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VISIONAIRE Clinical Selection

Table of contents

VISIONAIRE™ Clinical Study Collection

Page Author Title Accuracy Efficiency

2 Pfitzner et. al. Small Improvements in Mechanical Axis Alignment CORR, 2014 x x

3 Vide J et. al.Patient-specific instrumentation in total knee arthroplasty: simpler, faster and more accurate than standard instrumentation – a randomized controlled trial, 2015

x x

4 DeHaan et. al. Patient-Specific Versus Conventional Instrumentation for Total Knee Arthroplasty: Perio-perative & Cost Differences; J Arthroplasty, 2014 x

4 Daniilidis et. al. A comparison of conventional and patient-specific instruments in total knee arthroplasty; Int Orth, 2013 x

5 Heyse et. al. Improved femoral component rotation in TKA using patient specific instrumentation; The Knee, 2012 x

5 Drnek et. al.Patient-specific instruments as a standard procedure in total knee arthroplasty: Logistics and postoperative radiological results in 70 patients; Case Reports in Clinical Medicine, 2014

x x

6 Daniildis et. al. Frontal plane alignment after total knee arthroplasty using patient-specific instruments; Int Orth, 2012 x

7 Bali et. al. Custom Fit Total Arthroplasty: Our Initial Experience in 32 Knees; J Arthroplasty, 2012 x x

8 Noble The Value of Patient-Matched Instrumentation in Total Knee Arthroplasty; J Arthroplasty, 2012 x x

9 Myers et. al. An Evaluation of the Need for Blood Transfusion When usingPatient Specific Instrumentation x

10 Heyse, T. and Tibesku, C.

Improved tibial component rotation in TKA usingpatient-specific instrumentation x

Study summary: • Randomized Controlled Study (Level 1 Evidence)• 90 TKA’s: 30 VISIONAIRE™ (MRI) CG (MRI),

30 TruMatchTM (CT) CG, 30 STD Instrument

Results:• 93% (28/30) Coronal Mechanical Axis Accuracy

(±3™) vs 57% STD and 70% TruMatch• 24% Less Surgery Time vs STD

(Avg. 58 min v. 76 min)• 87% (26/30) Femoral Rotation Accuracy vs

50% STD• 90% (27/30) Tibial Slope Accuracy vs 63% STD• 83% Femoral/Tibial Sizing Accuracy

(no adjustments)• KSS and WOMAC scores were similar

between PSI and STD

Note: Authors conclusion is that “Although this study supports that patient specific instrumentation increased accuracy compared with conventional instrumentation… differences are only subtle and of questionable clinical relevance.”

Clinical Orthopaedics and Related ResearchSmall Improvements in Mechanical Axis Alignment Achieved With MRI versus CT-based Patient-specific Instruments in TKAA Randomized Clinical TrialPfitzner T, Abdel MP, et. al; 2014

Coronal Alignment Inliers (<3°) from Mechanical Neutral

0%

20%

40%

60%

80%

100%93%

57%

p<.002

70%

Avg. Surgery Time (min)

0

10

20

30

40

80

58

76

6350

60

70

Posterior Tibial Slope Inliers (+-3°)

0%

20%

40%

60%

80%90%

63%

p=.05100%

Median Deviation from Plan

1

2

3

4

0

5

Femoral Rotational Inliers (±3°)

Sizing Accuracy*

0%

10%

20%

30%

40%

80%

50%

60%

70%

87%

0%

20%

40%

60%

80%87%

50%

p=.01100%

87%

4.5

1 1 1

2.7 3

1

4

1

3.5

Long-leg mechanical axis

Mechanical axis of femur

Mechanical axis of tibia

Rotation alighnment of femur

Posterior tibial slope (from 3º)

90%

80%

53%

83%

FEM FEM

60%

TIB FEM

83%

TIB

70%

TIB

VISIONAIRE Technology STD TruMatch

n = 30

p<.002

n = 30 n = 30

n = 30 n = 30 n = 30

n = 30 n = 30 n = 30n = 30n = 30 n = 30

24% shorter

2

*Accuracy of planned vs actual size used in surgery

3

Knee Surg Sports Traumatol ArthroscPatient-specific instrumentation in total knee arthroplasty: simpler, faster and more accurate than standard instrumentation – a randomized controlled trial

Vide J, Freitas TP, Ramos A, Cruz H, Sousa JP; 2015

Coronal Alignment Outliers

VISIONAIRE Technology

STD

0%

10%

20%

30%

40%

36%

12%

Study summary: • Randomized Controlled Study (Level 1 evidence)• 95 TKA’s: 47 VISIONAIRE™, 48 STD Instruments

Results:• 24% fewer coronal alignment outliers (>3°)

with PSI over STD (11.9% vs 35.9%)• 24.8% less surgery time vs STD (Average 54.4min

vs 72.4 min)• 12% Reduction in length of stay (Average 5.0 days

vs 5.7 days)• Fewer blood units administered when PSI was

used (Average 0.02 BUs vs 0.2 BUs)• Higher number of patients with transfusions when

STD was used (7.7% vs 1.1%)• No PSI Procedures had to be Converted to STD• No changes occurred in the tibial or femoral sizes.• 2 PSI cases had to be recut due to existing flexion

contracture and insufficient extension gap.• 2 patients, 4.3%, required soft tissue balancing. • Insert exchange occurred in 5 patients, 10.6 %,

all from a 9 to an 11mm, due to removal of significant osteophytes.

Study Conclusions: The most relevant finding of the present study is a reduction of outliers from the intended coronal TFA window with PSI. This is achieved with additional advantages: reduction in surgical time, LOS and transfusion rates.

This technology promises simpler and faster procedures with better accuracy, which hopefully will lead to greater patient satisfaction and higher implants survival rates.

Study limitations: Limitations of the study were the lack of blinding, no power analysis or sample size calculation were performed and lack of evaluation of clinical function, satisfaction, sagittal and rotational alignment.

Average Surgery Time (min)

VISIONAIRE Technology

STD

0

10

20

30

40

50

60

p=.000

54

70

80

72 24.8% shorter

24% fewer

International Orthopaedics Publication A comparison of conventional and patient-specific instruments in total knee arthroplasty

Daniilidis, Tibesku (Germany); Jul 2013

Coronal Plane Alignment Accuracy (+-3˚)

VISIONAIRE Technology

STD

0%

20%

40%

60%

80%79%

100%

120%

n = 150

p<.05

91%

n = 156

Study summary: • Retrospective, case comparative study• 306 total knee arthroplasty - 150 patients with STD instruments - 156 patients with VISIONAIRE• No intra-operative complications with VISIONAIRE

Results:• 91% of VISIONAIRE cases within +/-3º in the

frontal plane• 79% of STD cases within +/-3º in the frontal plane

Study limitations: The notable demographics differences between study groups, lack of clinical and functional outcome data, absence of a power-analysis calculation, and high level of surgeon experience may limit the reliability of the results. The long-term impact of PSI on clinical outcome and survivorship should be considered in future studies.

4

120

Study summary: • Retrospective review (Level III Evidence)• Performed at a single center (OHSU) by a single

fellowship trained surgeon in Portland, OR• 356 TKA’s: 306 VISIONAIRE™ CG, 50 STD Instruments

Results:• 31% Less Tourniquet Time w/VISIONAIRE

(~20 min less)• 24% Less OR Time with VISIONAIRE (~21 min less)• 30% Less Room Turnover Time with VISIONAIRE

(6 min less)*

Study limitations: clinical outcome was not measured, the sample size was small, participants were not prospectively randomized, and bias may exist due to surgeon basing intraoperative judgment of correct rotational positioning on the epicondylar axis. Future well-designed randomized controlled trials are needed to add to the body of literature surrounding patient specific instrumentation.

* value revised from 42% to 30% due to a calculation error in the paper.

The Journal of Arthroplasty PublicationPatient-Specific Versus Conventional Instrumentation for Total KneeArthroplasty: Peri-Operative and Cost DifferencesDeHaan AM, Huff, TW, et al; 2014

Avg. Tourniquet Time (min)

0

20

40

60

80

63.383.2

100p=.024

OR Time (min)

0

20

40

60

8086.8107.2 100

p=.022

n = 50 n = 306

n = 50 n = 306

VISIONAIRE Technology

STD

31%shorter

24% shorter

Study summary: • Prospective Observational Study• Multiple surgeons at Teaching Institution in Austria• 73 TKA’s (3 bailouts to conventional instruments)

Results:• 92.9% (65/70) Neutral Coronal Mech. Axis Inliers (±3°) • 77.6 min average OR time• 94.3% femoral sizing accuracy (no adjustments)• 74.3% tibial sizing accuracy (no adjustments)• 85.7% had zero soft tissue releases

Study limitations: This case series did not compare VISIONAIRE to procedures completed with conventional instrumentation at the same institution, and only evaluated PSI from one manufacturer, limiting the results of this study. The authors recommend future comparative studies investigate the effect of different image modalities and block designs on radiological outcomes.

Case Reports in Clinical Medicine Publication Patient-specific instruments as a standard procedure in total knee arthroplasty: Logistics and postoperative radiological results in 70 patientsDominik Drnek, Nicolas Haffner, Armin Sadjed, Peter Ritschl; 2014

% Inliers for Coronal Alignment (±3º)

VISIONAIRE Technology

0%

10%

20%

30%

40%

80%93%

50%

60%

70%

90%

5

Study summary: • Retrospective study composed of 94 TKA

comparing femoral rotation in VISIONAIRE™ (46TKA) vs STD instruments (48TKA)

• Postoperative MRI used to measure implant positioning

• Deviations >3° were considered outliers• All VISIONAIRE cutting guides had excellent fit

with no abandonments

Results: Rotational Inliers (±3° from Trans-Epicondylar

Axis (TEA)• 77.1% STD (11/48)• 97.8% VISIONAIRE (1/46)

Study limitations: Clinical outcome was not measured, the sample size was small, participants were not prospectively randomized, and bias may exist due to surgeon basing intraoperative judgment of correct rotational positioning on the epicondylar axis. Future well-designed randomized controlled trials are needed to add to the body of literature surrounding patient specific instrumentation.

The Knee Publication Improved femoral component rotation in TKA using patient-specific instrumentation

Thomas J. Heyse (Germany), Carsten O. Tibesku (Germany); November 2012

Femoral Rotation Accuracy

VISIONAIRE Technology

STD

50%

55%

60%

65%

70%

90%

98%

77% 75%

80%

85%

n = 48 n = 46

95%

100%p<.05

Study summary: • Retrospective study• 100 VISIONAIRE™ TKA’s (96 patients)• No intraoperative complications and optimal

block fit in all instances

Results:• 89% of cases +/-3° in the frontal plane

(11% outliers)• This study compares these results to published

results with computer-assisted navigation and conventional instrumentation1

– 89.8% of navigation cases reported within +/-3º in the frontal plane (10.2% outliers)

– 71.8% of conventional cases reported with +/-3º in the frontal plane (28.2 outliers)

Study limitations: STD and NAV results taken from a previous study. Results were not compared to a cohort of patients who underwent TKA, either with conventional instruments or computer navigation, within the same time frame at the center, making comments on efficacy compared to these techniques would be unreasonable.

1. Ng VY, DeClaire JH, Berend KR, Gulick BC, Lombardi AV Jr (2012) Improved accuracy of alignment with patient-specific positioning guides compared with manual instrumentation in TKA.Clin Orthop Relat Res 470:99–107

International Orthopaedics Publication Frontal plane alignment after total knee arthroplasty using patient-specific instrumentsKiriakos Daniilidis (Germany) and Carsten O. Tibesku (Germany)

Coronal Plane Alignment

0%

10%

20%

30%

40%

50%

89%

60%

70%

80%

90%

100%

VISIONAIRE Technology

6

90%

72%

STD

CAS

Study summary: • Prospective cohort study with

retrospective analysis• 32 TKA’s; 10 Contralateral

(4 VISIONAIRE™ vs CAS, 6 VISIONAIRE vs STD)

• 97% sizing accuracy for all components.

• Coronal alignment restored within ±3˚ = 90% of 29 of 32

Results (10 contralateral patients): VISIONAIRE vs STD – Six patients• Overall skin to skin time reduced by

average of 11min (14%) in VISIONAIRE• Overall blood loss was

reduced by average of 117ml (64%) in VISIONAIRE

• Average mechanical axis for VISIONAIRE was -1.16° vs -1.33° for STD

VISIONAIRE vs CAS – Four patients• Overall skin to skin time reduced

by avg of 41.5 minutes (40%) in VISIONAIRE

• Overall blood loss reduced by average of 45ml (36%) in VISIONAIRE

• Average mechanical axis for VISIONAIRE was -0.25° vs -0.50° for CAS

Study limitations: The comparison to previous contralateral TKA in 10 patients was conducted retrospectively. It is not known if prospective and retrospective measurement techniques employed similar methodology in these bilateral cases. Limitations in the methods employed in these comparisons do not allow readers to draw conclusions on comparative efficacy between custom instrumentation, conventional instrumentation, and computer navigation. It is unclear whether measurement of blood loss, skin to skin time and mean mechanical axis were measured similarly in non-PSI procedures. Evidence from randomized controlled trials is required before comparative conclusions can be drawn.

The Journal of Arthroplasty PublicationCustom Fit Total Arthroplasty: Our Initial Experience in 32 Knees

Kamali Bali, MBBS, MS, DNB, Peter Walker, FRACS, and Warwick Bruce, FRACSJ Arthroplasty. 2012 Jun;27(6):1149-54. Epub 2012 Jan 27.

7

Mean Skin-to-Skin Minutes

65

70

75

80

85

80.6

90

95

100

105

110

69.6

VISIONAIRE Technology

STD

14% reduction

CAS

115

111.1

Study summary: • Randomized controlled study n=29 (15

VISIONAIRE™, 14 STD)• Postoperative MRI used to measure implant

positioning• Deviations >±3º were considered outliers• All VISIONAIRE cutting blocks had excellent fit

with no abandonments• No instrument related adverse events or

complications reported

Results:• Average mechanical alignment: 1.7

VISIONAIRE, 2.8 STD (39% better), p=.03• OR time (min) 121 VISIONAIRE, 128 STD

(5% less), p<.05• LOS (hrs) 59.2 VISIONAIRE, 66.9 STD

(12% less), p<.05• Instrument trays (#) 4.3 VISIONAIRE, 7.5 STD

(43% less), p<.05• Incision length 136mm VISIONAIRE, 151 STD

(10% shorter), p<.05

Study limitations: Small sample size, results need to be repeated in a larger randomized trial before patient matched instrumentation is adopted as a superior treatment.

The Journal of Arthroplasty Publication The Value of Patient-Matched Instrumentation in Total Knee Arthroplasty

Noble, J, et. al; Jan 2012

Length of Hospital Stay (hours)

VISIONAIRE Technology

STD

0

10

20

30

40

80

66.959.2 50

60

70

n = 15 n = 14

Avg Mechanical Alignment (deg)

0

0.5

1

1.5

2

2.8

1.7

2.5

3

n = 15 n = 14

p<.05

p=.05

12% reduction

39% reduction

8

Study summary: • Retrospective Study• 45 patients - 21 VISIONAIRE™ (12 unilateral; 9 bilateral) - 24 STD (19 unilateral; 5 bilateral)

Results:• Significantly less need for blood transfusion with

VISIONAIRE Bilateral Cases - 0.0% (0/9) VISIONAIRE Bilateral and 60.0%

(3/5) STD Bilateral• Operative time and tourniquet time for

VISIONAIRE unilateral and bilateral were both significantly less than conventional (p<0.01)

- (99.7±18.0min min) VISIONAIRE vs (126.4±27.7 min) STD

• Both VISIONAIRE unilateral and bilateral patients had significantly shorter length of stay (p<0.01)

- (3.1±0.3 days) VIS vs (3.8±0.4 days) STD

International Journal of Orthopedics and RehabilitationAn Evaluation of the Need for Blood Transfusion When using Patient Specific InstrumentationMyers, et. al; 2014

Number of patients transfused

0%

20%

30%

40%

50%

60%

70%

0% 11%

VISIONAIRE Technology

STD

0%

60%

Unilateral TKA Bilateral TKA

Study limitations: This study was a retrospective study with low numbers of patients and included post-hoc subgroup analysis. Additionally, patients self-selected whether they would have PSI or traditional instrumentation, which may introduce a level of bias.

9

1

2

3

4

5

6

7

8

Study summary: • Retrospective study• 58 patients (30 VISIONAIRE/28 STD)• Three tibial measurement methods compared

using a tangent to the tibial keel as a reference• Inter- and intra- observation

Results:• Excellent inter- and intra-observer reliability

with low standard deviation• Dorsal tangent reference (p<0.01) - Excessive external rotation: (28.6%)

8 STD vs (6.7%) 2 VISIONAIRE - Relative internal rotation: (5.4°)

1 STD vs 0 VISIONAIRE• Tibial epicondyles reference (p<0.05) - Excessive external rotation: (21.4%)

7 STD vs (6.7%) 2 VISIONAIRE - Relative internal rotation: (4.4°)

1 STD vs 0 VISIONAIRE• Tibial tubercle showed poor reproducibility and

considered of little use

p value represents relative internal rotation

Archives of Orthopaedic and Trauma SurgeryImproved tibial component rotation in TKA using patient-specific instrumentation

Heyse, T. and Tibesku, C. 2015

Rotational Axis comparison

0External Internal External Internal

VISIONAIRE Technology STD

Dorsal Epicondyles

Study limitation: The dorsal tangent to the tibial epicondyles and the tibial epicondylar line has never been used to correlate clinical symptoms with rotational component alignment.

Future studies will be needed to show if reducing outliers from optimal rotational tibial component alignment during TKA is of clinical relevance.

10

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