New Implantable Lengthening Nail: Preliminary Results. Matthew Harris MD, MBA Dror Paley MD, FRCS(C) Daniel Prince MD, MPH
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1 New Implantable Lengthening Nail: Preliminary Results Matthew Harris MD, MBA Dror Paley MD, FRCS(C) Daniel Prince MD, MPH LLRS New York, NY July 19, 2013
2 Disclosures Dror Paley MD, FRCS(C) Paid Consultant Ellipse Technologies Matthew Harris MD, MBA None Daniel Prince MD, MPH None
3 Pre-operative Diagnosis Diagnosis Patients Females Males Stature Lengthening Congenital LLD Post-traumatic LLD Developmental LLD Totals
4 Surgical Technique Implant Location # of Pts # nails Femoral Piriformis Trochanteric Retrograde 6 7 Tibial 12* 15* Fibular 1 2 Humeral 1 1 Totals * 3 nails retrograde (3 patients)
5 Post-Traum. & Develop. LLD Results N = 19 * Range Mean LLD (cm) Actual Gained (cm) Distraction Rate (mm/day) Time until Healed (days) One complication in this group deep infection * Total = 13 males, 6 females
6 Congenital LLD Results N = 26 * Range Mean Pre-op Goal (cm) Actual Gained (cm) Distraction Rate (mm/day) Time until Healed (days) * Total = 9 males, 15 females
7 Congenital LLD Complications N = 26 # events # of Pts Fixation Cutout 1 1 Symptomatic Hardware 2 2 Peri-implant Fracture 1* 1 Deep Infection 2* 2 Deficient Regenerate/Grafting 3* 3 Soft Tissue Contracture Release 2 1 Hematoma Evacuation 1* 1 * One patient had four complications
8 Congenital LLD Complications (Cont.) N = 26 # events # of Pts Superficial Skin Infection 1 1 Dense Regenerate / Resistance 1 1 Pt. Request to Stop Lengthening 2 2 Joint Subluxation 2* 1* Unplanned Surgical Procedures 12** 8** * Patient was undergoing ipsilateral Femur and Tibia lengthening ** Patient RK had four complications
9 Stature Patient Demographics N = 17* Range Mean Age (yrs) Follow-up (mos) Pre-op Height (cm) Pre-op Goal (cm) * Total = 13 males, 4 females
10 Stature Patient Results N = 17* (36 nails**) Range Mean Pre-op Goal (cm) Actual Gained (cm) Distraction Rate (mm/day) Time until Healed (days) * Total = 13 males, 4 females ** One pt. with femurs and tibias
11 Stature Complications N = 17 (36 nails) # nails # Pts Implant Breakage Nail Broke/Fatigue Failure 3 2 Lengthening Mechanism Failed 6* 4* Compartment Syndrome 1 1 Soft Tissue Contracture Release 4 2 Unplanned Surgical Procedures 11 7 DVT 1 1 * Operator Error in 2 nails (held Magnet backward)
12 Stature: Failure to Achieve Full Goal N = 17 (36 nails) # nails # Pts Dense Regenerate Preventing Goal 3* 2* Pt. Requested to Stop Lengthening 14 7 Failed to Achieve Pre-op Goal * Drive Mechanism Broke, 1 st Generation PRECICE
13 Discussion Excellent Rate Control Bi-directional feature used in one patient to acutely shorten Very Versatile Implant Inherent Risks of Lengthening Remain
14 Discussion 3 nails broke in 2 patients at the weld (role of premature WB?) Break at weld 4 nails ceased in late distraction phase in 3 pts: break in motor/drive shaft junction Drive shaft junction
15 Fracture of Left femur rod at the Weld with Full Weight Bearing Aug 14, 2012
16 Broken Rod removed and replaced with locked IM rod: FAN Aug 14, 2012
17 Significance Results of this study helped lead to redesign Precice-2 set for launch in US soon Precice-2 has no welds (4x stronger) Motor to driveshaft connection strengthened 3x Lengthening amount increased to 8cms Smaller diameter device also available (8.5mm) PRECICE-2 PRECICE-1
18 THANK YOU
19 Ellipse Technologies Irvine, California FDA approved lengthening nail: 2011 Stuart Green, MD
20 ERC Device <55mm ERC must be within 55mm of magnet
21 16 y.o. boy; Post-traumatic Growth Arrest June 14, 2010
22 8 week Follow up x-rays: 6.5cms Jan 31, 2012
23 Varus closing wedge osteotomy distal femur; decompression peroneal nerve Feb 7, 2012 Feb 8, 2012
24 Final Alignment: 3 months post op March 1, 2012
25 Unicameral Bone Cyst; Humeral Shortening 6.5cms March 29, 2012
26 Follow up x-rays July 26, 2012 Oct 1, 2012
27 12 y.o. girl; Congenital Short Femur: Genu Valgum June 11, 2012 July 17, 2012 Aug 13, 2012
28 Complications: Unilateral Cases
29 CFD and FH: 8cms LLD: combined Femur and Tibia Lengthening April 9, 2012
30 Knee Subluxation: resolved with PT Aug, 13, 2012 Sept 13, 2012
31 CFD 13 y.o. girl (previous ex fix lengthening) June 13, 2012 July 6, 2012
32 Spontaneous Intertrochanteric Fracture:Rx ORIF July 24, 2012
33 Failure of Bone Formation: Bone Grafting Feb. 4, 2013
34 Bilateral Femur Lengthening April 2, 2012 May 7, 2012
35 Follow up x-rays: 6.5cms Femur Lengthening achieved July 24, 2012
36 5cms Bilateral Tibial lengthening: Total Height Gain 11.5cms May 1, 2012
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