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Which Factors Predict Shoulder Asymmetry in Patients with Lenke Type 1 and 3 Curves following Pedicle Screw Instrumentation?
160S
Proceedings of the NASS 29th Annual Meeting / The Spine Journal 14 (2014) 1S–183S
had low to strong correlation. Disease specific PROs (Back Pain and ODI) have stronger correlations than general health and quality of life measures (SF-12 PCS and MCS). The responsiveness of questionnaires also varies with the method of data collection. Large scale studies need to be carried out to determine which method of data collection is more effective. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
P133. The Incidence of Symptomatic Adjacent Segment Disease Requiring Treatment: Cervical Arthroplasty versus ACDF Jacqueline Myer1, William Beutler, MD, FACS2, Jeffrey R. McConnell, MD3, James G. Lindley, Jr., MD4; 1Globus Medical Inc., Audubon, PA, US; 2 Pennsylvania Spine Institute, Harrisburg, PA, US; 3OAA Orthopaedic Specialists, Allentown, PA, US; 4Neurological Institute of Savannah and Center for Spine, Savannah, GA, US
http://dx.doi.org/10.1016/j.spinee.2014.08.385
BACKGROUND CONTEXT: The rate of subsequent adjacent level surgery for patients treated with SECUREÒ-C versus that of anterior cervical discectomy and fusion (ACDF) in the SECUREÒ-C IDE study was compared at long-term follow-up. STUDY DESIGN/SETTING: A prospective, randomized pivotal IDE study of the SECUREÒ-C Cervical Artificial Disc was conducted at 18 sites in the United States. PATIENT SAMPLE: Three hundred eighty patients were enrolled and treated in the study. Data are presented on 291 patients who were randomized and treated in the study: 151 SECUREÒ-C and 140 ACDF patients. METHODS: Criteria for study participation included symptomatic cervical disc disease in one vertebral level between C3 and C7, defined by neck and/or arm pain, herniated nucleus pulposus, radiculopathy or myelopathy, and other conditions as specified in the study protocol. All study patients have a preoperative Neck Disability Index (NDI) score of at least 30 (as a percentage of a 50-point total), have completed at least 6 weeks of conservative therapy, and are between 18 and 60 years of age. Enrolled patients were randomized 1:1 to either the investigational SECUREÒ-C disc or control ACDF, with the exception of the first five patients treated at each site who were nonrandomized and received SECUREÒ-C. RESULTS: Of the SECUREÒ-C patients, four underwent additional surgery at adjacent levels and were treated as follows: two-level foraminotomy at an adjacent level and a level below the adjacent level at 11.9 months postop; two-level fusion at 16.9 months (index and adjacent level); cervical disc replacement at an adjacent level at 17.3 months; posterior decompression at the index and an adjacent level at 19.2 months. Sixteen of the ACDF patients were surgically treated at an adjacent level or multiple levels at various postoperative time periods. Between 7 weeks and 3 years postop: seven ACDF patients underwent an adjacent level fusion and one patient had two adjacent levels fused. Between 3 years and 6 years postop, five patients had one adjacent level fused, two patients had two additional levels fused (adjacent level and level above adjacent level) and one patient had an adjacent level treated with an artificial disc. Cumulatively, by 6 years post-op, the rate of adjacent level surgery for randomized patients was 2.6% for the SECUREÒ-C group compared to 11.4% for ACDF. CONCLUSIONS: The rate of surgical treatment for adjacent segment disease was substantially lower in the randomized SECUREÒ-C group compared to the ACDF group. These results suggest that treatment of symptomatic cervical disc disease with motion preservation devices such as SECUREÒ-C may help reduce the risk of developing symptomatic adjacent segment disease that requires surgical treatment. FDA DEVICE/DRUG STATUS: SECURE-C Cervical Artificial Disc (Approved for this indication).
P132. Which Factors Predict Shoulder Asymmetry in Patients with Lenke Type 1 and 3 Curves following Pedicle Screw Instrumentation? Meric Enercan, MD1, Sinan Kahraman, MD1, Tunay Sanli, MA1, Bahadir Gokcen, MD1, Cagatay Ozturk, MD2, Ufuk Talu, MD3, Ahmet Alanay, MD4, Azmi Hamzaoglu, MD2; 1Istanbul Spine Center, Istanbul, Turkey; 2Istanbul, Turkey; 3Istanbul University Medical Faculty, Orthopedic and Traumatology Department, Istanbul, Turkey; 4Acibadem Maslak Hospital Spine Center, Istanbul, Turkey BACKGROUND CONTEXT: Shoulder asymmetry has been reported to be a frequent (39%) problem after fusion of the main thoracic (MT) curve in patients with nonstructural proximal thoracic (PT) curves (Lenke type1 and 3). PURPOSE: The purpose of this study was to analyze factors related to shoulder asymmetry and efficiency of traction X-ray imaging under general anesthesia (TrUGA) in predicting postop shoulder asymmetry. STUDY DESIGN/SETTING: Retrospective and clinical study. PATIENT SAMPLE: 137 patients. OUTCOME MEASURES: Statistical analyses were conducted by SPSS 15.0 (SPSS Inc., Chicago, IL, USA) METHODS: 137 (128F, 9M) consecutive patients (mean age 14.2 (1117)) with Lenke Type 1 and Lenke Type 3 curves and preop right shoulder elevation with (-) T1 tilt were included in this study. Radiographic analysis included preop, postop and follow/up (f/up) AP standing, supine bending and TrUGA. Magnitudes of curves, T1 tilt, clavicle angle, shoulder height, first rib angle and second rib angle were the measured as shoulder asymmetry parameters. Left or right shoulder elevation O 1cm is accepted as shoulder imbalance. SRS-22r and shoulder balance questionnaires were also analyzed in f/up. RESULTS: Mean age was 13.96 (11-17) years and avg follow/up (f/up) was 5.21 years (2-12). 107 patients had UIV at T2, 17 patients had UIV at T3 and 13 had UIV at T4. Average correction rates were 69.12% for PT curve, 82.4% for MT curve and 73.5% for TL/L curve. Postoperatively 101 patients (73%) had balanced shoulders. 17 patients (12.4%) had left shoulder elevation and 20 patients (14.6 %) right shoulder elevation postopreatively. Incidence of left shoulder elevation was 8.4% (9 pts) for UIV at T2, 29.4% (5pts) for UIV at T3 and 23.1% (3pts) UIV at T4. Higher % MT correction was correlated with left shoulder elevation (P50,043). Shoulder height, clavicle angle, T1 tilt, first rib angle and second rib angle were correlated in TrUGA and f/up (p!0,005). Preoperatively, 83% pts and at final f/up 7.8% patients thought they had shoulder asymmetry. Avg SRS-22r score was 4.32 (2,96-5) and was similar in patients who had shoulder asymmetry (4,36) vs no asymmetry (4,29). CONCLUSIONS: Risk factors for shoulder asymmetry in patients with nonstructural PT curves are a higher correction percentage of MT and extension of instrumentation up to T3 at PT curve. Extension of fusion up to T2 did not always prevent shoulder asymmetry in patients with nonstructural PT curves. Shoulder asymmetry parameters in TrUGA is helpful in predicting postop shoulder asymmetry. HRQL scores were similar in patients with shoulder asymmetry vs no shoulder asymmetry. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. http://dx.doi.org/10.1016/j.spinee.2014.08.386
http://dx.doi.org/10.1016/j.spinee.2014.08.387
P134. ACADIAÒ Facet Replacement System IDE Study: Preliminary Outcomes at Two- and Four-Years Postoperative Jacqueline Myer1, Jim A. Youssef, MD2, Kevin A. Rahn, MD3, Morgan P. Lorio, MD, FACS4, David J. McKee1; 1Globus Medical Inc., Audubon, PA, US; 2Durango Orthopedic Associates, Durango, CO, US; 3Ft. Wayne Orthopaedics, Fort Wayne, IN, US; 4NeuroSpine Solutions, Bristol, TN, US BACKGROUND CONTEXT: An Investigational Device Exemption (IDE) study is underway to evaluate the safety and efficacy of the ACADIAÒ Facet Replacement System for treatment of lumbar spinal stenosis.
Refer to onsite Annual Meeting presentations and postmeeting proceedings for possible referenced figures and tables. Authors are responsible for accurately reporting disclosures and FDA device/drug status at time of abstract submission.
Proceedings of the NASS 29th Annual Meeting / The Spine Journal 14 (2014) 1S–183S
had low to strong correlation. Disease specific PROs (Back Pain and ODI) have stronger correlations than general health and quality of life measures (SF-12 PCS and MCS). The responsiveness of questionnaires also varies with the method of data collection. Large scale studies need to be carried out to determine which method of data collection is more effective. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
P133. The Incidence of Symptomatic Adjacent Segment Disease Requiring Treatment: Cervical Arthroplasty versus ACDF Jacqueline Myer1, William Beutler, MD, FACS2, Jeffrey R. McConnell, MD3, James G. Lindley, Jr., MD4; 1Globus Medical Inc., Audubon, PA, US; 2 Pennsylvania Spine Institute, Harrisburg, PA, US; 3OAA Orthopaedic Specialists, Allentown, PA, US; 4Neurological Institute of Savannah and Center for Spine, Savannah, GA, US
http://dx.doi.org/10.1016/j.spinee.2014.08.385
BACKGROUND CONTEXT: The rate of subsequent adjacent level surgery for patients treated with SECUREÒ-C versus that of anterior cervical discectomy and fusion (ACDF) in the SECUREÒ-C IDE study was compared at long-term follow-up. STUDY DESIGN/SETTING: A prospective, randomized pivotal IDE study of the SECUREÒ-C Cervical Artificial Disc was conducted at 18 sites in the United States. PATIENT SAMPLE: Three hundred eighty patients were enrolled and treated in the study. Data are presented on 291 patients who were randomized and treated in the study: 151 SECUREÒ-C and 140 ACDF patients. METHODS: Criteria for study participation included symptomatic cervical disc disease in one vertebral level between C3 and C7, defined by neck and/or arm pain, herniated nucleus pulposus, radiculopathy or myelopathy, and other conditions as specified in the study protocol. All study patients have a preoperative Neck Disability Index (NDI) score of at least 30 (as a percentage of a 50-point total), have completed at least 6 weeks of conservative therapy, and are between 18 and 60 years of age. Enrolled patients were randomized 1:1 to either the investigational SECUREÒ-C disc or control ACDF, with the exception of the first five patients treated at each site who were nonrandomized and received SECUREÒ-C. RESULTS: Of the SECUREÒ-C patients, four underwent additional surgery at adjacent levels and were treated as follows: two-level foraminotomy at an adjacent level and a level below the adjacent level at 11.9 months postop; two-level fusion at 16.9 months (index and adjacent level); cervical disc replacement at an adjacent level at 17.3 months; posterior decompression at the index and an adjacent level at 19.2 months. Sixteen of the ACDF patients were surgically treated at an adjacent level or multiple levels at various postoperative time periods. Between 7 weeks and 3 years postop: seven ACDF patients underwent an adjacent level fusion and one patient had two adjacent levels fused. Between 3 years and 6 years postop, five patients had one adjacent level fused, two patients had two additional levels fused (adjacent level and level above adjacent level) and one patient had an adjacent level treated with an artificial disc. Cumulatively, by 6 years post-op, the rate of adjacent level surgery for randomized patients was 2.6% for the SECUREÒ-C group compared to 11.4% for ACDF. CONCLUSIONS: The rate of surgical treatment for adjacent segment disease was substantially lower in the randomized SECUREÒ-C group compared to the ACDF group. These results suggest that treatment of symptomatic cervical disc disease with motion preservation devices such as SECUREÒ-C may help reduce the risk of developing symptomatic adjacent segment disease that requires surgical treatment. FDA DEVICE/DRUG STATUS: SECURE-C Cervical Artificial Disc (Approved for this indication).
P132. Which Factors Predict Shoulder Asymmetry in Patients with Lenke Type 1 and 3 Curves following Pedicle Screw Instrumentation? Meric Enercan, MD1, Sinan Kahraman, MD1, Tunay Sanli, MA1, Bahadir Gokcen, MD1, Cagatay Ozturk, MD2, Ufuk Talu, MD3, Ahmet Alanay, MD4, Azmi Hamzaoglu, MD2; 1Istanbul Spine Center, Istanbul, Turkey; 2Istanbul, Turkey; 3Istanbul University Medical Faculty, Orthopedic and Traumatology Department, Istanbul, Turkey; 4Acibadem Maslak Hospital Spine Center, Istanbul, Turkey BACKGROUND CONTEXT: Shoulder asymmetry has been reported to be a frequent (39%) problem after fusion of the main thoracic (MT) curve in patients with nonstructural proximal thoracic (PT) curves (Lenke type1 and 3). PURPOSE: The purpose of this study was to analyze factors related to shoulder asymmetry and efficiency of traction X-ray imaging under general anesthesia (TrUGA) in predicting postop shoulder asymmetry. STUDY DESIGN/SETTING: Retrospective and clinical study. PATIENT SAMPLE: 137 patients. OUTCOME MEASURES: Statistical analyses were conducted by SPSS 15.0 (SPSS Inc., Chicago, IL, USA) METHODS: 137 (128F, 9M) consecutive patients (mean age 14.2 (1117)) with Lenke Type 1 and Lenke Type 3 curves and preop right shoulder elevation with (-) T1 tilt were included in this study. Radiographic analysis included preop, postop and follow/up (f/up) AP standing, supine bending and TrUGA. Magnitudes of curves, T1 tilt, clavicle angle, shoulder height, first rib angle and second rib angle were the measured as shoulder asymmetry parameters. Left or right shoulder elevation O 1cm is accepted as shoulder imbalance. SRS-22r and shoulder balance questionnaires were also analyzed in f/up. RESULTS: Mean age was 13.96 (11-17) years and avg follow/up (f/up) was 5.21 years (2-12). 107 patients had UIV at T2, 17 patients had UIV at T3 and 13 had UIV at T4. Average correction rates were 69.12% for PT curve, 82.4% for MT curve and 73.5% for TL/L curve. Postoperatively 101 patients (73%) had balanced shoulders. 17 patients (12.4%) had left shoulder elevation and 20 patients (14.6 %) right shoulder elevation postopreatively. Incidence of left shoulder elevation was 8.4% (9 pts) for UIV at T2, 29.4% (5pts) for UIV at T3 and 23.1% (3pts) UIV at T4. Higher % MT correction was correlated with left shoulder elevation (P50,043). Shoulder height, clavicle angle, T1 tilt, first rib angle and second rib angle were correlated in TrUGA and f/up (p!0,005). Preoperatively, 83% pts and at final f/up 7.8% patients thought they had shoulder asymmetry. Avg SRS-22r score was 4.32 (2,96-5) and was similar in patients who had shoulder asymmetry (4,36) vs no asymmetry (4,29). CONCLUSIONS: Risk factors for shoulder asymmetry in patients with nonstructural PT curves are a higher correction percentage of MT and extension of instrumentation up to T3 at PT curve. Extension of fusion up to T2 did not always prevent shoulder asymmetry in patients with nonstructural PT curves. Shoulder asymmetry parameters in TrUGA is helpful in predicting postop shoulder asymmetry. HRQL scores were similar in patients with shoulder asymmetry vs no shoulder asymmetry. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. http://dx.doi.org/10.1016/j.spinee.2014.08.386
http://dx.doi.org/10.1016/j.spinee.2014.08.387
P134. ACADIAÒ Facet Replacement System IDE Study: Preliminary Outcomes at Two- and Four-Years Postoperative Jacqueline Myer1, Jim A. Youssef, MD2, Kevin A. Rahn, MD3, Morgan P. Lorio, MD, FACS4, David J. McKee1; 1Globus Medical Inc., Audubon, PA, US; 2Durango Orthopedic Associates, Durango, CO, US; 3Ft. Wayne Orthopaedics, Fort Wayne, IN, US; 4NeuroSpine Solutions, Bristol, TN, US BACKGROUND CONTEXT: An Investigational Device Exemption (IDE) study is underway to evaluate the safety and efficacy of the ACADIAÒ Facet Replacement System for treatment of lumbar spinal stenosis.
Refer to onsite Annual Meeting presentations and postmeeting proceedings for possible referenced figures and tables. Authors are responsible for accurately reporting disclosures and FDA device/drug status at time of abstract submission.