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Dual Rods and Submuscular Rod Placement Reduce Complications and Unplanned Surgeries in the Growing Spine: Analysis of 910 Surgeries in 143 Patients Shay.

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Presentation on theme: "Dual Rods and Submuscular Rod Placement Reduce Complications and Unplanned Surgeries in the Growing Spine: Analysis of 910 Surgeries in 143 Patients Shay."— Presentation transcript:

1 Dual Rods and Submuscular Rod Placement Reduce Complications and Unplanned Surgeries in the Growing Spine: Analysis of 910 Surgeries in 143 Patients Shay Bess, Behrooz Akbarnia, George Thompson, Paul Sponseller, David Skaggs, Suken Shah, Hazem Elsabaie, Oheneba Boachie-Adjei, Sarah Canale, Connie Poe-Kocher and the Growing Spine Study Group 2nd International Congress Early Onset Scoliosis and Growing Spine Montreal November 2008

2 ICEOS 2nd Annual Meeting Authors Disclosure Information
Presenter Shay Bess Nuvasive (e), Pioneer (b), Alphatec (b), Stryker (d) Co-Authors Behrooz Akbarnia DePuy; A Johnson & Johnson Company (a,b,d,e),K2M (b,d,e), Nuvasive (a,b,c,d), Stryker (d),Ellipse Technologies,Inc (b), Allez Spine (c),Medtronic Sofamor Danek (a) George Thompson DePuy ,A Johnson & Johnson Company (b,d),Synthes (b,d), Medtronic Sofamor Danek (a) ,Zimmer (a) Paul Sponseller DePuy ,A Johnson & Johnson Company (a,b,d), Globus Medical (e) David Skaggs DePuy Spine (d), Stryker (b,d), Medtronic (a,b,d) Suken Shah DePuy Spine (a,b,e) Hazem Elsabaie No Relationships Oheneba Boachie-Adjei DePuy Spine (a,d,e), Osteotech (a,b),K2M(a,b,e) Axial biotech (a) Sarah Canale No Relationships Connie Poe-Kocher No Relationships (a) Grants/Research Support (b) Consultant (c) Stock/Shareholder (d) Speakers’ Bureau (e) Other Financial Support

3 Introduction Treatment Scoliosis Growing Spine= Challenging
Observation Curve progression Arrest pulmonary development Cast treatment Skin breakdown Inhibit chest wall development Early Fusion Inhibit trunk and thoracic development Fusionless Technology Allow thoracic and pulmonary development Growing Rod Technique (GR) Unacceptably high complication rates? Used with permission from Children's Hospital Los Angeles, Inc

4 Purpose: Materials and Methods
Evaluate Complications GR Treatment Clinical Radiographic Minimum 2 yr F/U Initial GR implant Multi-center, Retrospective Treatment Groups Construct type Single Rod (SI) Dual rod (DU) Implant placement Subcutaneous (SQ) Submuscular (MU) Used with permission from Children's Hospital Los Angeles, Inc

5 Materials and Methods Complications
Wound (superficial, deep infection, etc) Implant (rod/fixation failure, prominence, etc) Alignment (curve progression, PJK, DJK, etc) Medical/Other (GI, pulmonary, etc) Surgical procedures Planned (PLAN = anticipated surgery due to routine GR treatment) Unplanned (UNPLAN= surgery due to complications)

6 Results: Demographics & Treatment Groups
143 patients ( ) Avg. age =6.1 years (range, yrs) 910 GR surgeries 13.3 levels (7-18) 6.4 procedures/ pt (2-15) 4.5 lengthening/ pt (0-13) Final fusion=53 pts (37%) Follow up=59.4 mo. ( mo.) Treatment groups Construct type (NS) SI; n=73 DU; n=70 Subgroups (*=p<0.05) SI SQ; n=17* SI MU; n=55 DU SQ; n=35 DU MU; n=35

7 Results: Diagnosis

8 Results: Total Procedures and Complications
Single vs. Dual Rod SI (n=73) DU (n=70) p value Total (n=143) Total Surgeries; avg (range) 447; 6.1 (3-13) 463; 6.6 (2-15) NS 910; 6.4 (2-15) Total complications 94 83 177 Total pts with complication 43 38 81 Percent pts with complication 59% 54% 57% Complications per patient (range) 1.3 (0-7) 1.2 (0-7) Complications per surgery 0.21 0.18 0.19 Total UNPLAN 42 32 74 Total PLAN 405 431 836 Ratio PLAN to UNPLAN 9.6:1 13.5:1 11.3:1 Complications leading to UNPLAN 45% 38% 42%

9 Results: Wound Complications
SI (n=73) DU (n=70) Total (n=143) Total Wound Complications (pts;total;avg) 8;9;0.12 15;21;0.3 23;30;0.21 % Wound Complication 11% 21% 16% Superficial; Deep Infections 0*; 6 6*; 8 6; 14 UNPLAN (pts;total) 7;10 9;19 16;29 Ratio Wound Problem: UNPLAN <1 1.1 1.03 SI-SQ (n=17) SI-MU (n=55) DU-SQ (n=35) DU-MU (n=35) Total Wound Complications (pts;total;avg) 2;2;0.12 5;6;0.11 11*;16;0.5 4*;5;0.1 % Wound Complication 11% 9% 31%* 11%* Superficial; Deep Infections 0;1 0; 4 4; 6 2; 3 UNPLAN (pts/total) 1;1 5;8 5;12 4;7 Ratio Wound Problem: UNPLAN 2 <1 1.3 *=p<0.05

10 Results: Wound Complications

11 Results: Implant Complications
SI (n=73) DU (n=70) Total (n=143) Total Implant Complications (pts;total;avg) 34;64;0.88 29;42;0.6 63;106;0.74 % Pts Implant Complication 46% 41% 44% Hook Loss; Screw Loss; Rod Fracture; Prominence; (total) 27*; 0; 30; 2 10*; 5; 22; 4 37; 5; 52; 6 UNPLAN (pts;total;avg) 19*;28*;0.4* 7*;10*;0.15* 26;38;.28 Ratio Implant Problem: UNPLAN 2.3 4.2 2.8 SI-SQ (n=17) SI-MU (n=55) DU-SQ (n=35) DU-MU Total Implant Complications (pts;total;avg) 9;18;1.1 24;25;0.8 15;27;0.8 14;15;0.4 % Pts Implant Complication 53% 44% 43% 40% Hook Loss; Screw Loss; Rod Fracture; Prominence; (total) 8; 0; 7; 1 19; 0; 22; 1 6; 5; 11; 4* 4; 0; 11; 0* UNPLAN (pts;total;avg) 6;9;0.5 12;19;0.4 6*;9*;0.3* 1*;1*;0.03* Ratio Implant Problem: UNPLAN 2 1.3 3 15* *=p<0.05

12 Results: Implant Complications

13 Results: Alignment Complications
SI (n=73) DU (n=70) Total (n=143) Total Alignment Complications (pts;total;avg;range) 4; 4; 0.05; 0-1 6; 7; 0.1; 0-2 10; 11; 0.08; 0-2 % Pts with Alignment Complication 6% 9% 7% Junctional Kyphosis; Curve Progression; Other; (total) 1; 0; 3 2; 4; 0 3; 4; 3 UNPLAN (pts;total;avg;range) 3; 3; 0.04; 0-1 2; 3; 0.04; 0-2 5; 6; 0.04; 0-2 Ratio Implant Problem: UNPLAN 1.3 2.3 1.8 *=p<0.05 SI-SQ (n=17) SI-MU (n=55) DU-SQ (n=35) DU-MU Total Alignment Complications (pts;total;avg;range) 2;2; 0.12; 0-1 1;1; 0.02; 0-1 3;3; 0.09; 0-1 3;4; 0.1; 0-2 % Pts with Alignment Complication 12% 2% 8% Junctional Kyphosis; Curve Progression; Other; (total) 0; 0; 2 1; 0; 0 1; 1; 1 1; 3; 0 UNPLAN (pts;total;avg;range) 1; 1; 0.03; 0-1 1; 2; 0.06; 0-2 Ratio Implant Problem: UNPLAN 1 NA 3 *=p<0.05

14 Results: Medical and Other Complications
SI (n=73) DU (n=70) Total (n=143) Total Medical & Other Complications (pts;total;avg;range) 11; 15; 0.21; 0-2 6; 7; 0.1; 0-3 17; 22; 0.15; 0-3 % Pts with Medical Complication 15% 8% 12% Pulmonary 8 2 10 Dural Tear 3 1 4 Other (hematoma, GI, EBL) UNPLAN Ratio Implant Problem: UNPLAN NA

15 Results Kaplan-Meier Survival Analysis
Total complications vs. Procedures 50% survivorship at 7 surgeries Wound Complications vs. Procedures 90% survivorship at 7 surgeries 40% survivorship at 13 surgeries Odds Ratio: Complication vs. Procedure 24% increased complication risk each additional procedure (Odds Ratio=1.24, 95% Confidence Interval: 1.07, 1.44, p=0.005) Odds Ratio: Complication vs. Age 13% decrease complication risk each year increased age initial surgery (Odds Ratio=0.87, 95% Confidence Interval: 0.75, 1.00, p=0.057).

16 Conclusions Growing Rod Complications Procedure vs. Treatment
Acceptable complication rate per procedure? Comparable to AIS (Carreon et al JBJS 2007) 19% vs. 15.4% Complication rate correlates with number procedures Anticipate complication Council parents

17 Conclusions Complications ≠ Surgery Complications manageable by PLAN
Steps to minimize Complications UNPLAN Dual Rods Reduce implant complications Reduce implant UNPLAN Submuscular Rods Reduce wound complications

18 ICEOS 2nd Annual Meeting
Thank You ICEOS 2nd Annual Meeting Montreal November 2008

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