Elevatemotion
180°
145°
120°
90°
60°
30°
0°
Introducing the
InSpace balloon implant
A minimally-invasive biodegradable, subacromial spacer for
arthroscopic treatment of massive, irreparable rotator cuff tears
Clinically proven
Safety results
MRI findings
• Similar rates of Subsequent Secondary Surgical
Intervention (SSSI) through 24 months (InSpace: 4;
Partial repair: 3).
U.S. Pivotal Study:
Clinical safety and effectiveness evidence1
• Balloon biodegrades over approximately one year
— 94% of study patients demonstrated no balloon
residuals at one year.
• No InSpace devices required explanation.
• No subject had a Serious Adverse Device Effect
(SADE) through the entire 24 months of the study.
Study design: A prospective, single-blinded, multi-center, randomized, controlled, pivotal study to assess
the safety and effectiveness of the InSpace device, compared to arthroscopic partial repair, for treatment of
full thickness massive rotator cuff tears (MRCT).
• A subset of InSpace subjects (n=32) received Week
6 MRIs. Of those subjects with suspected implant
deflation (n=4) or displacement (n=5), the radiologic
findings did not appear to be correlated with clinical
concerns of safety or effectiveness.
• InSpace had a greater number of Adverse Events
of the Index Shoulder (AEs) compared to Partial
Repair (InSpace: 45; Partial Repair: 30). Notably,
most were mild/moderate events (93%), and none
were device-related.
Purpose: To evaluate the safety and effectiveness of the InSpace implant as the primary
surgical treatment for full thickness massive irreparable rotator tears (MRCT).
See the package insert for complete summary
of clinical safety and effectiveness data.
Findings
High rates of clinical success, defined as meeting the study
primary endpoint, in the InSpace study group at 24 months
(InSpace: 87.8%, Partial repair 88.1%) (Table 1)
Early improvement compared to baseline noted at 6 weeks in Patient
Reported Outcomes (PROs) of ASES, WORC, Constant (Figures 1–3)
InSpace
Table 1. Primary composite endpoint — Subjects ≥65 years of age
WORC improvement ≥275 at month 24 and ASES improvement ≥6.4 at
month 24 with no Subsequent Secondary Surgical Interventions (SSSI) and
no Serious Adverse Device Effects (SADEs) through month 24
Partial repair
*
55
-50
45
-250
55
55
35
Mo 12
45
Mo 24
Mo 6
Analyzed subgroup population
InSpace
% (n/N)
InSpace
Difference
(%)
25
15
15
5
5
Partial Repair
Wk 12
Wk 6
Subjects ≥65
years of age
88.1 (37/42)
-0.3
95% CI
(74.4, 93.9)
(73.4, 94.4)
(-21.0, 8.6)
P-value for
non-inferiority
(10% margin)
—
—
0.01
Note 1: Results from logistic regression model with Firth correction
Note 2. Per protocol population
-5
Day 10
*
Mo 6
25
Mo 12
InSpace
Partial Repair
Mo 24
Mo 12
-5
-5
5-
Month 12
Month 24
Time Post-operatively
Figure 1. Mean ASES scores —
change from baseline
Mean ASES overall scores presented
as a change from baseline for the
InSpace (N = 93) and Partial repair (N
= 91) Intent to Treat (ITT) Population.
ASES = American Shoulder and Elbow
Score, possible range: 0–100 (higher
score = improvement). No statistically
significant differences were found
between groups. Error bars indicate
95% confidence intervals (unpaired
t-test, *, p ≤0.05). ITT population.
Day 10
-1250
Week 12 Month 6
Month 12
Month 24
Time Post-operatively
Figure 2. Mean WORC scores —
change from baseline
Mean WORC index presented as a
change from baseline for the InSpace
(N = 93) and Partial repair (N = 91)
Intent to Treat (ITT) population.
Western Ontario rotator cuff index,
possible range: 0–2100 (lower score =
improvement). A statistically significant
difference was found between groups
at day 10. Error bars indicate 95%
confidence intervals (unpaired t-test, *,
p ≤0.05). ITT population.
Day 10
-15
Mo 24
-2535
5
2
-5015
Wk 12
Week 6 Week 12 Month 6
5
-75
Month 12
Mo 6
5
4
Mo 6
*
5
5
*
0
5
2
515
*
*
5
5
4
1535
35
-650
50
25
5
25
Wk 12
-1050
Day 10 Week 6 Week 12 Month 6
87.8 (43/49)
Wk 6
Week 6
-450
35
-850
15
-5
—
Day 10
45
35
25
Partial
repair
% (n/N)
Early return to range of
motion that is maintained
out to 24 months (Figure 4)
Month 24
Wk 6
Time Post-operatively
Figure 3. Mean overall constant
scores — change from baseline
Mean overall constant score presented
as a change from baseline for the
InSpace (N = 93) and Partial Repair (N
= 91) Intent to Treat (ITT) population.
Constant score possible range: 0–100
(higher score = improvement). No data
available for day 10. A statistically
significant difference was found between
groups at week 6 and month 24. Error
bars indicate 95% confidence intervals
(unpaired t-test, *, p ≤0.05). ITT
population.
Day 10
-100
Mo 12
Wk 12
Mo 24
InSpace
*
Partial Repair
Wk 6
Week 6 Week 12 Month 6
Month 12
Month 24
Day 10
Time Post-operatively
Figure 4. Mean ROM forward elevation
scores — change from baseline
Mean ROM forward elevation scores
presented as a change from baseline for
the InSpace (N = 93) and Partial pepair
(N = 91) Intent to Treat (ITT) population.
Statistically significant differences were
found between groups at day 10 (p=0.041),
week 6 (p=0.0001), month 12 (p=0.0048)
and month 24 (p=0.003). Error bars indicate
95% confidence intervals (unpaired t-test,
*, p ≤0.05). ITT population.
Who it’s for
Successful results begin with patient selection
• ≥65 years of age whose clinical
condition would benefit from
treatment with a shorter surgical
time compared to partial repair
• Massive, irreparable, full thickness
RCT measuring ≥5cm in diameter
and involving at least two tendons
• Mild to moderate glenohumeral
osteoarthritis, with no evidence
of significant osteoarthritis or
cartilage damage in the shoulder
• Functional deltoid muscle and
preserved range of motion on
physical examination
• No evidence of significant
glenohumeral instability
• No evidence of missing or
nonintact coracoacromial ligament
• No known neurovascular
compromise
• No known blood coagulation
disorders, compromised immune
systems, severe chronic diseases
such as heart failure, cirrhosis
and/or severe liver dysfunction,
chronic renal failure or any
other conditions that would
compromise healing
See the package insert for complete
indications, contraindications,
warnings, precautions and
instructions for use.
Small (0130), medium (0131)
and large (0132) sizes
to suit patient anatomy
Made of poly
(L-lactide-co-ɛ-caprolactone)
a biodegradable polymer
Not made with
natural rubber latex
or phthalates
InSpace balloon implant
is supplied sterile (sterilized by EtO)
and intended for single use
1250
C OPYRIGHT 2022 T HE AUTHORS . P UBLISHED BY THE J OURNAL OF B ONE AND J OINT S URGERY, I NCORPORATED. A LL RIGHTS RESERVED
A commentary by Rony-Orijit Dey Hazra,
MD, et. al, is linked to the online version of
this article.
1251
InSpace Implant Compared with Partial Repair
for the Treatment
treatment algorithm of Full-Thickness Massive
1252
why decision-makingfor massive rotator cuff tears may
explain
around the manageme
‡2 tendons involved
remains soRotator
nt of
Cuff Tears
challenging
. Savarese and Romeo these patients
resonance imaging as determined on preoperative
surgical technique
magnetic
THE JOURNAL
OF BONE &
JOINT SURGER
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V O LU M E 1 04-A
N U M B E R 14 J
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THE JOU
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V O LU M E
I N S PA C E I M P L
A N T O R PA R
T I A L R E PA I
F U L L -T H I C K N
R F O R T R E AT
ESS MASSIV
MENT OF
E R O TAT O R
CUFF TEARS
F BONE
& JOINT
SU RG E RY
1 04-A N
JBJS.OR
UMBER
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14 J U LY
20, 2 022
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2,11,12
using the InSpace
InSpace Implant Compared with Partial Repair for the
Treatment of Full-Thickness Massive Rotator Cuff Tears
d
12
described a
I N S PA C E
I
MPLAN
T
[MRI]
F U L L -Tscans)
HI
wereO R P A R T I A L
R E PA I R F
they met the inclusion
KNES
implant (Stryker) Controlled
treatment option
M Ascreened
OR TRE
S S I V E R to determine
A Multicenter,
Single-Blinded,
Trial
as a novel
or exclusionS criteria
if AT M E N T O F
for patients withRandomized
O TAT O
(Table
R CU
irreparable
cuff
C
I). Prior to randomiza
by the investigato
FF TEA
tears2. The implant
r RS
tion, subjects were
is deployed arthroscopmassive rotator
sex, with blocking
subacromial space
into
Nikhil Verma, MD, Uma Srikumaran,
MD, MBA, MPH, Colleen M.ically
Roden,
MSc,
J. Rogusky, MD,by site, to ensure a within-stra stratified by
and
theEdwin
subject
between the humeral is designed to act as a temporary
distribution between
tum-balanced
Peter Lapner, MD, FRCSC, Heather
Neill, RN,
A. Abboud, MD, onspacer
behalf ofvidual
the SPACE GROUP*
headand
andJoseph
the acromion,
gliding during articulatio
independent of the the 2 treatment groups. An indienabling smooth
study team developed
n and reducing acromiohu
zation schedule,
tact pressure while
the randomiusing a random
meral conrestoring a more
block size of 2 or
13
position
anatomic
4 (Fig. 1).
. The was
tive balloon
of this study
to prospectively
theglenohum
efficacy and
of aIntraopera
subacromial
Background: The purpose
eligibility criteria
implant
eral safety
has been usedevaluate
the arthroscopic
were confirmed
with numerous
clinically
surgery. Subjects
forin>10
spacer (InSpace implant; Stryker)
compared
with arthroscopic
partial
repair
patients
posterosuperior
during
publication
years,with irreparable,
s
demonstra
were
terosuperi
included
ting decreased operative
or, massive rotator
massive rotator cuff tears.time, decreased surgical complexity
cuff tear was amenableif the posrepair (adequate
, and the ability to
rehabilitation, resulting
tissueand
acceleratemassive
quality
Methods: Patients ‡40 years
of age with symptomatic,
irreparable,
posterosuperior,
rotator
tears
an to restore the force to partial
in more
could
rapid patient
not becuff
However,
completely repaired,
couple) but
14,15
to failed
our knowledge
intact subscapularis whopreviously
underwent
nonoperative
management wererecovery
included
in
randomized
controlled trial
. thisand
, no randomize
the subscapularis
severe glenohum
d controlled trial
was intact,
eral arthritis (Internatio
its efficacy
comparing the InSpace implant withevaluated
partial repair.
Clinical
through a 24-month
has at baseline
Society [ICRS]
andoutcome
safety. data were collected
nal Cartilage Repair
Grade
purpose
3 or The
higher) was not present.
of this in
follow-up. The primary outcomeThe
was
improvement
the American Shoulder and Elbow Surgeons
scores.
multicente
jects were (ASES)
trial
r, randomize controlled
electronica
Eligible subto evaluate
lly analog
randomized intraopera
secondary outcomes includedwas
change
from baseline
in the Western OntariodRotator
Cuff (WORC)
the visual
the
receivescore,
(Stryker) compared efficacy and safety of the InSpace
the InSpace implant
tively
scale (VAS) pain score, the Constant-Murley
shoulder
score, the EuroQol-5 Dimensions-5-Level
score, active
without partial repair 1:1 to either
with partial
group)(EQ-5D-5L)
repair as a primary implant
treatment forComplications
or undergo partial
posterosuperior,
range of motion, and operative time.
and reoperations
group werewere
also recorded.
repair (the control (the treatment
massive rotatorfor eachsurgical
blinded to their treatment
hypothesized that
group). Subjects
cuff
tears.
the functional
We partial repair
Results: Twenty sites randomized
184 patients:
93 in the
group and 91 in the
Significant andassignment throughout
andInSpace
Thegroup.
patient-rep
following InSpace
implant
the study.
orted outcomes
is a biodegrad able
arthroplast
clinically relevant improvements
in the ASESimplant
score from
baseline
in both groups at L-lactide-c
Month 12 o-e-caprol
and were maintained
balloon spacer
those following
y were
wouldnoted
be equivalent to
actone
(poly
partial
[PLCL])
repair,
at Month 24. Overall, 83% of patients in the InSpace group
81% of patients in the partial solution
repair group
ASES
with aand
inflated with
shorter
to a achieved
predetermithe
operative time.
ned
volume after positioning sterile saline
minimally clinically important
difference threshold, and 82% of patients in the InSpace
group and
79%space,
of patients in the
partial
cromial
Materials
and 1 of 3 sizes is
in
andclinical
Methods
repair group achieved the substantial
benefit threshold. Forward elevation was significantly
in the InSpace selected on the basis the subaoperative greater
measureme
rior to study initiation,
ntMonth
(Fig. 2).
group compared with the partial repair
group at Day 1020
(p =enrolling
0.04), Week 6 (p = 0.0001), Month
(p = 0.005), and
24 Implant resorption of the intra1212
months.
States and Canada
No rotator cuff repair
sites in group
occurs over
the United
(p = 0.003). The operative time was
shorterinstitution
in the InSpace
(p < 0.0001).
device-related
surgical was performed
received
group.No
approval. Thissignificantly
Patients randomize
in the InSpace
al and
review
studyafter
d
complications were noted, and 4 reoperations
implantation
3 reoperations
after partial repair
were required.
board
wasInSpace
registered
anchor
(NCT02493660).
repair (the best possible to partial repair underwent suture
Patients with posterosup at ClinicalTrials.gov
repair as determined
surgeon)
Conclusions: The InSpace
implant
is
an
appropriate
alternative
to
partial
repair
in
patients
with
irreparable
posterocuff tears
of the posterosuperior
by
erior, massive rotator
(defined tears
rotator cuff. Additional the operating
of subscapularis.
‡5 cm at Fig.
procedures
superior massive rotator cuff tears and as
an intact
Notable benefits include
early functional
recovery and
the1tendon
were recorded
concomitant
insertion and
Flowchart
documented included for both groups. The intraoperat
pain relief combined with a shorter operative time.
of patient
ive times
total operative time,
s. PR = partial
skin incision to
closure
TABLE I Key
repair and of levels of evidence.
Level of Evidence: Therapeutic
Level
I. See
Instructions for Authors for a complete
description
, and
Inclusion
skin
M24 = Month
andtime
Exclusion
for implan
Criteria
was standar
24.
dized in both t placement. Postop
Inclusion
erative rehabil
groups (Table
Criteria
Follow
itation
Months 3, -up visits completed II).
level success
1. Male or female
6,‡40
12,years
thatmassive
Exclusionfor
espite successful results
for both
conservative
options at
other
joint replacement
painful,
subject
andand
Daythan
was constru
Criteria
24age
of compl
10,total
(chang
includ
of
2. Within 9 months
Week 6,
e from baselin
cted
ed
1. Known
ication
should
before
and severe
operative treatment for
partial-thickness,
small,
and ations,
rotator
cuffallergy
tears
intopatients
without
glenohumeral
arthritis
s,enrollment,
study
er examin
reoper
the implant
16-18
e of ‡275 to include 2 efficacy
and
ASES)
positive diagnostic
material (poly
ations;
poly
1-3 collect
2,4-10
L-lactide
for
,
and
ion
measu
L-lactide-coimaging
a
review
the WORC
[PLA] and. e-caprolacto
concom
medium-sized rotatorindex
cuffshoulder
tears
controversial
, surgical of
treatment
The lack of advers
a universallysafety
accepted a
bypatien
e-caprolacto
MRI oft-repo
the remain
clinica
itant medic
2. Evidence of the
and ‡6.4 for res
re (absen
copolymer of
l researcahfull-thicknes
indicating
e event), and measune,
rted
outcomes following
ations; ne)
ce of a devicecoordinator.
the
conditions:
massive rotator
s
avoidance
was condu
by an indepe
procedure;
a. Severe glenohumer
cuff cted
related serious
The
of
should
a
each
subseq
ndent
al
*A list of the SPACE GROUP members
is included in a tear:
note atbythe
end
of
the
article.
or
a. Measuring
acromiohum
compo
er physical
an investigator b. Full-thicknes
uent second
and‡5includ
eral
to bearthritis
nent was
cm in diameter
maintained
examin
s cartilage
(Cofield
not
ed a goniom
loss
ation
classification)
as seen on MRI
through Month required to be met ary surgical
c. blinded
motioof
orto
etric measu
treatm
posterior
Disclosure: The Disclosure of Potential
Conflicts
forms are provided
with Anterior
the online
version
of shoulder
the article (http://links.lww.com/JBJS/H35).
n Interest
in forwar
ent
b. Involving
24. The compo at Week 6 and
group
subluxation or dislocation
remenwithin
‡2 tendons
history
d elevation,
t of the
site end point
active
previous
side, and intern
according
3. Functionalthe
extern
d. Preexisting
deltoid
al rotationdeltoid range5 years,
was
of examination, or radiographic to the patient
muscle
A data-sharing statement is provided withas
the
online
version
of preserved
the
article (http://links.lww.com/JBJS/H37).
al rotatio
and
isomet
with defect
passive range
or deltoid palsy
findings
n reachi
ric streng
e. Major
of motion
arm
ng
joint trauma, the
at
on
behind
th
physical
testing
infection,
elevati
the back,
or necrosis
withSurgery,
f. arm
Copyright 2022 The Authors. examination
Published by theon
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reserved.
This is an open-access article
Partial-thick
in theofscapul
the
as well
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ar plane using
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g. Fully
d VAS
Creative Commons
Attribution-Non
Derivatives
4.0
(CCBY-NC-ND),
where it is permissible to
distributed under the terms of4.the
at tears
The
90 forwar
pain
reparabledLicense
primar
scorey>30 mmCommercial-No
rotator
ain handh
5. Underwent
cuff teard(tear
outcom
eld
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