The Effect of Combined Surgery in Management of Congenital Pseudarthrosis of Tibia
NCT ID: NCT02640040
Last Updated: 2020-10-22
Study Results
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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RECRUITING
NA
100 participants
INTERVENTIONAL
2015-08-31
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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combined surgery
combined surgery for enrolled patients with CPT(Congenital Pseudarthrosis of Tibia): sleeve resection of the pathological soft tissues, intramedullary rod fixation, packaged lilac bone autograft,and llizarov external fixation device installation.
llizarov external fixation device
llizarov external fixation device was applied to fix the tibia.
intramedullary rod fixation
retrograde intramedullary rod was applied to stabilize the tibia.
surgery
combined surgery for enrolled patients with CPT: sleeve resection of the pathological soft tissues, retrograde intramedullary rodding, packaged lilac bone autograft,and llizarov external fixation device installation.
Interventions
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llizarov external fixation device
llizarov external fixation device was applied to fix the tibia.
intramedullary rod fixation
retrograde intramedullary rod was applied to stabilize the tibia.
surgery
combined surgery for enrolled patients with CPT: sleeve resection of the pathological soft tissues, retrograde intramedullary rodding, packaged lilac bone autograft,and llizarov external fixation device installation.
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
* 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.
* Parents refused further treatment.
2 Years
18 Years
ALL
No
Sponsors
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Guangzhou Women and Children's Medical Center
OTHER
Shenzhen Children's Hospital
OTHER_GOV
Tongji Hospital
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Wuhan Women and Children's Medical Center
OTHER
Foshan Hospital of Traditional Chinese Medicine
OTHER
Beijing Children's Hospital
OTHER
Dalian Children's Hospital
OTHER
Children's Hospital of Chongqing Medical University
OTHER
Kunming Children's Hospital
OTHER
Hunan Children's Hospital
OTHER_GOV
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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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.
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.
Johnston CE 2nd. Congenital pseudarthrosis of the tibia: results of technical variations in the charnley-williams procedure. J Bone Joint Surg Am. 2002 Oct;84(10):1799-810.
Malhotra D, Puri R, Owen R. Valgus deformity of the ankle in children with spina bifida aperta. J Bone Joint Surg Br. 1984 May;66(3):381-5. doi: 10.1302/0301-620X.66B3.6373777.
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.
Zhu GH, Mei HB, He RG, Liu YX, Liu K, Tang J, Wu JY. Combination of intramedullary rod, wrapping bone grafting and Ilizarov's fixator for the treatment of Crawford type IV congenital pseudarthrosis of the tibia: mid-term follow up of 56 cases. BMC Musculoskelet Disord. 2016 Oct 22;17(1):443. doi: 10.1186/s12891-016-1295-1.
Other Identifiers
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HN02
Identifier Type: -
Identifier Source: org_study_id
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