A Retrospective Study of Surgical Treatment of Congenital Pseudarthrosis of Tibia in China

NCT ID: NCT02896114

Last Updated: 2020-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2022-12-31

Brief Summary

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The study aims to evaluate the current methods of surgical treatment for Congenital Pseudarthrosis of tibia(CPT) in children and their results respectively.

Detailed Description

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The study aims to evaluate the current surgical treatment and its result for Congenital Pseudarthrosis of tibia (CPT)in children in China. A retrospective study will be conducted with around 150 patients at 11 centers in China. This study will use available registry data from a defined time period of Jan 2006-Dec 2014. The treatment method will be recorded. The bone union rate and the refracture rate were calculated to evaluate the final result of several surgical treatment.

Conditions

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Congenital Pseudarthrosis of Tibia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Exclusion Criteria

* 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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou Women and Children's Medical Center

OTHER

Sponsor Role collaborator

Shenzhen Children's Hospital

OTHER_GOV

Sponsor Role collaborator

Tongji Hospital

OTHER

Sponsor Role collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role collaborator

Wuhan Women and Children's Medical Center

OTHER

Sponsor Role collaborator

Foshan Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Beijing Children's Hospital

OTHER

Sponsor Role collaborator

Dalian Children's Hospital

OTHER

Sponsor Role collaborator

Children's Hospital of Chongqing Medical University

OTHER

Sponsor Role collaborator

Kunming Children's Hospital

OTHER

Sponsor Role collaborator

Hunan Children's Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xu Yao

Role: PRINCIPAL_INVESTIGATOR

Hunan Children's Hospital

Locations

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Hunan Children's Hospital

Changsha, Hunan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Haibo Mei

Role: CONTACT

008613975197731

Kewei Wang

Role: CONTACT

008673185600908

Facility Contacts

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Kewei Wang, M.D.

Role: primary

008673185600908

References

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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.

Reference Type BACKGROUND
PMID: 15718906 (View on PubMed)

Romanus 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.

Reference Type BACKGROUND
PMID: 10868357 (View on PubMed)

Mathieu 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.

Reference Type BACKGROUND
PMID: 19308541 (View on PubMed)

Other Identifiers

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HN03

Identifier Type: -

Identifier Source: org_study_id

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