Oxford

Reference Publication Article

Author Last Name Level of Country Site(s)*
No. Year Weblink
Evidence*

1 Viswanathan, Abd-EL,Barr, Doppenb

2012 n/a n/a USA Single

2 Kocis, Webdsche, Visna 2008 n/a n/a Czech RepubSingle

3 Wang, D. Kim, K. Kim 2008 n/a n/a USA Single

 Treatment Arms Standardized
Most Common
(If comparative Diagnosis/Indication
Study Objective Study Design* Diagnosis/ Indication
study, list all arms) (from IFU of TARGET
(from article)
DEVICE)

To treat spine tumors nn/a n/a Primary Spine and MetIndication 1

To restore vertebral con/a n/a Burst Fracture of fifth Indication 1

To asses the safety andn/a n/a Traumatic Thoracic an Indication 1

 Synthes Target Synthes Target Synthes Target Equivalent
Synthes Target Equivalent
Device - Device - Device - Comparator - Brand
Device - Other Comparator - Other
Brand Name Cement Use Cement Details (e.g. Name
Details Details
(manufacturer)* (Yes/No)* Brand) (manufacturer)*

Synex (Synthes USA

Not reported No Not Reported NR Not Reported

Synex TM (SyntheNot reported No Not Reported NR Not Reported

Synex (Synthes, Pao

Not reported No Not Reported NR Not Reported
 Number of
patients
Number of
Equivalent Equivalent Other Devices Used (received Number of patients
vertebrae
Comparator - Comparator - in Article (not target target (included in Vertebrae
treated
Cement Use Cement Details (e.g. device or equivalent device/equi analysis e.g. at Level*
(Single or
(Yes/No)* Brand) comparator) valent final followup)
Multi)
comparator
)

NR NR X-ray, CT Scan, Ped95 94 MULTI Thoracic-Lumb

NR NR Socon TM, Prolene,1 1 Single Lumbar-Sacral

NR NR X-ray, CT Scan, 28 27 MULTI Thoracic-Lumb

Pedicle Screw
 Mean
Vertebrae Level Mean follow-up
Age Age range Gender/Male Gender/Female
- detials (e.g. Age (Mean) Age (SD) follow-up (months)
range( min) (max) (N) (N)
L1-T1) (months)
(SD)

C7-L4 59 n/a 20 84 65 30 8.1 n/a

L5-S1 25 n/a n/a n/a 1 n/a Not Repor n/a

L1-T12 43 n/a 21 64 19 9 31 n/a

 Visual Visual Visual Visual Maximum Visual Visual Visual
Mean Follow up Analogue Analogue Analogue Analogue Follow-up Analogue Analogue Analogue
follow-up range Scale(VAS) Scale(VAS) Scale(VAS) Scale(VAS) Form VAS Scale(VAS) Scale(VAS) Scale(VAS)
range (min) (max) (pre-op) (pre-op) (pre-op) (pre-op) Post-Op (Post-op) (Post-op) (Post-op)
(months) (months) Scores
Mean SD Min Max (months) Mean SD Min

1 62 6 n/a Not Repor Not Repor Not Repor 2 n/a Not Repor

Not Repor 48 Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor

12 36 Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor
 Change in Change in Change in Change in Maximum
Visual Oswestry Oswestry Oswestry Oswestry
VAS VAS VAS VAS Follow-up
Analogue Disability Disability Disability Disability
for ODI
Scale(VAS) Index(ODI) Index(ODI) Index(ODI) Index(ODI)
(Pre-op - (Pre-op - (Pre-op - (Pre-op - Post-Op
(Post-op) (Pre-op) (Pre-op) (Pre-op) (Pre-op)
Post-op) Post-op) Post-op) Post-op) Measureme
nts
Max Mean SD Min Max
(Mean) (SD) (Min) (Max) (months)

Not Repor 3 n/a Not Repor Not Repor Not Repor n/a Not Repor Not Repor Not Repor

Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor

Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor
 The 36-Item The 36-Item The 36-Item The 36-Item The 36-Item
Short Form Short Form Short Form Short Form Short Form
Oswestry Oswestry Oswestry Oswestry Health Health Health Health Maximum Health
Disability Disability Disability Disability Survey Survey Survey Survey Follow-up Survey
Index(ODI) Index(ODI) Index(ODI) Index(ODI) (SF-36) (SF-36) (SF-36) (SF-36) for SF-36 (SF-36)
(Post-op) (Post-op) (Post-op) (Post-op) Post-Op
MENTAL MENTAL MENTAL MENTAL Measurmen MENTAL
Mean SD Min Max (Pre-op) (Pre-op) (Pre-op) (Pre-op) ts (months) (Post-op)

Mean SD Min Max Mean

Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor

Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor

Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor
The 36-Item The 36-Item The 36-Item The 36-Item The 36-Item The 36-Item The 36-Item The 36-Item The 36-Item
Short Form Short Form Short Form Short Form Short Form Short Form Short Form Short Form Short Form
Health Health Health Health Health Health Health Maximum Health Health
Survey Survey Survey Survey Survey Survey Survey Follow-up Survey Survey
(SF-36) (SF-36) (SF-36) (SF-36) (SF-36) (SF-36) (SF-36) for SF-36 (SF-36) (SF-36)
Post-Op
MENTAL MENTAL MENTAL PHYSICAL PHYSICAL PHYSICAL PHYSICAL Measurmen PHYSICAL PHYSICAL
(Post-op) (Post-op) (Post-op) (Pre-op) (Pre-op) (Pre-op) (Pre-op) ts (months) (Post-op) (Post-op)

SD Min Max Mean SD Min Max Mean SD

Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor

Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor

Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor
The 36-Item The 36-Item
Short Form Short Form
Surgery
Health Health Blood loss
time Surgery Surgery Surgery
Survey Survey (mL) Blood loss Blood loss Blood loss
(minutes) time time time
(SF-36) (SF-36) (mL) (mL) (mL)
(minutes) (minutes) (minutes)
Mean
Mean
PHYSICAL PHYSICAL SD Min Max
SD Min Max
(Post-op) (Post-op) (*: Median)
(*: Median)
Min Max

Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor

Not Repor Not Repor Not Repor Not Repor Not Repor 240mins Not Repor Not Repor Not Repor 2000ml

Not Repor Not Repor 334mins (+,-) 85 240mins 480mins 678ml Not Repor 400ml 2000ml
 Radiation Radiation
Length of Length of Length of Length of exposure exposure
hospital hospital hospital hospital Fusion rate Fusion rate Fusion rate Fusion rate time- time-
stay (days) stay (days) stay (days) stay (days) Patient Patient
Mean SD Min Max (minutes) (minutes)
Mean SD Min Max
Mean SD

Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor

Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor

Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor
 Radiation Radiation Radiation Radiation Other
Radiation Radiation
exposure exposure exposure exposure outcomes
exposure exposure
time- time- time- time- Screw Screw
time- time- Other Comments
Healthcare Healthcare Healthcare Healthcare (including loosening loosening
Patient Patient for Performance
provider provider provider provider information
(minutes) (minutes) Outcomes
(minutes) (minutes) (minutes) (minutes) from different (Number) (%)
follow up time
Min Max
Mean SD Min Max points )

Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not ReportedNot Reported 1 1.05%

Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not ReportedNot Reported Not Repor Not Repor

Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not ReportedNot Reported Not Repor Not Repor
 Other device Other device
Cement Cement Cage Cage Cage Cage Hardware Hardware
-related issues -related issues
leakage leakage migration migration subsidence subsidence breakage breakage
(AE Name and (AE Name and
(Number) (%) (Number) (%) (Number) (%) (Number) (%)
Number) %)

Not Repor Not Repor Not Repor Not Repor 12 12.60% 3 3.16% Not ReportedNot Reported

Not Repor Not Repor Not Repor Not Repor Not Report Not Repor Not Repor Not Repor Not ReportedNot Reported

Not Repor Not Repor 1 3.57% 3 10.72% Not Repor Not Repor Not ReportedNot Reported
Heterotopic Heterotopic
Nonunion Nonunion Malunion Malunion Infection Infection Spondyloli Spondyloli
ossification ossification
sthesis sthesis
(Number) (%) (Number) (%) (Number) (%) (Number) (%)
(Number) (%)

Not reported Not reportedNot reportNot reportNot reportNot report5 5.20% Not reportNot report

Not Reported Not Reporte Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor Not Repor

Not Reported Not Reporte Not Repor Not Repor Not Repor Not Repor 1 3.57% Not Repor Not Repor
 Neurologic Neurologic
al al
Deep Vein Deep Vein CSF CSF Pain
Emboli complicatio complicatio
Emboli (%) Thromboses Thromboses Leakage Leakage
(Number) n n
(Number) (%) (Number) (%) (Number)
(Number) (%)

1 1.05% 3 3.15% 2 2.10% 1 1.05% 3

Not Repor Not Repor Not Reported Not Reported Not Repor Not Repor Not Repor Not Repor Not Repor

Not Repor Not Repor 1 3.57% 2 7.14% 0 0 Not Repor

 Revision Revision
(Device (Device
Re- Re- removal removal Other complications
Pain Death Death
operation operation due to due to Death
complicatio complicatio Details (Number)
(%) (Number) (%)
(Number) (%) ns) ns)

(Number) (%)

3.15% 2 2.10% 0 0 1 1.10% From PulmNot Reported

Not Repor Not Repor Not Repor 0 0 0 0 0 Not Reported

Not Repor 1 3.57% 0 0 2 7.14% Acute Resp1

Other Other Complication
complications complications comments (elaborate
Strengths/L
on any complications Harm
imitations
( %) ( %) to aid in discussion in
CER write-up)

Not Reported Not Reported Not Reported Not Reported n/a

Not Reported Not Reported Not Reported Not Reported n/a

3.57% 25.00% Wound Dehiscence (n=1

Not Reported n/a
Information on the
other arms that may Notes
help CER Write-up.

QC REVIEWER
QC REVIEWER DATE
n/a n/a

n/a n/a

n/a n/a
Multi I Prospective single arm cohort Syncage (Synthes) Yes
Single II Prospective single arm case series NR No
NR III Prospective comparative cohort NR
IV Prospective comparative case series
Retrospective single arm cohort
Retrospective single arm case series
Retrospective comparative cohort
Retrospective comparative case series
Randomized controlled trial (RCT)
Cervical Target DevEquivalentIndication 1
Thoracic NR EquivalentIndication 2
Lumbar EquivalentIndication 3
Sacral NR Indication 4
Cervical-Thoracic Indication 5
Thoracic-Lumbar Indication 6
Lumbar-Sacral Indication 7
NR