 1). Both the per protocol and the as nificantly greater improvement in the 6 m timed hop
treated analysis included 34 participants in the exercise test at three months (P=0.02) and 12 months (P=0.04),
group, and 58 and 70 participants in the meniscectomy but not in the one leg hop test or the knee bend test
group, respectively (see supplementary figure S3). (fig4). Results for per protocol and as treated analyses
For ease of interpretation, we also compared the pro- of the knee bend test were in favour of the exercise
portion of participants reporting a clinically relevant group at three months (see supplementary table S2).

Mean difference Mean difference Harms


(95% CI) (95% CI) From baseline to the two year follow-up, no serious
Muscle strength at 3 months
Peak torque flexion (Nm) 7.8 (2.9 to 12.7) adverse events were recorded in either group. During
Total work flexion (J) 49.4 (16.0 to 82.9) the same period, 23% of the participants in each group
Peak torque extension (Nm) 23.3 (14.7 to 31.9) experienced pain, swelling, instability, stiffness, or
Total work extension (J) 110.4 (67.5 to 153.3) decreased range of motion in the index knee that was
Muscle strength at 12 months serious enough to seek consultation. Similar symptoms
Peak torque flexion (Nm) 7.0 (2.1 to 11.9) in the contralateral knee were experienced by 21% of
Total work flexion (J) 37.5 (3.8 to 71.1) participants in the exercise group and 14% in the menis-
Peak torque extension (Nm) 9.4 (0.7 to 18.1) cectomy group.
Total work extension (J) 55.5 (12.3 to 98.6)
-20 0 20 40 60 80 100 120 Discussion
Favours arthroscopic Favours Supervised exercise therapy showed positive effects
partial meniscectomy exercise therapy over arthroscopic partial meniscectomy in improving
Fig 3 | Forest plots of intention to treat analyses of differences between groups in thigh thigh muscle strength, at least in the short term, but not
muscle strength (peak torque (Nm) and total work (J) for knee extension and knee flexion, in patient reported outcomes, where the groups
respectively) at three (primary endpoint) and 12 months reported clinically comparable improvements at two

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Mean difference Mean difference could not be excluded that the surgically treated group
(95% CI) (95% CI)
Performance at 3 months reported a better outcome when evaluated using two
One leg hop test (cm) 4.9 (-1.7 to 11.6) other KOOS subscales: knee related quality of life and
6 m timed hop test (sec) 0.4 (0.1 to 0.7) function in sport and recreation. This finding was, how-
Knee bends 30 sec (n) 1.5 (-1.2 to 4.1) ever, not present at three months or maintained at two
Performance at 12 months years, suggesting it was of short duration.
One leg hop test (cm) 0.1 (-6.7 to 6.9)
6 m timed hop test (sec) 0.4 (0.0 to 0.7) Strengths and limitations of this study
Knee bends 30 sec (n) -1.3 (-4.1 to 1.4) Patient reported outcomes are prone to placebo
-4 -2 0 2 4 6 8 effects.31 Although placebo effects are greater after inva-
Favours arthroscopic Favours sive interventions such as surgery,3132 they are also
partial meniscectomy exercise therapy
present from non-invasive passive treatments such as
Fig 4 | Lower extremity performance tests: one leg hop test (cm), 6 m timed hop test (sec), inactive ultrasonography and inert gel.33 In exercise
and number of knee bends in 30 seconds (n) at three and 12 months. Whiskers represent studies, where the patient, not the therapist, performs
95% confidence intervals the intervention, placebo effects are less obvious,
although attention effects cannot be excluded. Objec-
Mean difference Mean difference tive outcomes are less prone to placebo effects,31 and a
(95% CI) (95% CI) valuable addition for interpretation of clinical trials
KOOS
KOOS4 0.9 (-4.3 to 6.1) comparing surgical interventions with non-surgical
Pain 1.4 (-3.9 to 6.8) interventions. Although we found no significant differ-
Symptoms 5.3 (0.5 to 10.2) ences between treatments when evaluated using
ADL 1.6 (-2.9 to 6.1) patient reported outcomes, muscle strength was signifi-
Sport/Rec -1.5 (-9.1 to 6.2) cantly more improved in the supervised exercise group,
QOL -1.8 (-8.1 to 4.5) directly after the intervention at both three months and
SF-36 12 months. We cannot exclude the possibility that the
PCS -1.5 (-3.9 to 1.0) greater placebo effect from surgery on patient reported
MCS 1.2 (-1.4 to 3.7) outcomes masks a real difference in treatment
-12 -8 -4 0 4 8 12 between groups. It is a limitation of the study that we
Favours Favours did not include a sham surgery group, which would
arthroscopic exercise have been needed to disentangle these mechanisms.
partial therapy
meniscectomy We used muscle strength testing as an objective out-
come. Although muscle strength was immediately
Fig 5 | Forest plots showing intention to treat analyses of
increased and maintained at 12 months in the exercise
between group differences in changes in primary patient
reported outcome (mean score for knee injury and group, it was reduced at three months and only slightly
osteoarthritis outcome score (KOOS) subscales for pain, better than at baseline at 12 months in the surgical
other symptoms, function in sport and recreation, and group. It is reasonable to suggest that this strengthen-
knee related quality of life (KOOS4)), and secondary ing effect of exercise therapy was maintained during
outcomes for KOOS subscales and SF-36 physical the next year, and that measuring strength and func-
component summary (PCS) and mental component tional performance at 12 months instead of two years as
summary (MCS) from baseline to two year follow-up.
planned a priori is not supposed to have an influence on
Whiskers represent 95% confidence intervals. QOL=quality
the results of this trial. Muscle strength is important for
of life; ADL=activities of daily living
physical function, but interestingly the significantly
greater improvement in muscle strength in the exercise
years. Our findings confirm previous studies evaluating group did not translate into consistently better func-
the patient reported effect of surgery in addition to exer- tional performance. Knee extensor weakness is a risk
cise compared with exercise alone.9-1113 In our study, factor for osteoarthritis,34 and longer term follow-up
only 4% of participants had definitive radiographic evi- studies will show if exercise therapy and thigh muscle
dence of osteoarthritis. Thus, our study extends previ- strength have the potential to mediate the high risk of
ous findings to patients with early or no radiographic radiographic osteoarthritis seen in patients with degen-
evidence of osteoarthritis. erative meniscal tears treated with arthroscopic partial
Patient reported secondary outcomes confirmed no meniscectomy.
clinically relevant differences between groups at two The strengths of this study are the randomised con-
years, with the exception of symptoms as measured on trolled trial design, the multiple assessments, the high
the knee injury and osteoarthritis outcome score (KOOS) rate of participation in the two year follow-up, the use
scale, where the exercise group reported significantly of valid and reliable patient reported outcomes, as well
fewer knee symptoms such as swelling, mechanical as inclusion of tests for muscle strength and perfor-
problems, and restricted range of motion. mance2122 and the blinding of the assessors.
One study reported an 8 point and 6 point signifi- In addition to the lack of a sham surgery group, a lim-
cantly better outcome from surgery at three and 12 itation of comparing surgical with non-surgical treat-
months, respectively, as evaluated using the KOOS sub- ment is the possibility of crossover from the
scale for pain.8 In the current study, at 12 months it non-surgical group to the surgical group. Crossover in

thebmj|BMJ 2016;354:i3740|doi: 10.1136/bmj.i3740 7


RESEARCH

our study was based on a clinical evaluation by the ifferences. Supervised exercise therapy showed posi-
d
orthopaedic surgeon, initiated by either the participant tive effects over surgery in improving thigh muscle
or the physiotherapist. We failed to apply a stricter strength, at least in the short term. Nineteen per cent of
approach to determining crossover, such as requiring participants allocated to exercise therapy crossed over
the evaluation of the patients symptoms and knee to surgery during the two year follow-up, with no addi-
related quality of life with a questionnaire that had a tional benefit. No serious adverse events occurred in
preset cut-off score. either group during the two year follow-up. Our results
All analyses were adjusted for baseline values. This is should encourage clinicians and middle aged patients
important because the participants in the meniscec- with degenerative meniscal tear and no radiographic
tomy group had somewhat better KOOS scores at base- evidence of osteoarthritis to consider supervised struc-
line. In addition, the participants were slightly younger, tured exercise therapy as a treatment option.
had a lower body mass index, and reported knee pain We thank the patients for their participation; research coordinators
for a shorter time than the participants randomised to Kristin Blstad and Emilie Jul-Larsen for the organisation of the
participants; physiotherapists Marte Lund, Karin Rydevik, and Christian
exercise therapy. Their better baseline status may have Vilming for assistance with data collection; the Norwegian Sports
provided participants in the meniscectomy group with Medicine Clinic (NIMI), Oslo, Norway, for supporting the Norwegian
an advantage, and, if anything, better results at Research Center for Active Rehabilitation (NAR) with rehabilitation
facilities and research staff (NAR is a collaboration between the
follow-ups would be expected. This, however, was not Norwegian School of Sports Sciences, Department of Orthopaedic
the case. Surgery, Oslo University Hospital, and NIMI); and the Department of
Owing to slow patient flow, the recruitment process Orthopaedic Surgery, Oslo University Hospital and the Department of
Orthopaedic Surgery, Martina Hansens Hospital, Brum, for
was taken over from participant number 54 by a hospi- accessibility to the outpatient and surgical clinics.
tal with a higher patient volume. To ensure consistency Contributors: EMR, MAR, and SS conceived and designed the study.
of recruiting procedures, the two recruiters participated SS, LE, and NJK collected the data. SS trained most participants. LE
in the first six recruiting sessions at the second hospital, and NJK operated on most participants. NJK and EMR drafted the
article. Jonas Ranstam performed the statistical analyses. All authors
and protocols and procedures were thoroughly dis- participated in the analysis and interpretation of the data, revision of
cussed. Likewise, the surgical procedures at both hospi- the article, and final approval of the version to be published. EMR is
tals were discussed among the participating surgeons the guarantor. All authors had full access to all of the data including
statistical reports and tables in the study and take responsibility for
to ensure consistency of protocols and procedures. the integrity of the data and the accuracy of the data analysis.
Importantly, as there was no recruitment in parallel at Funding: This study was funded by Sophies Minde Ortopedi AS,
the two hospitals, participants randomised to either Swedish Rheumatism Association, Swedish Scientific Council, Region
treatment at a given time were drawn from the same of Southern Denmark, Danish Rheumatism Association, and the
Health Region of South-East Norway. The researchers were
pool of patients. Participant characteristics did not dif- independent from the funder.
fer between those included at both sites. For geograph- Competing interests: All authors have completed the ICMJE uniform
ical reasons, participants recruited at the second disclosure form at www.icmje.org/coi_disclosure.pdf (available on
hospital and allocated to exercise therapy were treated request from the corresponding author) and declare: no support from
any company for the submitted work; no relationships with any
at the second physiotherapy clinic. Multiple familiari- company that might have an interest in the submitted work in the
sation sessions were held to ensure that exercise proto- previous three years; their spouses, partners, or children have no
cols were similar at both clinics. financial relationships that may be relevant to the submitted work;
and they have no non-financial interests that may be relevant to the
submitted work.
Comparison with other studies Ethical approval: This study was approved by the regional ethics
Compared with previous studies, our participants were committee of the Health Region of South-East Norway (reference No
younger (mean age 49.6 years),8-13 of a lower body mass 2009/230).
index (26.2),1112 and had fewer radiographic evidence of Data sharing: Anonymised data will be shared on reasonable request.
changes (only 4% had definitive osteoarthritis).811 Transparency: The lead author (NJK) affirms that the manuscript is an
honest, accurate, and transparent account of the study being reported;
Arthroscopic surgery of the knee is considered low that no important aspects of the study have been omitted; and that
risk surgery, the most common serious adverse event any discrepancies from the study as planned have been explained.
being deep vein thrombosis, with 4.13 (95% confidence Data sharing: we agree to share anonymised data upon reasonable
request.
interval 1.78 to 9.60) events per 1000 procedures, fol-
This is an Open Access article distributed in accordance with the
lowed by infection, pulmonary embolism, and death.7 Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license,
No serious adverse events occurred in either treatment which permits others to distribute, remix, adapt, build upon this work
group in our study, indicating that in this comparatively non-commercially, and license their derivative works on different
terms, provided the original work is properly cited and the use is
younger, lower body mass, and more active population, non-commercial. See: http://creativecommons.org/licenses/
both treatments were equally safe. A limitation is that by-nc/3.0/.
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