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| Name | Class |
|---|---|
| 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 |
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The study aims to evaluate the clinical result of Combined Surgery in Management of Congenital Pseudarthrosis.
The study aims to evaluate the clinical result of Combined Surgery in Management of Congenital Pseudarthrosis. The combined surgery includes sleeve resection of the pathological soft tissues, retrograde intramedullary rodding, packaged lilac bone autograft,and appliance of llizarov external fixation device. Bone uion rate,average time of healing, Healing index, ankle valgus, limb length discrepancy, tibia axis alignment are recorded and evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| combined surgery | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| llizarov external fixation device | Device | llizarov external fixation device was applied to fix the tibia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Residual Deformity-Limb length discrepancy |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haibo Mei, M.D. | Contact | 008613975197731 | meihaibo8@163.com | |
| Kewei Wang, M.D | Contact | 008673185600908 | wangkw78@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xu Yao | Hunan Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Children's Hospital | Recruiting | Changsha | Hunan | 410007 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15718906 | Background | 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. | |
| 10868357 | Background | 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. |
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| ID | Term |
|---|---|
| D005594 | Fracture Fixation, Intramedullary |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D005593 | Fracture Fixation, Internal |
| D005592 | Fracture Fixation |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
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| 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 |
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| intramedullary rod fixation | Device | retrograde intramedullary rod was applied to stabilize the tibia. |
|
|
| surgery | Procedure | 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. |
|
|
| 3,6,9,12,18,24 months post-operation |
| 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 |
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 |
| 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 |
| 12377911 | Background | 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. |
| 6373777 | Background | 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. |
| 19308541 | Background | 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. |
| 27770774 | Derived | 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. |