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Evidence in focus Clinical summaries Clinical evidence summaries on VISIONAIRE Cutting Guides Supporting healthcare professionals Supporting healthcare VISIONAIRECutting Guides

Evidence in focus...Kosse NM, 2018 Stability and alignment do not improve by using patient-specific instrumentation in total knee arthroplasty: a randomized controlled trial 8 Marimuthu

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Page 1: Evidence in focus...Kosse NM, 2018 Stability and alignment do not improve by using patient-specific instrumentation in total knee arthroplasty: a randomized controlled trial 8 Marimuthu

Supporting healthcare professionals

Supporting healthcare professionals for over 150 yearsNAVIO™Surgical System

Supporting healthcare professionals for over 150 years

Evidence in focusClinical summaries

Clinical evidence summaries on VISIONAIRE Cutting Guides

Supporting healthcare professionals

Supporting healthcare professionals for over 150 yearsVISIONAIRE™Cutting Guides

Page 2: Evidence in focus...Kosse NM, 2018 Stability and alignment do not improve by using patient-specific instrumentation in total knee arthroplasty: a randomized controlled trial 8 Marimuthu

Purpose

To summarise the clinical studies aligned with the VISIONAIRE Cutting Guides (Smith & Nephew Memphis, TN, USA) meta-analysis.1

Clinical summaries

VISIONAIRE™ Cutting Guides

19

studies reporting on VISIONAIRE meta-analysis study outcomes of interest1

59

studies reporting on VISIONAIRE1

Studies

Author/year Study titleStudy outcomes aligned with meta-analysis*

Page number

Abane L, 2015 A comparison of patient-specific and conventional instrumentation for total knee arthroplasty 4

Bali K, 2012 Custom-fit total knee arthroplasty: our initial experience in 32 knees 4

Barke S, 2013 Patient-matched total knee arthroplasty: does it offer any clinical advantages? 5

Daniilidis K and Tibesku CO, 2014

A comparison of conventional and patient-specific instruments in total knee arthroplasty 5

DeHaan AM, 2014Patient-specific versus conventional instrumentation for total knee arthroplasty: peri-operative and cost differences

6

Heyse TJ and Tibesku CO, 2014

Improved femoral component rotation in TKA using patient-specific instrumentation 7

Huijbregts HJ, 2016

Component alignment and clinical outcome following total knee arthroplasty: a randomised controlled trial comparing an intramedullary alignment system with patient-specific instrumentation

7

Kosse NM, 2018Stability and alignment do not improve by using patient-specific instrumentation in total knee arthroplasty: a randomized controlled trial

8

Marimuthu K, 2014

A multi-planar CT-based comparative analysis of patient-specific cutting guides with conventional instrumentation in total knee arthroplasty

8

Moubarak H and Brilhault J, 2014

Contribution of patient-specific cutting guides to lower limb alignment for total knee arthroplasty 9

Key: Study outcomes

Efficiency Accuracy

Patient outcomes

Evidence in focus

page 2 of 16

Page 3: Evidence in focus...Kosse NM, 2018 Stability and alignment do not improve by using patient-specific instrumentation in total knee arthroplasty: a randomized controlled trial 8 Marimuthu

Studies

Author/year Study titleStudy outcomes aligned with meta-analysis*

Page number

Myers K, 2014An evaluation of the need for blood transfusion when using patient specific instrumentation for total knee arthroplasty

9

Nankivell M, 2015 Operative efficiency and accuracy of patient-specific cutting guides in total knee replacement 10

Noble JW Jr, 2012 The value of patient-matched instrumentation in total knee arthroplasty 10

Pfitzner T, 2014Small improvements in mechanical axis alignment achieved with MRI versus CT-based patient-specific instruments in TKA: a randomized clinical trial

11

Predescu V, 2017 Patient specific instrumentation versus conventional knee arthroplasty: comparative study 11

Rathod PA, 2015 Reducing blood loss in bilateral total knee arthroplasty with patient-specific instrumentation 12

Tammachote N, 2018

Comparison of customized cutting block and conventional cutting instrument in total knee arthroplasty: a randomized controlled trial

12

Vide J, 2017Patient-specific instrumentation in total knee arthroplasty: simpler, faster and more accurate than standard instrumentation – a randomized controlled trial

13

Vundelinckx BJ, 2013

Functional and radiographic short-term outcome evaluation of the VISIONAIRE system, a patient-matched instrumentation system for total knee arthroplasty

13

AbbreviationsTKA: total knee arthroplastyHKA: hip-knee-ankle angle KSS: Knee Society Score

*Studies may include other study outcomes.

CAS: computer-assisted surgery Hb: haemoglobin

page 3 of 16

Page 4: Evidence in focus...Kosse NM, 2018 Stability and alignment do not improve by using patient-specific instrumentation in total knee arthroplasty: a randomized controlled trial 8 Marimuthu

Study design

• Prospective, randomised study evaluating coronal HKA alignment, assessed radiographically 3 months post primary TKA

• Procedures were performed by six surgeons using VISIONAIRE™ (n = 59) or conventional instrumentation (n = 67)

Key results

Accuracy

• Post-TKA HKA alignment at or within 3° of the planned mechanical axis alignment was achieved in the majority of cases with VISIONAIRE (67.8%) or conventional instrumentation (67.2%) (Figure)

Conclusion

VISIONAIRE provided good implant position accuracy comparable to conventional instrumentation.

Study design

• Prospective study evaluating coronal mechanical axis alignment, assessed radiographically 6 weeks post TKA using VISIONAIRE (n = 32)

• Ten patients had prior TKA on the other leg using conventional technique (n=4) or computer-asssisted surgery (CAS; n=6)

Key results

Accuracy

• Post-TKA coronal mechanical axis alignment within 3° of neutral was achieved in 90.6% (29/32) cases using VISIONAIRE, but only 70.0% (7/10) of prior TKA cases with conventional or CAS (Figure)

Conclusion

VISIONAIRE achieved a high level of implant position accuracy.

A comparison of patient-specific and conventional instrumentation for total knee arthroplasty2

Abane L, et al. Bone Joint J. 2015;97-B:56–63.

Custom-fit total knee arthroplasty: our initial experience in 32 knees3

Bali K, et al. J Arthroplasty. 2012;27:1149–1154.

Accuracy

Accuracy

Figure. Mechanical axis alignment

67.8%32.2%

of VISIONAIRE cases within 3° of the

planned mechanical axis alignment

0

20

40

60

80

100

Perc

enta

ge o

f cas

es w

ith m

echa

nica

l axi

s al

ignm

ent w

ithin

of n

eutra

l (%

)

90.6%

70.0%

Figure. Mechanical axis alignment

VISIONAIRE Conventional/CAS

≤3° >3°

page 4 of 16

Page 5: Evidence in focus...Kosse NM, 2018 Stability and alignment do not improve by using patient-specific instrumentation in total knee arthroplasty: a randomized controlled trial 8 Marimuthu

Study design

• Retrospective review of radiographic HKA alignment 3.5 months post-TKA

• Procedures were performed by a single surgeon using VISIONAIRE (n = 150) or conventional instrumentation (n = 156)

Key results

Accuracy

• Post-TKA HKA alignment within 3° of 180° was achieved in significantly more cases with VISIONAIRE than conventional instrumentation (90.7% vs 78.8%; p = 0.003; Figure)

Efficiency

• Mean operative time was 51 minutes using VISIONAIRE or conventional instrumentation

Conclusion

VISIONAIRE demonstrated significantly improved mechanical axis alignment compared to conventional instrumentation.

0

50

60

70

80

90

100

90.7%

78.8%

Perc

enta

ge o

f cas

es w

ith m

echa

nica

l ax

is a

lignm

ent w

ithin

or 18

0° (%

)

Figure. Frequency of post-TKA HKA alignment within 3° of 180°

p=0.003

Study design

• Retrospective review of TKA performed by a single surgeon using VISIONAIRE™ (n=39) or conventional instrumentation (n = 50) during the same period

• Postoperative component alignment, measured radiographically, and perioperative outcomes were compared

Key results

Patient outcomes

• VISIONAIRE resulted in a mean length of stay of 5.74 days compared to 6.72 days for conventional TKA (Figure)

Efficiency

• VISIONAIRE resulted in a mean operating time of 74.4 minutes compared to 75.3 minutes for conventional TKA

Conclusion

VISIONAIRE demonstrated a mean reduction in hospital length of stay of almost one day compared to conventional instrumentation.

Patient-matched total knee arthroplasty: does it offer any clinical advantages?4

Barke S, et al. Acta Orthop Belg. 2013;79:308–311.

A comparison of conventional and patient-specific instruments in total knee arthroplasty5

Daniilidis K and Tibesku CO. Int Orthop. 2014;38:503–508.

Figure. Comparison of mean number of days spent in hospital

MTWTFSS

VISIONAIRE

5.74mean number of days

Conventional

6.72mean number of days

WEEK 1 4.6% time

reduction (0.98

fewer days)

VISIONAIRE

5.74mean number of days

Conventional

6.72mean number of days

VISIONAIRE Conventional

Efficiency

Patient outcomes

Efficiency Accuracy

page 5 of 16

Page 6: Evidence in focus...Kosse NM, 2018 Stability and alignment do not improve by using patient-specific instrumentation in total knee arthroplasty: a randomized controlled trial 8 Marimuthu

Study design

• Retrospective review of TKA performed by a single surgeon using VISIONAIRE™ (n = 306) or conventional instrumentation (n = 50) during the same period

• Operating room time and turnover, and operative complication frequency were compared

Key results

Efficiency

• VISIONAIRE resulted in a significantly shorter mean operating room time (20.4 minutes less) compared to conventional TKA, (86.8 vs 107.2 minutes; p<0.01) resulting in a cost saving of $1,326/case (Figure)

• Reduced use of surgical trays saved $240 per case with VISIONAIRE versus conventional TKA (Figure)

• VISIONAIRE also significantly reduced mean operating room turnover time by 42% (15.2 vs 21.6 minutes; p = 0.022), providing additional cost savings compared to conventional TKA

• Tourniquet time was reduced by 19.9 minutes with VISIONAIRE compared to conventional TKA (63.3 vs 83.2 minutes; p=0.024)

Patient outcomes

• No significant difference in operative blood loss between VISIONAIRE and conventional TKA (120.8 and 116.7ml, respectively)

Conclusion

VISIONAIRE significantly reduced operating room time and turnover by a combined mean time of 26.8 minutes, resulting in cost savings of more than $1,500 per case compared to conventional TKA.

Patient-specific versus conventional instrumentation for total knee arthroplasty: peri-operative and cost differences6

DeHaan AM, et al. J Arthroplasty. 2014;29:2065–2069.

Figure. Reduction in operating time and cost with VISIONAIRE compared to conventional TKA

Per case savings

26.8 minsmean combined

reduction in operating room

time andturnover

Cost saving$1,566 per case

$1,326 operating room time savings

$240 instrument tray savings

Efficiency

Patient outcomes

page 6 of 16

Page 7: Evidence in focus...Kosse NM, 2018 Stability and alignment do not improve by using patient-specific instrumentation in total knee arthroplasty: a randomized controlled trial 8 Marimuthu

Study design

• Retrospective analysis of femoral component rotation, assessed using magnetic resonance imaging approximately 6 months post-TKA

• A single surgeon performed the procedures using VISIONAIRE™ (n = 46) or conventional instrumentation (n = 48)

Key results

Accuracy

• There were significantly fewer outliers >3° in the VISIONAIRE group compared to conventional instrumentation (2.2 vs 22.9%; p = 0.003; Figure)

Conclusion

VISIONAIRE significantly improved femoral component rotation compared to conventional instrumentation.

Improved femoral component rotation in TKA using patient-specific instrumentation8

Heyse TJ and Tibesku CO. Knee. 2014;21:268–271.

Figure. Frequency of post-TKA femoral external rotation >3° of optimal alignment

0

5

10

15

20

25 p=0.003

22.9%

2.2%

Study design

• Prospective, randomised study evaluating HKA alignment by computed tomography scan approximately 6 weeks post-TKA

• Procedures were performed by two surgeons using VISIONAIRE (n = 69) or conventional instrumentation (n = 64)

Key results

Patient outcomes

• At 3 months post-TKA, 12 complications were reported for VISIONAIRE and 18 were reported for conventional instrumentation

Efficiency

• Mean operative time was 49.8 minutes for VISIONAIRE and 52.3 minutes for conventional instrumentation (Figure)

Conclusion

VISIONAIRE has a mean operative time of approximately 50 minutes, with fewer complications reported at 3 months post TKA.

Component alignment and clinical outcome following total knee arthroplasty: a randomised controlled trial comparing an intramedullary alignment system with patient-specific instrumentation9

Huijbregts HJ, et al. Bone Joint J. 2016;98-B:1043–1049.

Figure. Mean operative time for VISIONAIRE TKA

49.8 mins mean

operative time

VISIONAIRE Conventional

Freq

uenc

y of

pos

t-TK

A fe

mor

al

exte

rnal

rota

tion

>3°

(%)

Accuracy

Efficiency

Patient outcomes

page 7 of 16

Page 8: Evidence in focus...Kosse NM, 2018 Stability and alignment do not improve by using patient-specific instrumentation in total knee arthroplasty: a randomized controlled trial 8 Marimuthu

Study design

• Prospective, randomised study evaluating stability and alignment radiographically 12 months post-TKA

• Procedures were performed by three surgeons using VISIONAIRE™ (n = 21) or conventional instrumentation (n = 21)

Key results

Patient outcomes

• No reoperations were performed (Figure)

− Four adverse events were reported in both the VISIONAIRE group and in the conventional group

Efficiency

• Mean operative time was 66 minutes for VISIONAIRE compared to 68 minutes for conventional TKA

Conclusion

VISIONAIRE achieved a reduced mean operative time compared to conventional TKA, with no reoperations at 12 months post-TKA.

Study design

• Retrospective analysis of implant alignment and component rotation post-TKA, assessed using computed tomography

• Two surgeons performed the procedures using VISIONAIRE (n = 115) or conventional instrumentation (n = 185)

Key results

Accuracy• Mean post-TKA HKA alignment within 3° of neutral was achieved in

the vast majority of cases with VISIONAIRE (86.1%) or conventional instruments (83.2%) (Figure)

Efficiency • Mean operative time was reported as 72.5 minutes for VISIONAIRE and

75.0 minutes for conventional TKA

• Mean tourniquet time was reported as 13.5 minutes for VISIONAIRE and 13.1 minutes for conventional TKA

Conclusion

VISIONAIRE provided accurate implant alignment, comparable to conventional instrumentation.

Stability and alignment do not improve by using patient-specific instrumentation in total knee arthroplasty: a randomized controlled trial10

Kosse NM, et al. Knee Surg Sports Traumatol Arthrosc. 2018;26:1792–1799.

A multi-planar CT-based comparative analysis of patient-specific cutting guides with conventional instrumentation in total knee arthroplasty11

Marimuthu K, et al. J Arthroplasty. 2014;28:1138–1142.

Figure. Mechanical axis alignment

86.1% of VISIONAIRE caseswithin 3° of neutral

13.9%

Figure. Reoperations following VISIONAIRE TKA

0reoperations

Efficiency

Patient outcomes

Efficiency Accuracy

≤3° >3°

page 8 of 16

Page 9: Evidence in focus...Kosse NM, 2018 Stability and alignment do not improve by using patient-specific instrumentation in total knee arthroplasty: a randomized controlled trial 8 Marimuthu

Study design

• Retrospective review of complications and operative outcomes for TKA procedures performed by a single surgeon using VISIONAIRE (n = 21) or conventional instrumentation (n = 24)

Key results

Patient outcomes• Mean length of hospital stay (bilateral TKA) was significantly

shorter (18.4%) with VISIONAIRE versus conventional instrumentation (3.1 vs 3.8 days; p = 0.01; Figure)

• Postoperative blood transfusion was not required in any VISIONAIRE patients, but was required by five conventional TKA patients

• One patient experienced a complication with VISIONAIRE, compared to three patients with conventional TKA

Efficiency• Mean operative time per knee (unilateral TKA) was significantly

shorter with VISIONAIRE versus conventional instrumentation (89.6 vs 116.1 minutes; p < 0.01; Figure)

• Mean tourniquet time (unilateral TKA) was signficantly shorter with VISIONAIRE versus conventional instrumentation (57.6 vs 91.8 minutes; p<0.01)

ConclusionVISIONAIRE significantly reduced operative time, tourniquet time and length of hospital stay, compared to conventional instrumentation.

Study design

• Prospective, observational study evaluating implant alignment radiographically more than 3 months post-TKA

• Procedures were performed by multiple surgeons using VISIONAIRE™ (n = 57) or conventional instrumentation (n = 11)

Key results

Accuracy

• Mean post-TKA HKA alignment at or within 3° of neutral was achieved in 41/57 (71.9%) cases with VISIONAIRE (Figure) and 9/11 (81.8%) cases with conventional instrumentation

Conclusion

VISIONAIRE provided good implant position accuracy, comparable to conventional instrumentation.

Contribution of patient-specific cutting guides to lower limb alignment for total knee arthroplasty12

Moubarak H and Brilhault J. Orthop Traumatol Surg Res. 2014;100:S239–S242.

An evaluation of the need for blood transfusion when using patient specific instrumentation for total knee arthroplasty13

Myers K, et al. Int J Orthopedics Rehabil. 2014;2:54–60.

Figure. Mean saving in operative time and mean length of hospital stay

Figure. Post-TKA mechanical axis alignment

18.1%

71.9% of VISIONAIRE caseswithin 3° of neutral

Accuracy

Efficiency

Patient outcomes

89.6mins

116.1minsvs

MTWTFSS

WEEK 1

26.5 minssaving in

operative time

18.4% time

reduction(0.7 days; p=0.01)

VISIONAIRE

3.1mean number of days

Conventional

3.8mean number of days

≤3° >3°

page 9 of 16

Page 10: Evidence in focus...Kosse NM, 2018 Stability and alignment do not improve by using patient-specific instrumentation in total knee arthroplasty: a randomized controlled trial 8 Marimuthu

Study design• Prospective, randomised study evaluating mechanical implant alignment post-TKA• Procedures were performed by a single surgeon using VISIONAIRE (n = 15) or conventional instrumentation (n = 14)

Key results

Patient outcomes• VISIONAIRE achieved significant reductions in mean

length of hospital stay compared to conventional instrumentation (59.2 vs 66.9 hours; p = 0.43; Figure 1)

Accuracy• Mean post-TKA mechanical alignment was significantly

closer to neutral with VISIONAIRE versus conventional instrumentation (1.7 vs 2.8°, p = 0.03; Figure 2)

Efficiency• VISIONAIRE resulted in significant reductions in

mean operative time compared to conventional instrumentation (121.4 vs 128.1 minutes; p = 0.048; Figure 3)

• Mean number of instrument trays used per case was significantly reduced with VISIONAIRE compared to conventional instrumentation (4.3 vs 7.5; p < 0.0001; Figure 4)

ConclusionVISIONAIRE significantly improved mechanical alignment and operative efficiency compared to conventional instrumentation, along with significant reductions in length of hospital stay.

Study design

• Prospective evaluation of the accuracy of bone resection in TKA performed by multiple surgeons using VISIONAIRE™ (n = 41)

Key results

Efficiency

• Compared to historic data from 45 TKAs with conventional instruments

− Mean operative time was 84 minutes for VISIONAIRE and 88 minutes for conventional instrumentation (Figure)

− Mean tourniquet time was 82 minutes for VISIONAIRE and 85 minutes for conventional instrumentation (Figure)

Conclusion

VISIONAIRE demonstrated a slightly reduced mean surgical and tourniquet time compared to conventional instrumentation.

Operative efficiency and accuracy of patient-specific cutting guides in total knee replacement14 Nankivell M, et al. ANZ J Surg. 2015;85:452–455.

The value of patient-matched instrumentation in total knee arthroplasty15 Noble JW Jr, et al. J Arthroplasty. 2012;27:153–155.

Figure. Comparison of VISIONAIRE to historic conventional TKA data

VISIONAIRE Conventional

0

20

40

60

80

100

8488

82 85

Mea

n op

erat

ive

time

0

30

60

90

120

150

121.4 min 128.1 min

Mea

n nu

mbe

r of i

nstru

men

t tra

ys u

sed

per c

ase

0

1

2

3

4

5

6

7

8

4.3

7.5

Figure 3. Operative time Figure 4. Number of trays

VISIONAIRE Conventional

Efficiency

Efficiency Accuracy

Patient outcomes

5.2% reduction

42.7% reduction

Mea

n po

st-T

KA a

lignm

ent

0.0

0.5

1.0

1.5

2.0

2.5

3.0

1.7°

2.8°

Figure 2. Post-TKA alignment

p=0.03

p=0.048 p<0.0001

Mea

n le

ngth

of h

ospi

tal s

tay

0

10

20

30

40

50

60

70

80

59.2 hr 66.9 hr

Figure 1. Hospital length of stay

10.3% reduction

p=0.43

Aver

age

time

(min

)

Skin-to-skin time Tourniquet time

page 10 of 16

Page 11: Evidence in focus...Kosse NM, 2018 Stability and alignment do not improve by using patient-specific instrumentation in total knee arthroplasty: a randomized controlled trial 8 Marimuthu

Study design

• Prospective, randomised study evaluating alignment accuracy radiographically post-TKA performed by a single surgeon

• Procedures used VISIONAIRE™ (n = 30), computed tomography (CT)-based patient-specific instrumentation (PSI, n = 30) or conventional instrumentation (n = 30)

Key results

Accuracy

• Mean post-TKA mechanical limb alignment at or within 3° of the planned alignment was achieved more frequently with VISIONAIRE (93%) versus CT-based PSI (70%) or conventional instrumentation (57%) (Figure)

Conclusion

VISIONAIRE provided highly accurate mechanical alignment more frequently than both CT-based PSI and conventional instrumentation.

Small improvements in mechanical axis alignment achieved with MRI versus CT-based patient-specific instruments in TKA: a randomized clinical trial16

Pfitzner T, et al. J. Clin Orthop Relat Res. 2014;472:2913–2922.

Figure. Frequency of post-TKA coronal mechanical limb alignment ≤3° of planned

93% 70% 57%

VISIONAIRE CT-based PSI Conventional instrumentation

Study design

• Observational study evaluating HKA alignment radiographically 6 weeks post-TKA

• Procedures were performed by a single surgeon using VISIONAIRE (n = 40) or conventional instrumentation (n = 40)

Key results

Patient outcomes

• Mean Hb loss (g/dl) was 3.5 for VISIONAIRE and 4.2 for conventional TKA (Figure)

Accuracy

• Mean post-TKA HKA alignment at or within 3° of neutral was achieved in all cases

Conclusion

VISIONAIRE achieved accurate alignment, with less Hgb loss than conventional TKA.

Patient specific instrumentation versus conventional knee arthroplasty: comparative study17 Predescu V, et al. Int Orthop. 2017;41:1361–1367.

Accuracy

Accuracy

Patient outcomes

Figure. Mean Hb loss

VISIONAIRE Conventional

Mea

n H

b lo

ss (g

/dl)

0

1

2

3

4

5

4.23.5

page 11 of 16

Page 12: Evidence in focus...Kosse NM, 2018 Stability and alignment do not improve by using patient-specific instrumentation in total knee arthroplasty: a randomized controlled trial 8 Marimuthu

Study design

• Retrospective study evaluating surgical time for bilateral TKA

• Procedures were performed by a single surgeon using VISIONAIRE™ ( 15 patients) or conventional instrumentation (14 patients)

Key results

Patient outcomes

• Few complications arose, with comparable frequency between groups (Table)

Conclusion

Use of VISIONAIRE resulted in few post-TKA complications.

Reducing blood loss in bilateral total knee arthroplasty with patient-specific instrumentation18 Rathod PA, et al. Orthop Clin North Am. 2015;46:343–350.

Study design

• Prospective, randomised controlled trial evaluating HKA alignment radiographically 3 months post-TKA

• Procedures were performed by a single surgeon using VISIONAIRE (n = 51) or conventional instrumentation (n=51)

Key results

Patient outcomes• 37% (19) of patients required a blood transfusion in the VISIONAIRE group compared

to 51% (26 patients) in the conventional TKA group

Accuracy• Mean post-TKA HKA coronal alignment within 3° of the mechanical axis was

achieved in 94% of cases (48/51) using either VISIONAIRE or conventional instruments

Efficiency• Mean operative time was 11 minutes (10.6%) shorter with VISIONAIRE versus

conventional instruments (93 vs 104 minutes; Figure)

Conclusion

VISIONAIRE reduced operative time compared to conventional instrumentation, while achieving fewer blood transfusions and highly accurate limb alignment.

Comparison of customized cutting block and conventional cutting instrument in total knee arthroplasty: a randomized controlled trial19

Tammachote N, et al. J Arthroplasty. 2018;33:746–751.

Figure. Savings in operative time with VISIONAIRE, compared to conventional TKA

11 minssaving in

operative time

Efficiency Accuracy

Patient outcomes

Table. Post-TKA complications

Group Deep vein thrombosis

Pulmonary embolism

Reoperation Manipulation under anaesthesia (stiffness)

VISIONAIRE 1 0 1 (haematoma) 2

Conventional instrumentation

1 0 0 2

Patient outcomes

page 12 of 16

Page 13: Evidence in focus...Kosse NM, 2018 Stability and alignment do not improve by using patient-specific instrumentation in total knee arthroplasty: a randomized controlled trial 8 Marimuthu

Study design

• Prospective, randomised controlled trial evaluating coronal alignment radiographically post-TKA

• A single surgeon used VISIONAIRE™ (n = 47) or conventional instrumentation (n = 48)

Key results

Patient outcomes• VISIONAIRE significantly reduced mean length of hospital stay by 0.7 days

(5.0 vs 5.7 days; p = 0.005) compared to conventional instrumentation• Significantly fewer mean blood units were used (0.02 vs 0.2; p = 0.024), and

patients were less likely to require blood transfusion (1.1 vs 7.7%; p = 0.024), with VISIONAIRE compared to conventional instrumentation (Figure)

Accuracy• VISIONAIRE achieved mean post-TKA coronal alignment at or within 3° of

neutral in significantly more cases than conventional instrumentation (88.1 vs 64.1%; p = 0.011)

Efficiency• VISIONAIRE significantly reduced mean surgical time by 18 minutes (24.8%;

54.4 vs 72.4 minutes; p=0.00) compared to conventional instrumentation

Conclusion

VISIONAIRE achieved significantly more accurate coronal alignment and reduced surgical time, length of hospital stay and blood loss complications compared to conventional instrumentation.

Study design

• Prospective study evaluating radiographic alignment and functional outcomes for TKA

• Two surgeons were randomly assigned to perform procedures using VISIONAIRE (n = 31) or conventional instrumentation (n = 31)

Key results

Patient outcomes

• No significant differences in length of hospital stay or blood loss between VISIONAIRE and conventional TKA (6.68 vs 6.06 days, respectively)

• VISIONAIRE required a mean of 4 units of blood for transfusion compared to 6 units for conventional TKA (Figure)

Conclusion

VISIONAIRE may reduce the number of units of blood required for transfusion compared to conventional TKA.

Patient-specific instrumentation in total knee arthroplasty: simpler, faster and more accurate than standard instrumentation – a randomized controlled trial20

Vide J, et al. Knee Surg Sports Traumatol Arthrosc. 2017;25:2616–2621.

Functional and radiographic short-term outcome evaluation of the VISIONAIRE system, a patient-matched instrumentation system for total knee arthroplasty21

Vundelinckx BJ, et al. J Arthroplasty. 2013;28:964–970.

Figure. Mean blood units required during TKA

0.02units of blood

0.2units of blood

VISIONAIRE Conventional instrumentation

Patient outcomes

90%relative

reduction

Efficiency Accuracy

Patient outcomes

Figure. Mean blood units required during TKA

VISIONAIRE Conventional instrumentation

4units of blood

6units of blood

page 13 of 16

Page 14: Evidence in focus...Kosse NM, 2018 Stability and alignment do not improve by using patient-specific instrumentation in total knee arthroplasty: a randomized controlled trial 8 Marimuthu

Notes

page 14 of 16

Page 15: Evidence in focus...Kosse NM, 2018 Stability and alignment do not improve by using patient-specific instrumentation in total knee arthroplasty: a randomized controlled trial 8 Marimuthu

Notes

page 15 of 16

Page 16: Evidence in focus...Kosse NM, 2018 Stability and alignment do not improve by using patient-specific instrumentation in total knee arthroplasty: a randomized controlled trial 8 Marimuthu

16596 V1 0419. Published April 2019, ©2019 Smith & Nephew. Smith & Nephew, Inc, 1450 Brooks Road, Memphis, TN 38116, USA ™Trademark of Smith & Nephew. All rights reserved. All trademarks acknowledged. www.smith-nephew.com

page 16 of 16

Disclaimer Great care has been taken to maintain the accuracy of the information contained in the publication.However, neither Smith & Nephew, nor the authors can be held responsible for errors or any consequencesarising from the use of the information contained in this publication. The statements or opinions contained ineditorials and articles in this journal are solely those of the authors thereof and not of Smith & Nephew. Theproducts, procedures, and therapies described are only to be applied by certified and trained medical professionalsin environments specially designed for such procedures. No suggested test or procedure should becarried out unless, in the reader’s professional judgment, its risk is justified. Because of rapid advances in themedical sciences, we recommend that independent verification of diagnosis, drugs dosages, and operatingmethods should be made before any action is taken. Although all advertising material is expected to conform toethical (medical) standards, inclusion in this publication does not constitute a guarantee or endorsement of thequality or value of such product or of the claims made of it by its manufacturer. Some of the products, names,instruments, treatments, logos, designs, etc. referred to in this journal are also protected by patents and trademarksor by other intellectual property protection laws even though specific reference to this fact is not alwaysmade in the text. Therefore, the appearance of a name, instrument, etc. without designation as proprietary isnot to be construed as a representation by the publisher that it is in the public domain. This publication, includingall parts thereof, is legally protected by copyright. Any use, exploitation or commercialisation outside thenarrow limits of copyrights legislation, without the publisher’s consent, is illegal and liable to prosecution. Thisapplies in particular to photostat reproduction, copying, scanning or duplication of any kind, translating, preparationof microfilms and electronic data processing and storage. Institutions’ subscriptions allow to reproducetables of content or prepare lists of articles including abstracts for internal circulation within the institutionsconcerned. Permission of the publisher is required for resale or distribution outside the institutions. Permissionof the publisher is required for all other derivative works, including compilations and translations. Permissionof the publisher is required to store or use electronically any material contained in this journal, including anyarticle or part of an article. For inquiries contact the publisher at the address indicated.

References

1. Hicks C, Saunders C. VISIONAIRE: More efficient for total knee arthroplasty (TKA) than conventional techniques. 2018. Available at: http://www.smith-nephew.com/education/resources/literature/scientific-literature/2018/visionaire-more-efficient-for-total-knee-arthroplasty-tka-than-conventional-techniques/. Last accessed: 01 April 2019.

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