Clinical Assessment of a Motorized Spinal Distraction Rod in the Severe to Early Scoliosis Child

NCT03330158 | Active Not Recruiting DMC

• 1 other identifier: RC31/15/7851
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Scoliosis

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (26)

• Post-surgical pain

  3 months, after the implantation

• Post-surgical pain

  months after the implantation

• Post-surgical pain

  9 months after the implantation

• Post-surgical pain

  1 year after the implantation

• Survey to evaluate the quality of life

  Day 0

Study Arms (1)

ASTS device

EXPERIMENTAL

Implantation of device ASTS (for ACTIVE TREATMENT SCOLIOSIS SYSTEM ) in children between 4 and 10

Device: ASTS

Interventions

ASTS DEVICE

Implantation of a motorized spinal distraction rod

ASTS device

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• Contraindication to surgery
• Age less than 4 years or above 10 years
• Weight less 15kg and above 50 kg

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU de Toulouse

Toulouse, 31000, France

Location

Related Publications (12)

• 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.

  PMID: 21494191 BACKGROUND

• 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.

  PMID: 11468499 BACKGROUND

• 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.

  PMID: 14616041 BACKGROUND

• 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.

  PMID: 16138066 BACKGROUND

• 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.

  PMID: 20889912 BACKGROUND

• 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.

  PMID: 24048087 BACKGROUND

• 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.

  PMID: 18196392 BACKGROUND

• 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.

  PMID: 19685230 BACKGROUND

• 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.

  PMID: 19789519 BACKGROUND

• 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.

  PMID: 22698555 BACKGROUND

• 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.

  PMID: 24740345 BACKGROUND

• 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.

  PMID: 23812154 BACKGROUND

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Franck Accadbled, MD PhD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: November 6, 2017
• Study Start: February 5, 2019
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)