Congenital Pseudarthrosis of Tibia Clinical Trial
Official title:
The Effect of Combined Surgery in Management of Congenital Pseudarthrosis of Tibia
| NCT number | NCT02640040 |
| Other study ID # | HN02 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | August 2015 |
| Est. completion date | December 2025 |
The study aims to evaluate the clinical result of Combined Surgery in Management of Congenital Pseudarthrosis.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | December 2025 |
| Est. primary completion date | December 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 2 Years to 18 Years |
| Eligibility | Inclusion Criteria: - The inclusion criteria consists of patients with congenital pseudarthrosis of Tibia 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. - Parents refused further treatment. |
| Country | Name | City | State |
|---|---|---|---|
| China | Hunan Children's Hospital | Changsha | Hunan |
| Lead Sponsor | Collaborator |
|---|---|
| Hunan Children's Hospital | Beijing Children's Hospital, Children's Hospital of Chongqing Medical University, Dalian Children's Hospital, Foshan Hospital of Traditional Chinese Medicine, Guangzhou Women and Children's Medical Center, Kunming Children's Hospital, Shenzhen Children's Hospital, Tongji Hospital, Wuhan Union Hospital, China, Wuhan Women and Children's Medical Center |
China,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Residual Deformity-proximal tibia angulation(range,0°-90°) | measurement of the angulation of proximal tibia in anterior and posterior (AP )and lateral X ray | pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation | |
| Other | Residual Deformity-Limb length discrepancy | measurement of the length difference of both tibia in AP and lateral X ray | pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation | |
| Other | Residual Deformity-ankle valgus angulation(range,0°-90°) | measurement of the angulation between the distal tibia and ankle joint. | pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation | |
| Primary | 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 | clinical outcome measurement(Johnston clinical evaluation criterion) | Johnston clinical evaluation criterion of Congenital Pseudarthrosis of Tibia (CPT): The outcome was classified as grade
1 when there was unequivocal union with full weight-bearing function and maintenance of alignment requiring no additional surgical treatment; grade 2 when there was equivocal union with useful function, with the limb protected by a brace, and/or valgus or sagittal bowing for which additional surgery was required or anticipated; and grade 3 when there was persistent nonunion or refracture, requiring full-time external support for pain and/or instability. |
3,6,9,12,18,24 months post-operation | |
| Secondary | Refracture of tibia | The continuity of tibia cortex was disappeared in X ray. | 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation |
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