A Retrospective Study of Surgical Treatment of Congenital Pseudarthrosis of Tibia in China
1 other identifier
observational
150
1 country
1
Brief Summary
The study aims to evaluate the current methods of surgical treatment for Congenital Pseudarthrosis of tibia(CPT) in children and their results respectively.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 6, 2016
CompletedFirst Posted
Study publicly available on registry
September 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedOctober 22, 2020
October 1, 2020
6.3 years
September 6, 2016
October 20, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
whether the tibial has obtained union
Ohnishi criterion: Degree of union was evaluated by the findings on radiographs and classified into three grades( Ohnishi criterion): union, delayed union, and nonunion. Radiographic union was defined as possessing continuity of bone density between the fragments without obvious radiolucent zone between them and possessing cortex-bridging fragments with sufficient thickness and radiodensity on both anteroposterior and lateral radiographs. Delayed union was defined as a process of healing that was slow but was progressing. Nonunion was defined by the healing process that had completely ceased.
9 months post-operation
Secondary Outcomes (2)
clinical outcome measurement(Johnston clinical evaluation criterion)
9 months post-operation，the last follow up
Refracture of tibia
Time Frame: 1,2,3,4,5,6,7,8,9 years post-operation,the last follow-up
Eligibility Criteria
patients with congenital pseudarthrosis of Tibia who were surgical treated to obtain bone union.
You may not qualify if:
- Patients are complicated with mental, neurological disorders (such as hypoxic-ischemic encephalopathy, epilepsy and dementia) or significant barriers to growth.
- Patients with pseudarthrosis of tibia caused by trauma, tumor,infection, etc
- Children are complicated with dysfunction of liver and kidney , blood disorders, immune deficiency disease and ECG abnormalities.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hunan Children's Hospitallead
- Guangzhou Women and Children's Medical Centercollaborator
- Shenzhen Children's Hospitalcollaborator
- Tongji Hospitalcollaborator
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technologycollaborator
- Wuhan Women and Children's Medical Centercollaborator
- Foshan Hospital of Traditional Chinese Medicinecollaborator
- Beijing Children's Hospitalcollaborator
- Dalian Children's Hospitalcollaborator
- Children's Hospital of Chongqing Medical Universitycollaborator
- Kunming Children's Hospitalcollaborator
Study Sites (1)
Hunan Children's Hospital
Changsha, Hunan, 410007, China
Related Publications (3)
Ohnishi I, Sato W, Matsuyama J, Yajima H, Haga N, Kamegaya M, Minami A, Sato M, Yoshino S, Oki T, Nakamura K. Treatment of congenital pseudarthrosis of the tibia: a multicenter study in Japan. J Pediatr Orthop. 2005 Mar-Apr;25(2):219-24. doi: 10.1097/01.bpo.0000151054.54732.0b.
PMID: 15718906BACKGROUNDRomanus B, Bollini G, Dungl P, Fixsen J, Grill F, Hefti F, Ippolito E, Tudisco C, Wientroub S. Free vascular fibular transfer in congenital pseudoarthrosis of the tibia: results of the EPOS multicenter study. European Paediatric Orthopaedic Society (EPOS). J Pediatr Orthop B. 2000 Apr;9(2):90-3. doi: 10.1097/01202412-200004000-00003.
PMID: 10868357BACKGROUNDMathieu L, Vialle R, Thevenin-Lemoine C, Mary P, Damsin JP. Association of Ilizarov's technique and intramedullary rodding in the treatment of congenital pseudarthrosis of the tibia. J Child Orthop. 2008 Dec;2(6):449-55. doi: 10.1007/s11832-008-0139-4. Epub 2008 Oct 28.
PMID: 19308541BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Xu Yao
Hunan Children's Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2016
First Posted
September 12, 2016
Study Start
September 1, 2016
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
October 22, 2020
Record last verified: 2020-10