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Assessment and Follow-up of Surgical Treatment of Hemivertebra in Children

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ClinicalTrials.gov Identifier: NCT03772119
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours

Brief Summary:
The treatment of child's vertebral malformations has evolved a lot including the realization of surgical vertebral resections. The surgical techniques used are multiple, require heavy surgery, one or more approaches and surgical time, transfusions, a neurological risk (up to 20% in some series, risk of non-consolidation, insufficient correction). These surgical techniques deserve an evaluation of the early complications and the skeletal maturity of these children (maintenance of the surgical correction, evolution of the associated curvatures).

Condition or disease Intervention/treatment
Hemivertebra Procedure: Surgical resection

Detailed Description:
The treatment of child's vertebral malformations has evolved a lot including the realization of surgical vertebral resections. The surgical techniques used are multiple, require heavy surgery, one or more approaches and surgical time, transfusions, a neurological risk (up to 20% in some series, risk of non-consolidation, insufficient correction). These surgical techniques deserve an evaluation of the early complications and the skeletal maturity of these children (maintenance of the surgical correction, evolution of the associated curvatures).

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 15 Years
Official Title: Assessment and Follow-up of Surgical Treatment of Hemivertebra in Children
Actual Study Start Date : February 4, 2019
Estimated Primary Completion Date : February 2039
Estimated Study Completion Date : February 2039

Group/Cohort Intervention/treatment
Surgical treatment of hemivertebra
cohort of children with a vertebral malformation treated by surgical resection
Procedure: Surgical resection
Surgical resection of hemivertebra




Primary Outcome Measures :
  1. Immediate effectiveness of surgery: Evolution of Cobb angle [ Time Frame: From baseline to 6 months after surgery ]
    Effectiveness of immediate correction : spinal deformities measured by the Cobb angle on radios face and profile

  2. Appearances of complications [ Time Frame: From baseline to 6 months after surgery ]
    Appearances of complications (neurological, vascular, non consolidation) at 6 months. These complications will be gathered from hospitalization reports.

  3. Late persistence of complications [ Time Frame: From 6 months after surgery to 15 years ]
    Persistent complications will be collected through clinical examination at follow-up visits.


Secondary Outcome Measures :
  1. Long-term effectiveness of surgery: Evolution of Cobb angle [ Time Frame: From 6 months after surgery to 15 years ]
    Maintaining local correction with growth: spinal deformities measured by the Cobb angle on radios face and profile



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Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
children from 3 to 10 years old with vertebral malformation requiring surgery for hemivertebra
Criteria

Inclusion Criteria:

  • Child from 3 to 10 years old
  • with a vertebral malformation requiring surgery for hemivertebras

Exclusion Criteria:

  • Child previously operated on the spine
  • Different procedure of a surgical resection of vertebral malformation
  • Absence of medical follow-up
  • Parents refusal concerning data storage

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772119


Contacts
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Contact: Thierry ODENT, MD-PhD 02 47 47 38 22 ext +33 T.ODENT@chu-tours.fr

Locations
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France
Pediatric Surgery Service, University Hospital, Bordeaux Not yet recruiting
Bordeaux, France, 33000
Contact: Yan LEFEVRE, MD-PhD         
Pediatric Surgery Service, University Hospital, Grenoble Not yet recruiting
Grenoble, France, 38043
Contact: Aurélien COURVOISIER, MD-PhD         
Pediatric Surgery Service, University Hospital, Lyon Not yet recruiting
Lyon, France, 69677
Contact: Thierry HAUMONT, MD-PhD         
Contact: Vincent CUNIN, MD         
Pediatric Surgery Service, University Hospital, Marseille Not yet recruiting
Marseille, France, 13005
Contact: Sébastien PESSENTI, MD-PhD         
Pediatric Surgery Service, University Hospital, Nantes Not yet recruiting
Nantes, France, 44093
Contact: Antoine DUHAMEL, MD-PhD         
Pediatric Surgery Service, University Hospital, Nice Recruiting
Nice, France, 06200
Contact: Federico SOLLA, MD         
Pediatric Surgery Service, University Hospital, Armand Trousseau Hospital, AP-HP Not yet recruiting
Paris, France, 75012
Contact: Raphael VIALLE, MD-PhD         
Pediatric Surgery Service, Robert-Debré Hospital, AP-HP Not yet recruiting
Paris, France, 75019
Contact: Brice ILHARREBORDE, MD-PhD         
Contact: Keyvan MAZDA, MD-PhD         
Pediatric Surgery Service, University Hospital, Necker Hospital, AP-HP Not yet recruiting
Paris, France, 75730
Contact: Lofti MILADI, MD         
Pediatric Surgery Service, University Hospital, Rennes Recruiting
Rennes, France, 35203
Contact: Philippe VIOLAS, MD-PhD         
Pediatric Surgery Service, University Hospital, Saint-Etienne Recruiting
Saint-Étienne, France, 42055
Contact: Elie HADDAD, MD         
Contact: Bruno DOHIN, MD-PhD         
Pediatric Surgery Service, University Hospital, Toulouse Recruiting
Toulouse, France, 31059
Contact: Franck ACCADBLED, MD-PhD         
Pediatric Surgery Service, University Hospital, Tours Not yet recruiting
Tours, France, 37044
Contact: Thierry ODent, MD-PhD         
Sponsors and Collaborators
University Hospital, Tours
Investigators
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Study Director: Thierry ODENT, MD-PhD University Hospttal, Tours
Additional Information:

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Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT03772119    
Other Study ID Numbers: RIPH3-RNI17/HEMIVERTEBRE SOFOP
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Tours:
Vertebral Malformation
Hemivertebra
Surgical resection
SOFOP