Precision of the Precice Internal Lengthening Nailllrs.org/PDFs/Annual Meeting Presentations/Friday...
Transcript of Precision of the Precice Internal Lengthening Nailllrs.org/PDFs/Annual Meeting Presentations/Friday...
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Precision of the Precice® Internal Lengthening Nails
Yatin Kirane, MBBS, D.Ortho, MS, PhD Austin T. Fragomen, MD S. Robert Rozbruch, MD
Limb Lengthening and Complex Reconstruction Service Hospital for Special Surgery, New York, NY
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Disclaimer
I have nothing else to disclose
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Introduction:
External Fixators – Paley et al., JBJS 1997; Herzenberg et al., JBJS 1997
Hybrid Techniques
◦ LON (lengthening over nail) – Paley et al. JBJS 1997; Mahboubian et al., CORR 2012
◦ LATN (lengthening and then nailing) – Rozbruch et al., CORR 1997
Internal lengthening Devices (ILD)
◦ Albizzia/ Guichet nail – Guichet et al., JBJS, 2003; Mazeau PJ Pediatr Orthop B. 2012
◦ Fitbone – Dinçyürek et al. Acta Orthop Traumatol Turc. 2012;, Krieg AH, Acta Orthop 2011
◦ ISKD (Orthofix) – Cole et al., Injury 2001; Mahboubian et al., CORR 2012; Kenawey et al., CORR 2011;
Bone Lengthening Techniques
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Clinical Outcomes of ILD
Successful (good to excellent) outcomes – Cole et al., Injury 2001; Guichet et al., JBJS, 2003; Hankemeier et al., Arch Orthop Trauma Surg. 2004
Complications - Papanna et al., Acta Orthop Belg 2011; Mazeau PJ Pediatr Orthop B. 2012; Kenawey et al., CORR 2011;
Mahboubian et al., CORR 2012
◦ “run away nails” ◦ Inaccurate and unreliable distraction ◦ Premature consolidation ◦ Nonunions ◦ Nerve injuries ◦ Joint contractures
Need for more accurate ILD
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Telescopic, magnet-operated device
Recent FDA approval
Clinical efficacy not established
External remote control magnet in
operation
Precice® Nail Ellipse Technologies Inc., Irvine, CA
Precice® Nail
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Surgical Technique Rotation marker pins
Vent hole & multiple drill hole osteotomy
Osteotomy completion before advancing the nail
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Localization of the internal magnet
Intraop Magnet Localization & Distraction
Intraop distraction
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17 femur and 8 tibia lengthening cases
Medical records were reviewed for: ◦ Patient characteristics
◦ Etiology
◦ Surgery details
◦ Distraction process
◦ Bone alignment
◦ Adjacent joint range of motion (ROM)
◦ Any complications
Methods
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Demographics
Etiology # of Cases
Congenital/ Developmental 10
Post-traumatic growth arrest 5
Fracture malunion 4
Short stature 4
Post-arthodesis 1
Tumor resection 1
Male Female
18 5
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I. Accuracy of Lengthening ◦ Distraction distance & accuracy measured using a
calibrated digital radiology system (PACS, OnePacs LLC, New York, NY)
II. Change in bone alignment
III. Effect on adjacent joint ROM
Primary Outcome Variables
A) % Error = Distraction prescribed
X 100 Distraction prescribed – Lengthening measured
B) Accuracy of distraction = 100 - % Error
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I. Accuracy of Lengthening At 19 weeks follow-up (range, 1-42 weeks):
Average lengthening was 33.65 mm (range, 14mm-61mm)
Accuracy was 99.3% ± 0.23%
34.47 33.65
-5.00
5.00
15.00
25.00
35.00
45.00
55.00
Distraction Done Distraction Measured
Dis
trac
tio
n (
mm
)
Distraction Prescribed Lengthening Measured
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II. Absolute Change in Bone Alignment
BONE ANGLE ABSOLUTE CHANGE
(degrees)
Mean Range
Femur Lateral distal femoral angle (LDFA) 2 0-4
Procurvatum/Recurvatum 6 0-12
Tibia Medial proximal tibial angle (MPTA) 3 0-6
Procurvatum/Recurvatum 3 1-5
Intentional reduction of femur bow (5/17)
Blocking screws (4/17 femur & 6/8 tibia)
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III. Joint ROM
MOTION ABSOLUTE LOSS (degrees)
Mean Range
Knee Flexion 13 0-30
Knee Extension 0 0-2
Ankle Dorsiflexion 3 0-15
Ankle Plantarflexion 6 0-20
ITB release (10/17 femur)
Gastrocnemius recession (5/8 tibia)
Hip, knee and ankle ROM well maintained
Temporary loss of motion in early postop period
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Overall Clinical Outcomes
All femur cases had excellent bone healing
In 2 tibia cases, BMAC was injected for delayed bone healing
There was 1 case of failure of the magnet mechanism requiring nail exchange
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Example 1: Anterograde Femur
14M
3.8 cm LLD
20° ER deformity
Progressive LLD since birth
Back and hip pain
Difficulty playing sports
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Example 1: Anterograde Femur 24 weeks
after surgery
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Example 2: Retrograde Femur 30M
3.6 cm LLD
7° genu valgum (MAD 14 mm lateral)
10° ER deformity
Post-traumatic growth arrest after R femur Fx
Lower back and R LL pain
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Example 2: Retrograde Femur
24 weeks after surgery
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Example 3: Tibia 37F
7 cm LLD
Pain in the left leg
h/o multiple hip surgeries including THR
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Example 3: Tibia
12 weeks after
surgery
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Conclusion & Summary The new Precice® nails have excellent clinical efficacy
with ~ 100% accuracy
Implant failure: 4% (1/25)
No other major complications
Use of remote control was straightforward
Acute rotational and angular correction was possible
Malalignment was prevented by using correct nail size, osteotomy level and blocking screws
Length of the thicker nail segment beyond the osteotomy is critical to ensure stability and prevent iatrogenic deformities
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