The Effect of Combined Surgery in Management of Congenital Pseudarthrosis of Tibia

NCT ID: NCT02640040

Last Updated: 2020-10-22

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2025-12-31

Brief Summary

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The study aims to evaluate the clinical result of Combined Surgery in Management of Congenital Pseudarthrosis.

Detailed Description

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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.

Conditions

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Congenital Pseudarthrosis of Tibia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

llizarov external fixation device

Intervention Type DEVICE

llizarov external fixation device was applied to fix the tibia.

intramedullary rod fixation

Intervention Type DEVICE

retrograde intramedullary rod was applied to stabilize the tibia.

surgery

Intervention Type 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.

Interventions

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llizarov external fixation device

llizarov external fixation device was applied to fix the tibia.

Intervention Type DEVICE

intramedullary rod fixation

retrograde intramedullary rod was applied to stabilize the tibia.

Intervention Type DEVICE

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.

Intervention Type PROCEDURE

Other Intervention Names

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llizarov fixator intramedullary rodding combined surgery

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou Women and Children's Medical Center

OTHER

Sponsor Role collaborator

Shenzhen Children's Hospital

OTHER_GOV

Sponsor Role collaborator

Tongji Hospital

OTHER

Sponsor Role collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role collaborator

Wuhan Women and Children's Medical Center

OTHER

Sponsor Role collaborator

Foshan Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Beijing Children's Hospital

OTHER

Sponsor Role collaborator

Dalian Children's Hospital

OTHER

Sponsor Role collaborator

Children's Hospital of Chongqing Medical University

OTHER

Sponsor Role collaborator

Kunming Children's Hospital

OTHER

Sponsor Role collaborator

Hunan Children's Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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China

Central Contacts

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Haibo Mei, M.D.

Role: CONTACT

008613975197731

Kewei Wang, M.D

Role: CONTACT

008673185600908

Facility Contacts

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Haibo Mei, M.D.

Role: primary

008613975197731

Guanghui Zhu, M.D.

Role: backup

008313875864343

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.

Reference Type BACKGROUND
PMID: 15718906 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10868357 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12377911 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6373777 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19308541 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27770774 (View on PubMed)

Other Identifiers

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HN02

Identifier Type: -

Identifier Source: org_study_id

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