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Innovation in Proximal Humerus Fixation

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Andrew H. Schmidt, MDHennepin County Medical CenterUniversity of Minnesota

Disclosure InformationAndrew H. Schmidt, M.D.

Conflicts of Commitment/ EffortEditorial Board: JBJS Essential Surgical Techniques, J Knee Surgery, J Orthopaedic TraumaChief, Dept. of Orthopaedic Surgery: Hennepin County Med Ctr.

Disclosure of Financial RelationshipsRoyalties: Thieme, Inc.; Smith and Nephew.Consultant: Acumed; Conventus Orthopaedics; St. Jude Medical (spouse)Stock: Conventus Orthopaedics; Twin Star Medical; Twin Star ECS; Epien; PreferUS Healthcare, EpixResearch Support: Dept. of Defense, Univ. of Minnesota

Disclosure of Off-Label and/or investigative Uses

I will not discuss off label use and/or investigational use in my presentation.

Current PH Treatment Options

Many Options – None work in every situation

Flexible Nails Locked Rigid Nails

Locked Plates and Screws Reverse TSA Hemi

Non-Operative /Sling

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Are any of these patients back to normal?

Mean OSS in recreational athletes over 40 years old is 97.4% (58.4 out of 60)

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MCID for OSS is 6.0*

*van Kampen et al. J Orthop Surg Res 2013; 8:40

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• 92 studies, just 1 RCT• 5219 patients, but 4500 had a final follow-up,

4300 had xrays at final follow-up• 70% women• ORIF / Pinning 62 yrs, HA 70 yrs, RTSA 75 yrs

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All outcome measures favor ORIF

But….

Locking Plate Literature

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28 Articles; 2294 patients, 1147 Complications

SN ead Autho TitleFollow Up 

Time

Follo

w Up

Months # Number Rate Number Rate Number Rate Number Rate Number Rate Number Rate Number Rate Number Rate Number Rate Number Rate Number Rate

1 Geiger

Functional outcome and complications following 

PHILOS plate fixation in proximal humeral 

fractures

25.2 +/‐ 11.8 28 11 39.3% 8 28.6% 2 7.2% 6 21.4% 1 3.6% 6 21.4%

2 KilicEarly results of treatment of proximal humerus 

fractures with the PHILOS locking plate12‐19 22 4 18.2% 1 4.5% 1 4.5% 2 9.1% 1 4.5%

3 Brunner

Open reduction and internal fixation of proximal 

humerus fractures using a proximal humerus 

locked plate: A prospective multicenter analysis

3, 6 & 12 132 71 45.0% 39 24.8% 13 8.3% 4 2.6% 7 5.3% 35 22.3% 14 10.6% 2 1.5% 20 15.2% 0 0.0%

4 Sudkamp

Open reduction and internal fixation of proximal 

humeral fractures with use of the locking proximal 

humerus plate

12 155 62 40.0% 29 18.7% 6 3.9% 4 2.6% 7 4.5% 26 16.8% 15 9.7% 3 1.9% 11 7.1% 4 2.6%

5 Babst Plating in proximal humeral fractures 12.3 44 20 37.1% 6 10.9% 4 7.2% 1 1.8% 11 20.0% 1 1.8%

6 KumarOpen reduction and locking plate fixation of 

displaced proximal humerus fractures15.2 +/1 2.6 41 18 43.9% 0 0.0% 5 12.2% 4 9.8% 7 17.1% 1 2.4%

7 AgudeloAnalysis of efficacy and failure in proximal 

humerus fractures treated with locking plates4.8 153 29 19.0% 15 9.8% 7 4.6% 3 2.0% 7 4.6% 6 3.9% 7 4.6% 21 13.7% 1 0.7%

8 AksuComplications encountered in proximal humerus 

fractures treated with locking plate fixation19 103 17 16.5% 1 1.0% 5 4.9% 9 8.7% 1 1.0%

17 Konrad

Comparison of two different locking plates for 

two‐, three‐, and four‐part proximal humeral 

fractures ‐ results of an international multicenter 

12 270 119 37.4% 5 1.6% 68 21.4% 25 7.9%

18 Moonot

Early results for treatment of three‐ and four‐ part 

fractures of the proximal humerus using the 

PHILOS plate system

11 32 10 31.3% 5 15.6% 1 3.1% 3 9.4% 1 3.1% 1 3.1% 2 6.3% 2 6.3% 1 3.1%

19 KorkmazThe results of internal fixation of proximal 

humeral fractures with the PHILOS locking plate14.7 41 10 24.4% 0 0.0% 1 2.4% 0 0.0% 3 7.3% 4 9.8% 0 0.0%

20 Yang

A prospective clinical study of proximal humerus 

fractures treated with a locking proximal humerus 

plate

12 64 23 35.9% 8 12.5% 2 3.1% 2 3.1% 1 1.6% 5 7.8% 5 7.8% 3 4.7% 3 4.7%

21 SprossThe PHILOS plate for proximal humeral fractures ‐ 

Risk factors for complications at one year12 238 105 35.7% 72 24.5% 20 6.8% 10 3.4% 28 9.5% 33 11.2% 21 8.8% 17 7.1% 5 2.1%

22 KumarSurgical treatment of proximal humerus fractures 

using PHILOS plate30 49 8 16.3% 2 4.1% 0 0.0% 1 2.0% 1 2.0% 2 4.1% 4 8.2% 1 2.0% 0 0.0%

23 Erasmo

Fractures and fracture‐dislocations of the 

proximal humerus: A retrospective analysis of 82 

cases treated with the Philos locking plate

32 81 23 28.4% 12 14.8% 10 12.4% 3 3.7% 3 3.7% 3 3.7% 4 4.9% 2 2.5%

24 Jost

Locking plate fixation of fractures of the proximal 

humerus: Analysis of complications, revision 

strategies and outcome

15 121 369 305.0% 107 88.4% 82 67.8% 61 50.4% 83 68.6% 41 33.9% 16 13.2% 76 62.8% 67 55.4% 16 13.2%

25 HelwigDoes fixed‐angle plate osteosynthesis solve the 

problems of a fractured proximal humerus?12 87 53 60.9% 21 24.1% 15 17.2% 11 12.6% 12 13.8% 14 16.1%

26 Faraj

Results of 131 consecutive operated patients with 

a displaced proximal humerus fracture: an 

analysis with more than two years follow‐up

28.8 92 36 39.1% 27 29.3% 0 0.0% 11 11.9% 6 6.5% 6 6.5% 2 2.2%

27 BroderManagement of proximal humerus fractures with 

the Equinoxe Locking plate system16.8 49 5 10.2% 4 8.2% 3 6.1% 0 0.0% 1 2.0% 3 6.1%

28 Rodia

Fixation of complex proximal humeral fractures in 

elderly patients with a locking plate: A 

retrospective analysis of radiographic and clinical 

outcome and complications

12 51 5 9.8% 0 0.0% 0 0.0% 4 7.8% 0 0.0% 0 0.0% 0 0.0% 0 0.0% 0 0.0%

Totals 424.5 2294 1147 41.8% 431 20.0% 193 7.5% 69 5.3% 139 7.2% 343 13.3% 159 8.8% 60 6.1% 143 11.0% 178 11.7% 34 3.7%

Plate 

ImpingementRevision

Loss of 

Fixation/Reduct

ion

Non‐Unions Overall 

ComplicationsRe‐Operation AVN

Screw 

PerforationMalunion

Removal 

(Plates)

Removal 

(Screws)

4 18.2

15 9.8% 7 4.6%

8 12.5%

41.8%

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Current Surgical Options Have High Complications

Technology Pros ConsComplication

Rate

Closed Reduction and Percutaneous Pinning (CRPP)

• Minimize soft tissue trauma• Reduce risk of AVN• Less dissection / less

disruption of vascular supply• Less scarring / easier rehab

• Poor stability, particularly in comminuted fractures and osteoporotic bone

• Risk of injury to neurovascular structures• Loss of reduction • Pin site pain and/or infection

~ 25%

Plates • Can be used to aid in reduction• Familiar technique• Early ROM

• Extensive dissection / risk of AVN• Screw loosening / cut-out• Collapse / loss of reduction• Screw perforation of articular surface• Varus malalignment• Impingement of plate on acromion• Greater potential for adhesions and scarring

~ 40%

Intramedullary Rods • Less Invasive than plates• Limited tissue trauma• High primary stability

• Violates rotator cuff / source of pain & dysfunction• Rod migration• Screw perforation• Secondary loss of reduction• Limited fracture patterns

~ 20-30%

Hemiarthroplasty • Manages pain / AVN• Stability in complex fx /

osteoporotic bone

• Anatomical restoration difficult• Reduced ROM• Malunion / nonunion of tuberosities

~ 35%

Total Shoulder Arthroplasty - Reverse or Conventional

• Satisfactory mobility• Predictable

• ROM limitations• Scapular notching• Limited longevity of implant / options post-implant

~ 35%

Sources: Fakler – Orthopaedics 2008; Brunner – JOrthopTrauma 2009; Ebraheim – ActaOrthopBelg 2007; Fogerty -JOrtho 2009; Nho – JBJS 2007; Mauro – CurrRevMusculoskeletMed 2011

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Outcomes remain substandard with both operative and nonoperative management of proximal humeral fractures

Surgical methods all have high complications

There is still room for improvement !

Results: The following parameters were found to have a significant influence on the failure rate: Age, local BMD, anatomic reduction, and restoration of the medial cortical support.

The failure rate significantly increased with the number of risk factors.

Predictors of PH Repair Failure

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Predicting failure after surgical fixation of proximal humerus fractures Dietmar Krappinger, Nicola Bizzotto, Stephan Riedmann, Christian Kammerlander, Clemens Hengg *, Franz Sebastian KralingerDepartment of Trauma Surgery and Sports Medicine, Innsbruck Medical University, Anichstraße 35, A-6020 Innsbruck, Austria

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* Slide courtesy of James Green, Synthes USA

41 yrs 52 yrs 60 yrs

* Slide courtesy of James Green, Synthes USA

56 yrs 61 yrs 61 yrs

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Unmet Clinical Need

1. Compensating for poor bone mineral

density and bone loss

2. Achieving and maintaining anatomical

reduction of the head and the

tuberosities

3. Restoration of medial column support

4. Managing rotator cuff forces

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Peer reviewed literature suggests that factors of critical importance in successful ORIF are:

Bone Density Augmentation Strategy

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Genesis of a New Approach

• Local group of business people/ engineers with significant experience designing expandable nitinolmedical devices

• Wondered about orthopedic applications… especially for metaphyseal fracture patterns

Pla

tes

& S

crew

s

•Invasive

•Hardware Complications

•Dictates Reduction

•Asymmetrical Construct

•Stress Risers

•Strong

•Early Motion

•Easier Patient Management

•Easy Technique

•Minimally Invasive

•No Long-term Hardware

•Fragment Specific

•Freedom to Restore

Anatomy•Minimally Invasive•No Long-term

Hardware Issues•Freedom to

Restore Anatomy

•Limited Long-term hardware Issues

•Centralized Strength•Minimally Invasive

Intramedullary Nails/Rods

Per

cuta

neou

s P

inni

ng

External Fixation

•Weak Construct

•No Early Motion

•Patient Management

•Pin Tract

•Fragment Stability

•No Early Motion•Patient Management•Pin Tract•Fragment Stability

•No Early Motion•Patient Management•Pin Tract•Fragment StabilityIdeal Technology

Intersection

Intramedullary Design

Minimally Invasive Intramedullary Scaffold

1. Fragment specific reduction

2. Interfragmentarycompression

3. Subchondral support

Expandable NitinolScaffold

Fragment Screw

Proximal Screws and Proximal Plate

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Distal radius fractures— A solved problem, or can we do better?

2006

2007 2006

2008

2011

2010

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Return to Normal Daily Activities

0

5

10

15

20

25

30

35

12 weeks 26 weeks 52 weeks

DA

SH

Sco

re (

0-10

0)H

igh

Sco

re =

Mor

e S

ymp

tom

s

Follow-up Timepoint

External Fixation

Volar Plate

Conventus

DRS clinical results vs. Egol et al., JBJS[Br] 2008

DASH Comparison

Fewer ComplicationsSystematic Review of 56 Published Studies (2004-2012), Majority < 100 pts

Complications include: Loosening/Failure, Loss of Reduction, Irritation/Discomfort, Infection, Tendon Rupture, Tenosynovitis/ Tendonitis, Median Nerve Injury, Radial Nerve Injury, Compartment Syndrome, Carpal Tunnel, Wound Infection, Skin/Wound Healing, Malunion/Delayed Union, Nonunion, Stiffness, CRPS, RSD, Sudek's, Joint Instability/Impingement

Sources available upon request

0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0%

35.0%

40.0%Complication Rate Average

External Percutaneous Volar ConventusFixation Pinning Plating DRS

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Bone Density Augmentation Strategy

Engineered Augmentation with Multiple Fixation Opportunities

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Medial Support

Zhang W, Zeng L, Liu Y, Pan Y, Zhang W, et al. (2014) The Mechanical Benefit of Medial Support Screws in Locking Plating of Proximal Humerus Fractures. PLoS ONE 9(8): e103297. doi:10.1371/journal.pone.0103297http://journals.plos.org/plosone/article?id=info:doi/10.1371/journal.pone.0103297

Engineered Support with Multiple Fixation Opportunities

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The PH CAGE Solution

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Bone Density Augmentation• Distributes load over large surface area• Provides subchondral buttress to

support articular surfaceManage Tuberosity & Cuff Forces• Tuberosity specific re-approximation• Optional suture washers for soft tissue

management

Shown with Optional Plate

Medial Column Support • Sub-Chondral buttress limits head

collapse and thus limits collapsing forces across calcar and medial cortical area

• Torsional stability and medial support provided by construct

Polyaxial Screw Placement & Locking Capabilities• Screw cage interface provides

locking capabilities• Place screws in any orientation

necessary

Maintain Reduction• 3-Dimensional support

prevents collapse and loss of reduction during the healing phase

• Cage helps maintain reduction during the surgical procedure

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Axial Stiffness of Constructs

Sample size for axial loading:

o PH Cage, PH Cage w/Plate N = 5

o PHILOS N = 3

Axial stiffness, PHILOS < PH Cage* < PH Cage w/Plate* (* statistically significant)

No deviations from test protocol & setup

Schmidt A et al., “Biomechanical performance of a proximal humeral Cage (PH Cage) in comparison to a locking plate technology”

PH Cage w/PlatePH Cage PHILOS

0

300

600

900

1200

1500

1800

0 1 2 3 4

Axial Load

 (N)

Displacement (mm)

PH Cage PH Cage w/Plate PHILOS

Units (N/mm)

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Axial Failure Loads

PH Cage w/Plate

o Only 1/5 failed. The remaining 4/5 reached a maximum load of 1900N without failure.

Failure load, PHILOS < PH Cage < PH Cage w/Plate* (* statistically significant)

No deviations from test protocol & setup

Schmidt A et al., “Biomechanical performance of a proximal humeral Cage (PH Cage) in comparison to a locking plate technology”

PH Cage PH Cage w/Plate PHILOS

Units (N)

SetupNo. of TestSamples

No. of Failures

PHILOS 3 3

PH Cage 5 5

PH Cage w/Plate 5 1

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Plate Retrograde Technique

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PH Cage - Patient DemographicsAge Distribution

Gender

78.4%

21.6%

Female

Male

Fracture Type

30.3%

44.0%

20.6%

5.0%

2- Part

3- Part

4- Part

Other

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PH Cage – Surgical Technique

Deltopectoral

Deltoid Split

Minimally Invasive

72.6%

7.4%

20.0%

Deltopectoral Deltoid Split Minimally Invasive

PH Cage – Procedural DataRetrograde Antegrade (Drop In)

PH Cage implantation with & without a plate can be completed using both procedures

o PH Cage Only = 31% of procedures

o PH Cage + Plate = 69% of procedures

88.8%

11.2%

Retrograde Antegrade (Drop In)

35.8%

19.3%

5.8%

4.1%

5.4%

13.3%

7.5%

4.2%

4.6%

1.4%

8.2%

6.2%

5.9%

0.0%

1.0%

3.6%

1.0%

4.9%

1.3%

0.7%

1.3%

1.6%

0.0% 5.0% 10.0% 15.0% 20.0% 25.0% 30.0% 35.0% 40.0%

COMPLICATIONS

RE-OPERATIONS

AVN

PLATE IMPINGEMENT

REVISION

SCREW PERFORATION

TOTAL HARDWARE REMOVAL

PARTIAL HARDWARE REMOVAL

MALUNION

NONUNION

LOSS OF FIXATION/REDUCTION

PH Cage Locking Plates

PH Cage vs. Locking PlatesLocking plate complications is obtained from literature review meta-analysis (~2300 Pts)

22.1%19.9%

31.6%

26.4%

0.0%

10.0%

20.0%

30.0%

40.0%

0 - 3 3 - 6 6 - 12 >12

Post Op Time (Months)

PH Cage complication rate is approximately 1/5th as compared to locking plates

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Surgical Technique

• Similar to current plating procedures

• Angled bushing for consistent access

• Poly-axial screw placement

• Screws lock into Cage

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CASE EXAMPLES

56 year old male in MVA

Case Example

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Case Example

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Case Example

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Is this the answer?

Clinical studies are the next step…