This trial reports the long-term clinical outcomes of skeletally immature patients treated with AVBT, specifically in regards to effect on three-dimensional spine growth, maintenance of major Cobb angle, and complications associated with both the procedure and the device.
- Idiopathic Scoliosis
3 Primary · 0 Secondary · Reporting Duration: 5 years
0 Treatment Group
106 Total Participants · 0 Treatment Group
Primary Treatment: Treatment · No Placebo Group · N/A
Who is running the clinical trial?
Age < 65 · All Participants · 6 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
- Coghlan, Ryan F., Jon A. Oberdorf, Susan Sienko, Michael D. Aiona, Bruce A. Boston, Kara J. Connelly, Chelsea Bahney, et al.. 2017. “A Degradation Fragment of Type X Collagen Is a Real-time Marker for Bone Growth Velocity”. Science Translational Medicine. American Association for the Advancement of Science (AAAS). doi:10.1126/scitranslmed.aan4669.
- Trobisch, Per, Olaf Suess, and Frank Schwab. 2010. “Idiopathic Scoliosis”. Deutsches Ärzteblatt International. Deutscher Arzte-Verlag GmbH. doi:10.3238/arztebl.2010.0875.
- Karol, Lori A., Charles Johnston, Kiril Mladenov, Peter Schochet, Patricia Walters, and Richard H. Browne. 2008. “Pulmonary Function Following Early Thoracic Fusion in Non-neuromuscular Scoliosis”. The Journal of Bone & Joint Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.2106/jbjs.g.00184.
- Samdani, Amer F., Robert J. Ames, Jeff S. Kimball, Joshua M. Pahys, Harsh Grewal, Glenn J. Pelletier, and Randal R. Betz. 2014. “Anterior Vertebral Body Tethering for Immature Adolescent Idiopathic Scoliosis: One-year Results on the First 32 Patients”. European Spine Journal. Springer Science and Business Media LLC. doi:10.1007/s00586-014-3706-z.
- Crawford, Charles H, III, and Lawrence G Lenke. 2010. “Growth Modulation by Means of Anterior Tethering Resulting in Progressive Correction of Juvenile Idiopathic Scoliosis”. The Journal of Bone and Joint Surgery-american Volume. Ovid Technologies (Wolters Kluwer Health). doi:10.2106/jbjs.h.01728.
- Samdani, Amer F., Robert J. Ames, Jeff S. Kimball, Joshua M. Pahys, Harsh Grewal, Glenn J. Pelletier, and Randal R. Betz. 2014. “Anterior Vertebral Body Tethering for Idiopathic Scoliosis”. Spine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/brs.0000000000000472.
- Spurway, Alan J., Jennifer K. Hurry, Luke Gauthier, Ben Orlik, Chukwudi K. Chukwunyerenwa, Waleed E. Kishta, and Ron El-Hawary. 2017. “Three-dimensional True Spine Length: A Novel Technique for Assessing the Outcomes of Scoliosis Surgery”. Journal of Pediatric Orthopaedics. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/bpo.0000000000001031.
- Sarwahi, Vishal, Stephen Wendolowski, Rachel Gecelter, Kathleen Maguire, Melanie Gambassi, Dana Orlando, Yungtai Lo, and Terry Amaral. 2018. “When Do Patients Return to Physical Activities and Athletics After Scoliosis Surgery?”. Spine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/brs.0000000000002284.
- Miyanji, Firoz, Jeff Pawelek, Luigi A. Nasto, Paul Rushton, Andrea Simmonds, and Stefan Parent. 2020. “Safety and Efficacy of Anterior Vertebral Body Tethering in the Treatment of Idiopathic Scoliosis”. The Bone & Joint Journal. British Editorial Society of Bone & Joint Surgery. doi:10.1302/0301-620x.102b12.bjj-2020-0426.r1.
- Coghlan RF, Oberdorf JA, Sienko S, Aiona MD, Boston BA, Connelly KJ, Bahney C, LaRouche J, Almubarak SM, Coleman DT, Girkontaite I, von der Mark K, Lunstrum GP, Horton WA. A degradation fragment of type X collagen is a real-time marker for bone growth velocity. Sci Transl Med. 2017 Dec 6;9(419):eaan4669. doi: 10.1126/scitranslmed.aan4669.
- Crawford CH 3rd, Lenke LG. Growth modulation by means of anterior tethering resulting in progressive correction of juvenile idiopathic scoliosis: a case report. J Bone Joint Surg Am. 2010 Jan;92(1):202-9. doi: 10.2106/JBJS.H.01728. No abstract available.
- Trobisch P, Suess O, Schwab F. Idiopathic scoliosis. Dtsch Arztebl Int. 2010 Dec;107(49):875-83; quiz 884. doi: 10.3238/arztebl.2010.0875. Epub 2010 Dec 10.
- 2021. "A Prospective Analysis of Long-Term Clinical Outcomes and 3D Spine Growth in Anterior Vertebral Body Tethering". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04914507.
Frequently Asked Questions
Are there any slots available to join this clinical experiment?
"Affirmative, the clinicaltrials.gov database verifies that this medical experiment is in search of participants who meet its criteria. The trial was initially listed on September 9th 2021 and revised most recently on July 5th 2022; 106 patients are needed to be recruited from nine sites across the country." - Anonymous Online Contributor
What is the total quantity of health care facilities that are currently administrating this experiment?
"Nine locations are currently looking for trial participants, including Shriners Children's Portland in Portland, Children's National Hospital in Washington, and Gillette Children's Specialty Healthcare in Saint Paul. Other facilities exist as well." - Anonymous Online Contributor
How many individuals are partaking in this research endeavor?
"The medical study necessitates recruiting 106 suitable participants across two sites: Shriners Children's Portland in Portland, Oregon and Children's National Hospital in Washington D.C." - Anonymous Online Contributor