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Is There an Improvement in Quality of Life with Early Onset Scoliosis Managed with Traditional Growing Rods Converted to Magnetically Controlled Growing Rods?
460
Abstracts / Spine Deformity 5 (2017) 440e465
costs, rod breakage rates, months between lengthenings, and TGR lengthenings setting of care. Conclusion: GGS resulted in fewer invasive surgeries and deep SSIs than TGR and lower cumulative costs per patient than both MCGR and TGR over a 6-year episode of care. The analysis did not account for family disruption, pain, psychological distress, or compromised health-related quality of life associated with invasive TGR lengthenings. Author disclosures: Scott Luhmann: Medtronic Sofamor Danek, Stryker, Nuvasive; Orthopediatrics; Globus Medical; Wolters Kluwer. Eoin McAughey: Covance. Ackerman Stacey: Covance. David Bumpass: North American Spine Society; Medtronic; Acuity Surgical. Richard McCarthy: Medtronic.
treatments. A recent study of 12 growing rod graduates, who underwent lengthening treatment over mean 8.8 years, reported scores from 84-115 out of 120 in multiple HRQoL domains. Methods: EOSQ collected from 31 patients undergoing MCGR and TGR pre- and 1 and 2 yr postop. Scores in individual domains were compared between both groups. Results: 31 patients met the criteria, N518 MCGR, N513 TGR. Diagnoses were distributed evenly between both groups: idiopathic (8), NM (8), congenital (7), syndromics (6) - Prader-Wili, Larsen, DiGeorge, Freeman-Shelton, Klippel-Feil, and Conradi-Hunermann, NF (1), and arthrogryposis (1). Both groups have similar age at first surgery ^aV‘‘ 6 and 6.6 yo (p50.641) and also preop major curves ^aV‘‘ 72.5 and 86.5 (p50.116). At preop, no differences in overall total score plus 10 domains for both groups were found; financial impact was the only domain where there was a significantly greater impact by the MCGR compared TGR (mean 70.8 vs 41.7, p50.024). Similar results were found at 1 year f/u, with the exception of parental impact domain, where TGR scored lower than MCGR (60 vs 80, p50.008). A subset of the cohort has 2 year f/u, N516, 8 MCGR, 8 TGR, where there was no differences in scores between the two groups. Conclusion: While clinicians anticipate a higher HRQoL when the number of surgical procedures decrease, our study shows no difference between the groups at f/u. However, as previously shown in the f/u study of TGR graduates, EOSQ scores are higher at 8.8 yr f/u than the 1 and 2 yr scores reported here, suggesting that treatment method may not matter in the long term. Also patients completing treatment may score higher than those still early in treatment protocol for reasons still to be determined. Author disclosures: Dong-Phuong Tran: none. Charles Johnston: Orthopedics Journal of Childrens Orthopedics; Pediatric Orthopaedic Society of North America; Scoliosis Research Society; Medtronic Sofamor Danek; Saunders/Mosby-Elsevier.
Paper #39
Paper #40
Short term HRQoL results in MCGR and TGR patients divergent from long term EOSQ results in TGR graduates Dong-Phuong Tran, Charles Johnston
Is There an Improvement in Quality of Life with Early Onset Scoliosis Managed with Traditional Growing Rods Converted to Magnetically Controlled Growing Rods? Jennifer Bauer, Petya Yorgova, Geraldine Neiss, Kenneth J. Rogers, Peter F. Sturm, Paul Sponseller, Scott Luhmann, Jeff Pawelek, A. Suken Shah
Summary: Using the validated EOSQ24 collected on 31 MCGR and traditional growing rod (TGR) patients, there was no difference in multiple domain scores between the two groups at preop and postop. Hypothesis: HRQoL scores are anticipated to be higher in MCGR patients due to fewer surgical lengthening procedures. Design: IRB approved retrospective review from a single institution. Introduction: Patient-reported EOSQ assesses the impact of multiple surgical lengthening procedures in patients undergoing MCGR and TGR
Preop N Age at surgery Total score General health Pain/discomfort Pulmonary function Transfer Physical function Daily living Fatigue/Energy level Emotion Parental impact Financal impact Satisfaction
Summary: Introduction of magnetically controlled growing rods (MCGR) for early onset scoliosis treatment was anticipated to improve quality of life for patients and their families. A cohort of patients converted from traditional growing rods to MCGR may be best suited to detect this improvement and have not previously been examined. Using the validated
1 Year f/u
2 Year f/u
MCGR
TGR
P
MCGR
TGR
P
MCGR
TGR
P
18 6 92.4 68.8 75.7 86.1 76.4 69.9 56.3 67.4 80.6 71.9 70.8 64.6
13 6.4 86.5 68.8 70.8 81.3 77.1 64.6 47.9 72.9 68.8 59.2 41.7 69.8
0.810 0.271 0.271 0.483 0.590 0.982 0.606 0.468 0.620 0.408 0.077 0.024 0.534
18 N/A 95.8 73.6 72.9 86.1 83.3 72.7 54.7 75.0 77.8 80.0 69.4 72.9
9 N/A 89.9 69.4 63.9 93.1 63.9 68.5 48.6 76.4 73.6 60.0 66.7 65.3
N/A 0.243 0.493 0.356 0.451 0.356 0.958 0.568 O0.999 0.895 0.008 0.893 0.440
8 N/A 84.4 71.9 65.6 79.7 68.8 64.6 43.8 59.4 64.1 61.9 53.1 62.5
8 N/A 90.9 71.9 65.6 92.2 68.8 67.7 53.1 81.3 81.3 62.5 68.8 68.8
N/A 0.292 0.957 0.957 0.629 O0.999 0.711 0.526 0.121 0.081 0.792 0.304 O0.999
Abstracts / Spine Deformity 5 (2017) 440e465
EOSQ-24 Domain
general health pain/discomfort pulmonary function transfer physical function daily living fatigue/energy level emotion parental burden financial burden satisfaction child satisfaction parent satisfaction
MCGR
TGR
461
Conversion
1st EOSQ
final EOSQ
1st EOSQ
final EOSQ
1st EOSQ
final EOSQ
72.9 74.8 84.6 77.0 63.4 52.6 72.2 78.1 68.3 64.5 67.8 67.8 67.4
73.9 76.1 88.4 84.2 68.4 54.7 76.4 78.8 72.7 76.6 70.7 69.4 72.1
73.6 71.5 88.0 75.5 71.9 59.5 71.7 75.6 67.4 71.3 66.1 65.1 66.4
78.2 70.6 88.1 72.3 73.1 62.7 68.0 73.0 70.8 77.0 68.0 67.1 68.6
71.7 77.3 83.9 78.1 74.4 49.6 72.6 74.6 68.3 61.7 67.2 66.4 68.3
73.0 74.2 83.1 75.0 77.9 53.3 69.5 73.0 72.7 73.3 66.5 65.3 66.4
EOSQ-24, no HRQoL differences were detected between TGR, MCGR, or converted patient cohorts. Hypothesis: Improvement in health-related quality of life (HRQoL), specifically in Family Burden and Satisfaction, is expected for patients who convert from TGR to MCGR. Design: Retrospective review of prospective multi-center data. Introduction: Modern treatment of early onset scoliosis (EOS) includes traditional growing rods (TGR) and magnetically controlled growing rods (MCGR). MCGR innovation has been expected to improve family and patient burden by avoiding frequent return to the operating room. At least one study has showed minor HRQoL differences between TGR and MCGR (Doany ME, et al.), but no prior studies have specifically investigated a cohort of converted patients. Methods: A multi-center EOS database was queried for all patients treated with TGR, MCGR, and those converted from TGR to MCGR who had at least one pre-and one post-treatment EOSQ-24. Data on demographics, diagnoses, major curve size, and complications, as well as EOSQ-24 domain scores were collected. Post hoc sample size analysis was included in statistical analysis. Results: There were 156 TGR, 114 MCGR, and 32 conversion patients, with an overall average of 2.0yr between first and final EOSQ-24 data. There was no significant difference in outcome in any EOSQ-24 domain between the three cohorts, including parental burden domain (TGR+4.2, MCGR+4.1, conversion+4.5; p50.99). A sample size analysis found the data powered to 0.94 (94%). There was also no difference after controlling for neuromuscular patients, major curve size, or by grouping MCGR+conversion group versus TGR. Conclusion: Although patient families and their surgeons may subjectively report improved QoL after conversion from frequent surgical TGR lengthenings to in-office MCGR lengthenings, these improvements were not evident in HRQoL surveys. While the EOSQ-24 is a well-validated
Change in final EOSQ-first EOSQ EOSQ-24 Domain
MCGR
TGR
Convers.
general health pain/discomfort pulmonary function transfer physical function daily living fatigue/energy level emotion parental burden financial burden satisfaction
1.11 1.59 4.05 7.3 5.23 1.79 4.62 0.35 4.07 8.95 3.41
4.65 -0.76 0.1 -3.17 1.43 3.39 -5.1 -1.46 4.21 6.33 2.2
0 -3.13 -1.21 -3.13 0.64 7.08 -4.03 -1.29 4.46 13.39 0.86
EOS metric, it may not be able to overcome the baseline QoL associated with the diagnosis itself to detect differences made by treatment, if they exist, or perhaps, the improvement in QoL must be assessed over a longer interval than 2 years to assess meaningful change. Author disclosures: Jennifer Bauer: none. Petya Yorgova: none. Geraldine Neiss: none. Kenneth J. Rogers: none. Peter F. Sturm: DePuy Spine; Journal of Children’s Orthopaedics; Scoliosis Research Society; Pediatric Orthopaedic Society of North America; Biomet; Depuy Synthes; Medtronic; DePuy, A Johnson & Johnson Company; Ellipse Technologies; Medtronic Sofamor Danek; Nuvasive. Paul Sponseller: Oakstone Medical; Journal of Bone and Joint Surgery; Scoliosis Research Society; Depuy Synthes; DePuy Synthes Spine; DePuy, A Johnson & Johnson Company; Globus Medical; Globus. Scott Luhmann: Medtronic Sofamor Danek, Stryker, Nuvasive; Orthopediatrics; Globus Medical; Wolters Kluwer. Jeff Pawelek: San Diego Spine Foundation; Growing Spine Foundation; Nuvasive. Suken A. Shah: AAOS; Pediatric Orthopaedic Society of North America; Setting Scoliosis Straight Foundation; Scoliosis Research Society; Depuy Synthes; DePuy Synthes Spine; K2M; Nuvasive; Stryker; Ethicon; Arthrex, Inc; Globus Medical.
Paper #41 Two Year HRQOL Measures are Similar Between Magnetically-Controlled Growing Rod Patients and Traditional Growing Rod Patients David Skaggs, Behrooz Akbarnia, Jeff Pawelek, Hiroko Matsumoto, Tricia St. Hilaire, Peter F. Sturm, Francisco Javier Sanchez Perez-Grueso, Scott Luhmann, Paul Sponseller, John Smith, Klane White, Michael Vitale, Children’s Spine Study Group, Growing Spine Study Group Summary: Despite having lower HRQoL domain scores pre-operatively, EOS patients treated with magnetically-controlled growing (MCGR) had similar EOSQ-24 domain scores after two years of treatment compared to patients treated with traditional growing rods (TGR). Hypothesis: MCGR patients have higher postoperative HRQoL scores compared to TGR patients. Design: Multicenter retrospective cohort study. Introduction: Since the introduction of magnetically-controlled growing rods (MCGR), patients with progressive early-onset scoliosis (EOS) have seen a reduction in the number of surgeries compared to the traditional growing rod (TGR). However, little is known about whether there is an improvement in health-related quality of life (HRQoL) between these two surgical techniques. Methods: We are reporting HRQoL results of a multicenter retrospective cohort study that compared MCGR and TGR patients treated between August 2008 and July 2017. The EOSQ-24 questionnaire was used to measure HRQOL. The EOSQ-24 was administered at pre-op, 6, 12 and 24
Abstracts / Spine Deformity 5 (2017) 440e465
costs, rod breakage rates, months between lengthenings, and TGR lengthenings setting of care. Conclusion: GGS resulted in fewer invasive surgeries and deep SSIs than TGR and lower cumulative costs per patient than both MCGR and TGR over a 6-year episode of care. The analysis did not account for family disruption, pain, psychological distress, or compromised health-related quality of life associated with invasive TGR lengthenings. Author disclosures: Scott Luhmann: Medtronic Sofamor Danek, Stryker, Nuvasive; Orthopediatrics; Globus Medical; Wolters Kluwer. Eoin McAughey: Covance. Ackerman Stacey: Covance. David Bumpass: North American Spine Society; Medtronic; Acuity Surgical. Richard McCarthy: Medtronic.
treatments. A recent study of 12 growing rod graduates, who underwent lengthening treatment over mean 8.8 years, reported scores from 84-115 out of 120 in multiple HRQoL domains. Methods: EOSQ collected from 31 patients undergoing MCGR and TGR pre- and 1 and 2 yr postop. Scores in individual domains were compared between both groups. Results: 31 patients met the criteria, N518 MCGR, N513 TGR. Diagnoses were distributed evenly between both groups: idiopathic (8), NM (8), congenital (7), syndromics (6) - Prader-Wili, Larsen, DiGeorge, Freeman-Shelton, Klippel-Feil, and Conradi-Hunermann, NF (1), and arthrogryposis (1). Both groups have similar age at first surgery ^aV‘‘ 6 and 6.6 yo (p50.641) and also preop major curves ^aV‘‘ 72.5 and 86.5 (p50.116). At preop, no differences in overall total score plus 10 domains for both groups were found; financial impact was the only domain where there was a significantly greater impact by the MCGR compared TGR (mean 70.8 vs 41.7, p50.024). Similar results were found at 1 year f/u, with the exception of parental impact domain, where TGR scored lower than MCGR (60 vs 80, p50.008). A subset of the cohort has 2 year f/u, N516, 8 MCGR, 8 TGR, where there was no differences in scores between the two groups. Conclusion: While clinicians anticipate a higher HRQoL when the number of surgical procedures decrease, our study shows no difference between the groups at f/u. However, as previously shown in the f/u study of TGR graduates, EOSQ scores are higher at 8.8 yr f/u than the 1 and 2 yr scores reported here, suggesting that treatment method may not matter in the long term. Also patients completing treatment may score higher than those still early in treatment protocol for reasons still to be determined. Author disclosures: Dong-Phuong Tran: none. Charles Johnston: Orthopedics Journal of Childrens Orthopedics; Pediatric Orthopaedic Society of North America; Scoliosis Research Society; Medtronic Sofamor Danek; Saunders/Mosby-Elsevier.
Paper #39
Paper #40
Short term HRQoL results in MCGR and TGR patients divergent from long term EOSQ results in TGR graduates Dong-Phuong Tran, Charles Johnston
Is There an Improvement in Quality of Life with Early Onset Scoliosis Managed with Traditional Growing Rods Converted to Magnetically Controlled Growing Rods? Jennifer Bauer, Petya Yorgova, Geraldine Neiss, Kenneth J. Rogers, Peter F. Sturm, Paul Sponseller, Scott Luhmann, Jeff Pawelek, A. Suken Shah
Summary: Using the validated EOSQ24 collected on 31 MCGR and traditional growing rod (TGR) patients, there was no difference in multiple domain scores between the two groups at preop and postop. Hypothesis: HRQoL scores are anticipated to be higher in MCGR patients due to fewer surgical lengthening procedures. Design: IRB approved retrospective review from a single institution. Introduction: Patient-reported EOSQ assesses the impact of multiple surgical lengthening procedures in patients undergoing MCGR and TGR
Preop N Age at surgery Total score General health Pain/discomfort Pulmonary function Transfer Physical function Daily living Fatigue/Energy level Emotion Parental impact Financal impact Satisfaction
Summary: Introduction of magnetically controlled growing rods (MCGR) for early onset scoliosis treatment was anticipated to improve quality of life for patients and their families. A cohort of patients converted from traditional growing rods to MCGR may be best suited to detect this improvement and have not previously been examined. Using the validated
1 Year f/u
2 Year f/u
MCGR
TGR
P
MCGR
TGR
P
MCGR
TGR
P
18 6 92.4 68.8 75.7 86.1 76.4 69.9 56.3 67.4 80.6 71.9 70.8 64.6
13 6.4 86.5 68.8 70.8 81.3 77.1 64.6 47.9 72.9 68.8 59.2 41.7 69.8
0.810 0.271 0.271 0.483 0.590 0.982 0.606 0.468 0.620 0.408 0.077 0.024 0.534
18 N/A 95.8 73.6 72.9 86.1 83.3 72.7 54.7 75.0 77.8 80.0 69.4 72.9
9 N/A 89.9 69.4 63.9 93.1 63.9 68.5 48.6 76.4 73.6 60.0 66.7 65.3
N/A 0.243 0.493 0.356 0.451 0.356 0.958 0.568 O0.999 0.895 0.008 0.893 0.440
8 N/A 84.4 71.9 65.6 79.7 68.8 64.6 43.8 59.4 64.1 61.9 53.1 62.5
8 N/A 90.9 71.9 65.6 92.2 68.8 67.7 53.1 81.3 81.3 62.5 68.8 68.8
N/A 0.292 0.957 0.957 0.629 O0.999 0.711 0.526 0.121 0.081 0.792 0.304 O0.999
Abstracts / Spine Deformity 5 (2017) 440e465
EOSQ-24 Domain
general health pain/discomfort pulmonary function transfer physical function daily living fatigue/energy level emotion parental burden financial burden satisfaction child satisfaction parent satisfaction
MCGR
TGR
461
Conversion
1st EOSQ
final EOSQ
1st EOSQ
final EOSQ
1st EOSQ
final EOSQ
72.9 74.8 84.6 77.0 63.4 52.6 72.2 78.1 68.3 64.5 67.8 67.8 67.4
73.9 76.1 88.4 84.2 68.4 54.7 76.4 78.8 72.7 76.6 70.7 69.4 72.1
73.6 71.5 88.0 75.5 71.9 59.5 71.7 75.6 67.4 71.3 66.1 65.1 66.4
78.2 70.6 88.1 72.3 73.1 62.7 68.0 73.0 70.8 77.0 68.0 67.1 68.6
71.7 77.3 83.9 78.1 74.4 49.6 72.6 74.6 68.3 61.7 67.2 66.4 68.3
73.0 74.2 83.1 75.0 77.9 53.3 69.5 73.0 72.7 73.3 66.5 65.3 66.4
EOSQ-24, no HRQoL differences were detected between TGR, MCGR, or converted patient cohorts. Hypothesis: Improvement in health-related quality of life (HRQoL), specifically in Family Burden and Satisfaction, is expected for patients who convert from TGR to MCGR. Design: Retrospective review of prospective multi-center data. Introduction: Modern treatment of early onset scoliosis (EOS) includes traditional growing rods (TGR) and magnetically controlled growing rods (MCGR). MCGR innovation has been expected to improve family and patient burden by avoiding frequent return to the operating room. At least one study has showed minor HRQoL differences between TGR and MCGR (Doany ME, et al.), but no prior studies have specifically investigated a cohort of converted patients. Methods: A multi-center EOS database was queried for all patients treated with TGR, MCGR, and those converted from TGR to MCGR who had at least one pre-and one post-treatment EOSQ-24. Data on demographics, diagnoses, major curve size, and complications, as well as EOSQ-24 domain scores were collected. Post hoc sample size analysis was included in statistical analysis. Results: There were 156 TGR, 114 MCGR, and 32 conversion patients, with an overall average of 2.0yr between first and final EOSQ-24 data. There was no significant difference in outcome in any EOSQ-24 domain between the three cohorts, including parental burden domain (TGR+4.2, MCGR+4.1, conversion+4.5; p50.99). A sample size analysis found the data powered to 0.94 (94%). There was also no difference after controlling for neuromuscular patients, major curve size, or by grouping MCGR+conversion group versus TGR. Conclusion: Although patient families and their surgeons may subjectively report improved QoL after conversion from frequent surgical TGR lengthenings to in-office MCGR lengthenings, these improvements were not evident in HRQoL surveys. While the EOSQ-24 is a well-validated
Change in final EOSQ-first EOSQ EOSQ-24 Domain
MCGR
TGR
Convers.
general health pain/discomfort pulmonary function transfer physical function daily living fatigue/energy level emotion parental burden financial burden satisfaction
1.11 1.59 4.05 7.3 5.23 1.79 4.62 0.35 4.07 8.95 3.41
4.65 -0.76 0.1 -3.17 1.43 3.39 -5.1 -1.46 4.21 6.33 2.2
0 -3.13 -1.21 -3.13 0.64 7.08 -4.03 -1.29 4.46 13.39 0.86
EOS metric, it may not be able to overcome the baseline QoL associated with the diagnosis itself to detect differences made by treatment, if they exist, or perhaps, the improvement in QoL must be assessed over a longer interval than 2 years to assess meaningful change. Author disclosures: Jennifer Bauer: none. Petya Yorgova: none. Geraldine Neiss: none. Kenneth J. Rogers: none. Peter F. Sturm: DePuy Spine; Journal of Children’s Orthopaedics; Scoliosis Research Society; Pediatric Orthopaedic Society of North America; Biomet; Depuy Synthes; Medtronic; DePuy, A Johnson & Johnson Company; Ellipse Technologies; Medtronic Sofamor Danek; Nuvasive. Paul Sponseller: Oakstone Medical; Journal of Bone and Joint Surgery; Scoliosis Research Society; Depuy Synthes; DePuy Synthes Spine; DePuy, A Johnson & Johnson Company; Globus Medical; Globus. Scott Luhmann: Medtronic Sofamor Danek, Stryker, Nuvasive; Orthopediatrics; Globus Medical; Wolters Kluwer. Jeff Pawelek: San Diego Spine Foundation; Growing Spine Foundation; Nuvasive. Suken A. Shah: AAOS; Pediatric Orthopaedic Society of North America; Setting Scoliosis Straight Foundation; Scoliosis Research Society; Depuy Synthes; DePuy Synthes Spine; K2M; Nuvasive; Stryker; Ethicon; Arthrex, Inc; Globus Medical.
Paper #41 Two Year HRQOL Measures are Similar Between Magnetically-Controlled Growing Rod Patients and Traditional Growing Rod Patients David Skaggs, Behrooz Akbarnia, Jeff Pawelek, Hiroko Matsumoto, Tricia St. Hilaire, Peter F. Sturm, Francisco Javier Sanchez Perez-Grueso, Scott Luhmann, Paul Sponseller, John Smith, Klane White, Michael Vitale, Children’s Spine Study Group, Growing Spine Study Group Summary: Despite having lower HRQoL domain scores pre-operatively, EOS patients treated with magnetically-controlled growing (MCGR) had similar EOSQ-24 domain scores after two years of treatment compared to patients treated with traditional growing rods (TGR). Hypothesis: MCGR patients have higher postoperative HRQoL scores compared to TGR patients. Design: Multicenter retrospective cohort study. Introduction: Since the introduction of magnetically-controlled growing rods (MCGR), patients with progressive early-onset scoliosis (EOS) have seen a reduction in the number of surgeries compared to the traditional growing rod (TGR). However, little is known about whether there is an improvement in health-related quality of life (HRQoL) between these two surgical techniques. Methods: We are reporting HRQoL results of a multicenter retrospective cohort study that compared MCGR and TGR patients treated between August 2008 and July 2017. The EOSQ-24 questionnaire was used to measure HRQOL. The EOSQ-24 was administered at pre-op, 6, 12 and 24