Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03330158
Other study ID # RC31/15/7851
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 5, 2019
Est. completion date April 2025

Study information

Verified date March 2023
Source University Hospital, Toulouse
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this biomedical research is to evaluate the feasibility of the treatment with the new spinal distraction device ASTS in patients aged 4 to 10 years with severe early onset scoliosis. The hypothesis of this project is that the new fully implantable motorized spinal distraction device may provide a correction of scoliosis and progressive elongation ensuring patient comfort and minimizing complications. The ASTS (for Active Scoliosis Treatment System) growing rod is a new fully implantable motorized spinal distraction device which can ensure a correction of scoliosis and progressive elongation ensuring patient comfort and minimizing complications.


Description:

Despite a better understanding and technical progress, the evolutionary early scoliosis remains a therapeutic challenge. The definition includes idiopathic scoliosis beginning before the age of 3 years, congenital scoliosis, neuromuscular and syndromic. Spinal deformity is often progressive and may compromise cardiorespiratory function. The goal of treatment is to prevent further avoiding spinal fusion in a subject in growth. Surgery is indicated in case of failure or cons-indication of conservative treatment (corset or plaster). The principle is to position the posterior rods subcutaneous or in muscle attached to two ends of the deformation. Intraoperative distraction allows correction of the deformity. A new distraction is performed every 6 months until skeletal maturity. Considerable complication rates are reported (58%), mainly implant infections and disassembly, because of the need for multiple reoperations. Motorized implants can potentially avoid repeated interventions limiting complications. Thus, the central hypothesis of this project is a new fully implantable motorized spinal distraction device may provide a correction of scoliosis and progressive elongation ensuring patient comfort and minimizing complications.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 5
Est. completion date April 2025
Est. primary completion date February 2025
Accepts healthy volunteers No
Gender All
Age group 4 Years to 10 Years
Eligibility Inclusion Criteria: - Patient 4 to 10 years - Patient weight between 15kg at 50kg - Introducing severe scoliosis (Cobb angle> 40 °) with early onset - Failed or cons-indication of conservative treatment (cast or brace) - Agreement of parents or legal guardian (written agreement) and the patient (at least an oral agreement). Exclusion Criteria: - Contraindication to surgery - Age less than 4 years or above 10 years - Weight less 15kg and above 50 kg

Study Design


Related Conditions & MeSH terms


Intervention

Device:
ASTS
Implantation of a motorized spinal distraction rod

Locations

Country Name City State
France CHU de Toulouse Toulouse

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (12)

Akbarnia BA, Marks DS, Boachie-Adjei O, Thompson AG, Asher MA. Dual growing rod technique for the treatment of progressive early-onset scoliosis: a multicenter study. Spine (Phila Pa 1976). 2005 Sep 1;30(17 Suppl):S46-57. doi: 10.1097/01.brs.0000175190.08134.73. — View Citation

Baumgart R. The reverse planning method for lengthening of the lower limb using a straight intramedullary nail with or without deformity correction. A new method. Oper Orthop Traumatol. 2009 Jun;21(2):221-33. doi: 10.1007/s00064-009-1709-4. — View Citation

Bess S, Akbarnia BA, Thompson GH, Sponseller PD, Shah SA, El Sebaie H, Boachie-Adjei O, Karlin LI, Canale S, Poe-Kochert C, Skaggs DL. Complications of growing-rod treatment for early-onset scoliosis: analysis of one hundred and forty patients. J Bone Joint Surg Am. 2010 Nov 3;92(15):2533-43. doi: 10.2106/JBJS.I.01471. Epub 2010 Oct 1. — View Citation

den Uil CA, Bezemer R, Miranda DR, Ince C, Lagrand WK, Hartman M, Bogers AJ, Spronk PE, Simoons ML. Intra-operative assessment of human pulmonary alveoli in vivo using Sidestream Dark Field imaging: a feasibility study. Med Sci Monit. 2009 Oct;15(10):MT137-141. — View Citation

Flynn JM, Emans JB, Smith JT, Betz RR, Deeney VF, Patel NM, Campbell RM. VEPTR to treat nonsyndromic congenital scoliosis: a multicenter, mid-term follow-up study. J Pediatr Orthop. 2013 Oct-Nov;33(7):679-84. doi: 10.1097/BPO.0b013e31829d55a2. — View Citation

Kanter KR, Haggerty CM, Restrepo M, de Zelicourt DA, Rossignac J, Parks WJ, Yoganathan AP. Preliminary clinical experience with a bifurcated Y-graft Fontan procedure--a feasibility study. J Thorac Cardiovasc Surg. 2012 Aug;144(2):383-9. doi: 10.1016/j.jtcvs.2012.05.015. Epub 2012 Jun 13. — View Citation

Kerimaa P, Ojala R, Sinikumpu JJ, Hyvonen P, Korhonen J, Markkanen P, Tervonen O, Sequeiros RB. MRI-guided percutaneous retrograde drilling of osteochondritis dissecans of the talus: a feasibility study. Eur Radiol. 2014 Jul;24(7):1572-6. doi: 10.1007/s00330-014-3161-6. Epub 2014 Apr 17. — View Citation

Krieg AH, Speth BM, Foster BK. Leg lengthening with a motorized nail in adolescents : an alternative to external fixators? Clin Orthop Relat Res. 2008 Jan;466(1):189-97. doi: 10.1007/s11999-007-0040-3. Epub 2008 Jan 3. — View Citation

Lucas G, Bollini G, Jouve JL, de Gauzy JS, Accadbled F, Lascombes P, Journeau P, Karger C, Mallet JF, Neagoe P, Cottalorda J, De Billy B, Langlais J, Herbaux B, Fron D, Violas P. Complications in pediatric spine surgery using the vertical expandable prosthetic titanium rib: the French experience. Spine (Phila Pa 1976). 2013 Dec 1;38(25):E1589-99. doi: 10.1097/BRS.0000000000000014. — View Citation

Noordeen HM, Shah SA, Elsebaie HB, Garrido E, Farooq N, Al-Mukhtar M. In vivo distraction force and length measurements of growing rods: which factors influence the ability to lengthen? Spine (Phila Pa 1976). 2011 Dec 15;36(26):2299-303. doi: 10.1097/BRS.0b013e31821b8e16. Erratum In: Spine (Phila Pa 1976). 2012 Mar 1;37(5):432. Al Mukhtar, Mohannad [corrected to Al-Mukhtar, Mohannad]. — View Citation

Varni JW, Burwinkle TM, Seid M, Skarr D. The PedsQL 4.0 as a pediatric population health measure: feasibility, reliability, and validity. Ambul Pediatr. 2003 Nov-Dec;3(6):329-41. doi: 10.1367/1539-4409(2003)0032.0.co;2. — View Citation

Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006. — View Citation

* Note: There are 12 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Ability to Implant the device The surgeon will have to say if the implantation of the device has been done or not Day 0: the day of the implantation
Primary Change of the position of the implant 1 year after the implantation of the device, radiographs will be realised to ensure that the implant is still well positioning 1 years after the implantation
Primary Change of the position of the implant 2 years after the implantation of the device, radiographs will be realised to ensure that the implant is still weel positioning 2 years after the implantation
Primary Change of the position of the implant 3 years after the implantation of the device, radiographs will be realised to ensure that the implant is still weel positioning 3 years after the implantation
Primary Change of the implant's length The elongation of the implant will be measured in mm on the digital radiography 3 months, 6 months, 9 months, 1 year, 2 years and 3 years after the implantation
Secondary Post-surgical pain Self-assessment of pain using a visual analog scale 3 months, after the implantation
Secondary Post-surgical pain Self-assessment of pain using a visual analog scale months after the implantation
Secondary Post-surgical pain Self-assessment of pain using a visual analog scale 9 months after the implantation
Secondary Post-surgical pain Self-assessment of pain using a visual analog scale 1 year after the implantation
Secondary Survey to evaluate the quality of life Assess quality of life in the questionnaire PedsQL Day 0
Secondary Survey to evaluate the quality of life Assess quality of life in the questionnaire PedsQL 6 months after the implantation
Secondary Survey to evaluate the quality of life Assess quality of life in the questionnaire PedsQL 1 year after the implantation
Secondary to ease for the surgeon to implant the device, Number of participant with ease for the surgeon to implant the device, Day 0
Secondary wound closure without tension, Number of participant with closure of the wound without tension, Day 0
Secondary good positioning of the radiographic implant. Number participant with good positioning of the radiographic implant. Day 0
Secondary Number of medical visits Measure of the number of medical visit in the year after implant 1 year
Secondary Determine the number of iterative extensions made during follow-up Number of iterative extensions of 1 year. 1 year
Secondary correction of deformation immediately after the operation, Number of participant with correction of deformation immediately after the operation, 3 months, 6 months, 9 month and 1 year
Secondary correction of deformation immediately after the operation, Number of participant with correction of deformation immediately after the operation, 3 months after implantation
Secondary Loss correction at 1 year Loss correction at 1 year 6 months after implantation
Secondary Loss correction at 1 year Loss correction at 1 year 9 month after implantation
Secondary Loss correction at 1 year Loss correction at 1 year 1 year after implantation
Secondary Increase the distance T1-S1 at 1 year Increase the distance T1-S1 at 1 year (in mm) 1 year
Secondary Effective Elongation measured on radiographs of specification of the device (in mm) Effective Elongation measured on radiographs of specification of the device (in mm) 3 months after implantation
Secondary Effective Elongation measured on radiographs of specification of the device Effective Elongation measured on radiographs of specification of the device (in mm) 6 months after implantation
Secondary Effective Elongation measured on radiographs of specification of the device Effective Elongation measured on radiographs of specification of the device (in mm) 9 month after implantation
Secondary Effective Elongation measured on radiographs of specification of the device Effective Elongation measured on radiographs of specification of the device (in mm) 1 year after implantation
Secondary Nature of complications describe the nature of complication 1 years
Secondary Nature of complications describe the nature of complication 2 years
Secondary Nature of complications describe the nature of complication 3 years
Secondary Nature of complications describe the nature of complication 5 years
See also
  Status Clinical Trial Phase
Recruiting NCT04848376 - Post-Market Clinical Follow-up Study of A-SPINE's Products
Recruiting NCT05944393 - Erector Spine Plane (ESP) Block for Analgesia in Pediatric Scoliosis Surgery N/A
Recruiting NCT05888038 - Virtual Reality's Effect on Decreasing Pain and Subsequent Opioid Use in Pediatric Patients in the Post-Operative Period Following Scoliosis Repair N/A
Completed NCT02531945 - Evaluation of the Surface Topography for Monitoring Scoliosis Patients Aged 10-13 Years N/A
Completed NCT02413788 - Impact of Aerobic Training and Combined in Inflammatory Markers in Patients With Adolescent Idiopathic Scoliosis N/A
Completed NCT02890654 - Scoliosis and Quality of Life of Adolescents
Completed NCT02558985 - Pulmonary Compliance Changes During Manipulation of Early Onset Scoliosis and Cast Application
Terminated NCT02134704 - MOUVSCO: Kinematic Analysis of the Trunk in Patients With Moderate Scoliosis N/A
Completed NCT02609009 - Back Pain and Spinal Manipulation in Adolescent Scoliosis N/A
Completed NCT02285621 - Validation of a New Generation of Optimized Orthoses for Personalized Treatment of Adolescent Idiopathic Scoliosis N/A
Withdrawn NCT00768313 - Phase IV Comparing Rods of Yield Strengths to Correct Adolescent Idiopathic Scoliosis. Phase 4
Completed NCT00155545 - Influence of Leg Length Discrepancy on the Spinal Shape and Biomechanics in Functional and Idiopathic Scoliosis Patients Phase 1
Completed NCT00154505 - Effects of Lateral Trunk Support on Spinal Alignment in Spinal Cord Injured Persons Phase 1
Completed NCT00320619 - Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following Spine Surgery N/A
Completed NCT00273598 - Comparing Two Instrumentation Systems for the Treatment of Adolescent Scoliosis Phase 2
Completed NCT03135665 - Using Radiation-free Ultrasound for Screening Scoliosis Among School Children in Hong Kong to Reduce Unnecessary X-ray Exposure N/A
Completed NCT06428864 - Effect of the Use of a 3D Scanner Application on a Smartphone to Mold Garchois Orthotic Device in Neuromuscular Diseases Patients With Scoliosis
Recruiting NCT04423146 - Anesthesiologic Management Effect on Perioperative Outcome in Scoliosis Surgery
Completed NCT03814239 - Blood and Fluid Management During Scoliosis Surgery
Withdrawn NCT02058238 - ADDRESS - Adult Deformity Robotic vs. Freehand Surgery to Correct Spinal Deformity