The Effect of Combined Surgery in Management of Congenital Pseudarthrosis of Tibia
Primary Purpose
Congenital Pseudarthrosis of Tibia
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
llizarov external fixation device
intramedullary rod fixation
surgery
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Pseudarthrosis of Tibia
Eligibility Criteria
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.
Sites / Locations
- Hunan Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
combined surgery
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Refracture of tibia
The continuity of tibia cortex was disappeared in X ray.
Full Information
NCT ID
NCT02640040
First Posted
August 31, 2015
Last Updated
October 20, 2020
Sponsor
Hunan Children's Hospital
Collaborators
Guangzhou Women and Children's Medical Center, Shenzhen Children's Hospital, Tongji Hospital, Wuhan Union Hospital, China, Wuhan Women and Children's Medical Center, Foshan Hospital of Traditional Chinese Medicine, Beijing Children's Hospital, Dalian Children's Hospital, Children's Hospital of Chongqing Medical University, Kunming Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02640040
Brief Title
The Effect of Combined Surgery in Management of Congenital Pseudarthrosis of Tibia
Official Title
The Effect of Combined Surgery in Management of Congenital Pseudarthrosis of Tibia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Recruiting
Study Start Date
August 2015 (undefined)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hunan Children's Hospital
Collaborators
Guangzhou Women and Children's Medical Center, Shenzhen Children's Hospital, Tongji Hospital, Wuhan Union Hospital, China, Wuhan Women and Children's Medical Center, Foshan Hospital of Traditional Chinese Medicine, Beijing Children's Hospital, Dalian Children's Hospital, Children's Hospital of Chongqing Medical University, Kunming Children's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study aims to evaluate the clinical result of Combined Surgery in Management of Congenital Pseudarthrosis.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Pseudarthrosis of Tibia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
combined surgery
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
llizarov external fixation device
Other Intervention Name(s)
llizarov fixator
Intervention Description
llizarov external fixation device was applied to fix the tibia.
Intervention Type
Device
Intervention Name(s)
intramedullary rod fixation
Other Intervention Name(s)
intramedullary rodding
Intervention Description
retrograde intramedullary rod was applied to stabilize the tibia.
Intervention Type
Procedure
Intervention Name(s)
surgery
Other Intervention Name(s)
combined surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
whether the tibial has obtained union.
Description
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.
Time Frame
6 months post-operation
Secondary Outcome Measure Information:
Title
clinical outcome measurement(Johnston clinical evaluation criterion)
Description
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.
Time Frame
3,6,9,12,18,24 months post-operation
Title
Refracture of tibia
Description
The continuity of tibia cortex was disappeared in X ray.
Time Frame
0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation
Other Pre-specified Outcome Measures:
Title
Residual Deformity-proximal tibia angulation(range,0°-90°)
Description
measurement of the angulation of proximal tibia in anterior and posterior (AP )and lateral X ray
Time Frame
pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation
Title
Residual Deformity-Limb length discrepancy
Description
measurement of the length difference of both tibia in AP and lateral X ray
Time Frame
pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation
Title
Residual Deformity-ankle valgus angulation(range,0°-90°)
Description
measurement of the angulation between the distal tibia and ankle joint.
Time Frame
pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haibo Mei, M.D.
Phone
008613975197731
Email
meihaibo8@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kewei Wang, M.D
Phone
008673185600908
Email
wangkw78@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xu Yao
Organizational Affiliation
Hunan Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hunan Children's Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410007
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haibo Mei, M.D.
Phone
008613975197731
Email
meihaibo8@163.com
First Name & Middle Initial & Last Name & Degree
Guanghui Zhu, M.D.
Phone
008313875864343
Email
zgh5650@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
15718906
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. doi: 10.1097/01.bpo.0000151054.54732.0b.
Results Reference
background
PubMed Identifier
10868357
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. doi: 10.1097/01202412-200004000-00003.
Results Reference
background
PubMed Identifier
12377911
Citation
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.
Results Reference
background
PubMed Identifier
6373777
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. doi: 10.1302/0301-620X.66B3.6373777.
Results Reference
background
PubMed Identifier
19308541
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.
Results Reference
background
PubMed Identifier
27770774
Citation
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.
Results Reference
derived
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The Effect of Combined Surgery in Management of Congenital Pseudarthrosis of Tibia
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