The Effect of Combined Surgery in Management of Congenital Pseudarthrosis of Tibia
1 other identifier
interventional
100
1 country
1
Brief Summary
The study aims to evaluate the clinical result of Combined Surgery in Management of Congenital Pseudarthrosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2015
Longer than P75 for not_applicable
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
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 31, 2015
CompletedFirst Posted
Study publicly available on registry
December 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedOctober 22, 2020
October 1, 2020
10.3 years
August 31, 2015
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.
6 months post-operation
Secondary Outcomes (2)
clinical outcome measurement(Johnston clinical evaluation criterion)
3,6,9,12,18,24 months post-operation
Refracture of tibia
0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation
Other Outcomes (3)
Residual Deformity-proximal tibia angulation(range,0°-90°)
pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation
Residual Deformity-Limb length discrepancy
pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation
Residual Deformity-ankle valgus angulation(range,0°-90°)
pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation
Study Arms (1)
combined surgery
EXPERIMENTALcombined 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.
Interventions
llizarov external fixation device was applied to fix the tibia.
retrograde intramedullary rod was applied to stabilize the tibia.
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.
Eligibility Criteria
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.
- Parents refused further treatment.
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 (6)
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: 10868357BACKGROUNDJohnston 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.
PMID: 12377911BACKGROUNDMalhotra 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.
PMID: 6373777BACKGROUNDMathieu 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: 19308541BACKGROUNDZhu 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.
PMID: 27770774DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xu Yao
Hunan Children's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2015
First Posted
December 28, 2015
Study Start
August 1, 2015
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
October 22, 2020
Record last verified: 2020-10