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| Name | Class |
|---|---|
| Alphatec Spine, Inc. | INDUSTRY |
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Surgical intervention may provide pain relief and improvement in function but one area of significant clinical interest is the restoration/improvement in gait and functional balance. Based on the investigators knowledge, there is limited literature on biomechanics and neuromuscular control of the lower extremities and spine as assessed by objective gait analysis and balance strategies in adult degenerative scoliosis patients, pre and post surgical intervention. The purpose of this study is to determine the impact of spinal deformity on the biomechanics and neuromuscular control of the lower and upper extremities, and also investigate the impact of surgery on these functions as evaluated by gait and balance analyses using dynamic EMG, video motion capture and force plate analysis and also to compare these patients with healthy controls to better evaluate the extent of limitations before and after surgery.
Degenerative adult scoliosis results from age related changes leading to segmental instability, deformity and stenosis. Although the etiology is unclear, degenerative adult scoliosis is associated with progressive and asymmetric degeneration of the disc and facet joints, which typically lead to stenosis. By virtue of the narrowed spinal canal associated with the degeneration these patients frequently develop back pain, as well as leg pain, weakness, and numbness. With an aging population in the USA and an increased attention to quality of life versus cost issues in the current healthcare environment, degenerative adult scoliosis has become a considerable healthcare concern.
Patients with scoliosis demonstrate an altered gait pattern. Such differences include decreased step length and reduced range of motion in the upper and lower extremities, asymmetry of trunk rotation and ground reaction force in three-dimensions. Mahaudens et al. found a decrease in the muscular mechanical work associated with an increase of energy cost and a decrease in the muscular efficiency in a scoliosis population compared to healthy controls. Furthermore, scoliosis patients exert 30% more physical effort than healthy subjects to ensure habitual locomotion, and this additional effort requires a reciprocal increase of oxygen consumption. This altered gait pattern demonstrated by subjects with scoliosis may be due to changes in global postural control strategies caused by spinal deformity.
Previous research showed that scoliosis patients do not have impaired postural balance when compared to healthy controls, while several others did find an effect of scoliosis on postural balance. This discrepancy in findings may be due to differences in curve characteristics included and their effects on postural balance, curve types (single or double), number of different curve types, location of curves (thoracic and lumbar), and/or Cobb angles. Furthermore, Schimmel et al. found that postural balance one year after surgery did not improve as a result of the better spinal alignment, neither did the reduced range of trunk motion inherent to fusion negatively affect postural balance.
While medicinal interventions may assist with some of the associated co-morbid conditions, surgical interventions may be indicated for those patients with intractable and debilitating low back and leg pain. These surgeries have proven to be extremely successful in a majority of patients. The surgeries may involve decompression and instrumentation to stabilize the spine to achieve arthrodesis.
Surgical intervention may provide pain relief and improvement in function but one area of significant clinical interest is the restoration/improvement in gait and functional balance. Based on the investigators knowledge, there is limited literature on biomechanics and neuromuscular control of the lower extremities and spine as assessed by objective gait analysis and balance strategies in adult degenerative scoliosis patients, pre and post surgical intervention. The purpose of this study is to determine the impact of spinal deformity on the biomechanics and neuromuscular control of the lower and upper extremities, and also investigate the impact of surgery on these functions as evaluated by gait and balance analyses using dynamic Electromyograph (EMG), video motion capture and force plate analysis and also to compare these patients with healthy controls to better evaluate the extent of limitations before and after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical Group | Experimental | Gait and balance testing as well as self-reported outcome assessments to be administered before and after surgery |
|
| Control Group | Other | Gait and balance testing to be administered once in healthy subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical intervention | Procedure | Surgery to correct spinal deformity |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Kinematic Variables Change assessed with human motion capture system | 3-Dimensional Range of Motion (ROM) during the stance and swing phase. | Prior to surgery; 3 and 12 months after surgery |
| Kinetic Variables Change assessed with human motion capture system | Vertical Ground Reaction Forces (GRF) | Prior to surgery; 3 and 12 months after surgery |
| Electromyography Variables Change assessed with an Electromyograph | Bilateral peak magnitude during the stance phase | Prior to surgery; 3 and 12 months after surgery |
| Spatio-Temporal Variables Change assessed with human motion capture system | Walking Speed | Prior to surgery; 3 and 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Self-Reported Outcome Assessments Change | Visual Analog Scale (VAS) | Prior to surgery; 3 and 12 months after surgery |
| Patient Self-Reported Outcome Assessments Change | Scoliosis Research Society (SRS) -22 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ram Haddas, PhD | Contact | 972-943-2730 | rhaddas@texas.com |
| Name | Affiliation | Role |
|---|---|---|
| Ram Haddas, PhD | Texas Back Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Back Institute | Recruiting | Plano | Texas | 75093 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23024623 | Background | Kotwal S, Pumberger M, Hughes A, Girardi F. Degenerative scoliosis: a review. HSS J. 2011 Oct;7(3):257-64. doi: 10.1007/s11420-011-9204-5. Epub 2011 Jun 11. | |
| 24600296 | Background | Kotwicki T, Chowanska J, Kinel E, Czaprowski D, Tomaszewski M, Janusz P. Optimal management of idiopathic scoliosis in adolescence. Adolesc Health Med Ther. 2013 Jul 23;4:59-73. doi: 10.2147/AHMT.S32088. eCollection 2013. |
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| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| None (Asymptomatic group) |
| Other |
Gait and balance testing performed, no treatment in this asymptomatic group |
|
| Prior to surgery; 3 and 12 months after surgery |
| Patient Self-Reported Outcome Assessments Change | Neck Disability Index (NDI) | Prior to surgery; 3 and 12 months after surgery |
| Patient Self-Reported Outcome Assessments Change | Oswestry Disability Index (ODI) | Prior to surgery; 3 and 12 months after surgery |
| 17630141 | Background | Ploumis A, Transfledt EE, Denis F. Degenerative lumbar scoliosis associated with spinal stenosis. Spine J. 2007 Jul-Aug;7(4):428-36. doi: 10.1016/j.spinee.2006.07.015. Epub 2007 Feb 28. |
| 11547203 | Background | Engsberg JR, Bridwell KH, Reitenbach AK, Uhrich ML, Baldus C, Blanke K, Lenke LG. Preoperative gait comparisons between adults undergoing long spinal deformity fusion surgery (thoracic to L4, L5, or sacrum) and controls. Spine (Phila Pa 1976). 2001 Sep 15;26(18):2020-8. doi: 10.1097/00007632-200109150-00016. |
| 23732766 | Background | Yang JH, Suh SW, Sung PS, Park WH. Asymmetrical gait in adolescents with idiopathic scoliosis. Eur Spine J. 2013 Nov;22(11):2407-13. doi: 10.1007/s00586-013-2845-y. Epub 2013 Jun 4. |
| 19224255 | Background | Mahaudens P, Banse X, Mousny M, Detrembleur C. Gait in adolescent idiopathic scoliosis: kinematics and electromyographic analysis. Eur Spine J. 2009 Apr;18(4):512-21. doi: 10.1007/s00586-009-0899-7. Epub 2009 Feb 18. |
| Background | Arima H, Yamato Y, Hasegawa T, et al. Gait analysis after corrective surgery for adult spinal deformity - good sagittal balance with improved lumber lordosis is important. Scoliosis. 2015;10(Suppl 1):O76. |
| 15064994 | Background | Kramers-de Quervain IA, Muller R, Stacoff A, Grob D, Stussi E. Gait analysis in patients with idiopathic scoliosis. Eur Spine J. 2004 Aug;13(5):449-56. doi: 10.1007/s00586-003-0588-x. Epub 2004 Apr 3. |
| 9629931 | Background | Schizas CG, Kramers-de Quervain IA, Stussi E, Grob D. Gait asymmetries in patients with idiopathic scoliosis using vertical forces measurement only. Eur Spine J. 1998;7(2):95-8. doi: 10.1007/s005860050037. |
| 15221574 | Background | Chockalingam N, Dangerfield PH, Rahmatalla A, Ahmed el-N, Cochrane T. Assessment of ground reaction force during scoliotic gait. Eur Spine J. 2004 Dec;13(8):750-4. doi: 10.1007/s00586-004-0762-9. Epub 2004 Jun 22. |
| 8902968 | Background | Giakas G, Baltzopoulos V, Dangerfield PH, Dorgan JC, Dalmira S. Comparison of gait patterns between healthy and scoliotic patients using time and frequency domain analysis of ground reaction forces. Spine (Phila Pa 1976). 1996 Oct 1;21(19):2235-42. doi: 10.1097/00007632-199610010-00011. |
| 19390877 | Background | Mahaudens P, Detrembleur C, Mousny M, Banse X. Gait in adolescent idiopathic scoliosis: energy cost analysis. Eur Spine J. 2009 Aug;18(8):1160-8. doi: 10.1007/s00586-009-1002-0. Epub 2009 Apr 24. |
| 2520074 | Background | O'Beirne J, Goldberg C, Dowling FE, Fogarty EE. Equilibrial dysfunction in scoliosis--cause or effect? J Spinal Disord. 1989 Sep;2(3):184-9. |
| 20975488 | Background | Kuo FC, Wang NH, Hong CZ. Impact of visual and somatosensory deprivation on dynamic balance in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2010 Nov 1;35(23):2084-90. doi: 10.1097/BRS.0b013e3181cc8108. |
| 26519115 | Background | Karimi MT, Kavyani M, Kamali M. Balance and gait performance of scoliotic subjects: A review of the literature. J Back Musculoskelet Rehabil. 2016 Aug 10;29(3):403-15. doi: 10.3233/BMR-150641. |
| 19066989 | Background | Beaulieu M, Toulotte C, Gatto L, Rivard CH, Teasdale N, Simoneau M, Allard P. Postural imbalance in non-treated adolescent idiopathic scoliosis at different periods of progression. Eur Spine J. 2009 Jan;18(1):38-44. doi: 10.1007/s00586-008-0831-6. Epub 2008 Dec 6. |
| 26056528 | Background | Schimmel JJ, Groen BE, Weerdesteyn V, de Kleuver M. Adolescent idiopathic scoliosis and spinal fusion do not substantially impact on postural balance. Scoliosis. 2015 Jun 9;10:18. doi: 10.1186/s13013-015-0042-y. eCollection 2015. |
| 16778672 | Background | Guo X, Chau WW, Hui-Chan CW, Cheung CS, Tsang WW, Cheng JC. Balance control in adolescents with idiopathic scoliosis and disturbed somatosensory function. Spine (Phila Pa 1976). 2006 Jun 15;31(14):E437-40. doi: 10.1097/01.brs.0000222048.47010.bf. |
| 17052338 | Background | Simoneau M, Mercier P, Blouin J, Allard P, Teasdale N. Altered sensory-weighting mechanisms is observed in adolescents with idiopathic scoliosis. BMC Neurosci. 2006 Oct 19;7:68. doi: 10.1186/1471-2202-7-68. |
| 25210479 | Background | Sachs D, Capobianco R, Cher D, Holt T, Gundanna M, Graven T, Shamie AN, Cummings J Jr. One-year outcomes after minimally invasive sacroiliac joint fusion with a series of triangular implants: a multicenter, patient-level analysis. Med Devices (Auckl). 2014 Aug 28;7:299-304. doi: 10.2147/MDER.S56491. eCollection 2014. |
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| Background | Portney LG, Watkins MP. Foundation of clinical research: applications to practice. 3rd ed. Upper Saddle River, New Jersy: Julie Levin Alexander; 2009. |
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