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Hinged Versus Conventional 8 Plate for Correction of Genu Valgum or Varum

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ClinicalTrials.gov Identifier: NCT03378206
Recruitment Status : Not yet recruiting
First Posted : December 19, 2017
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Ziming Zhang, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary:

To assess the therapeutic effect of hinged 8-figure plate by comparing with the traditional 8-figure plate through a randomized controlled clinical trial by assessing the differences between preoperative and postoperative data.

The hypothesis is that the hinged 8 plate provides low complications that this treatment is as good as the traditional one.


Condition or disease Intervention/treatment Phase
Genu Valgum or Varum Growth; Arrested, Bone Epiphyseal Arrest, Lower Leg Device: hinged 8-figure plate Device: conventional 8-figure plate Not Applicable

Detailed Description:
Angular deformities of the lower limb is major clinical problems encountered in pediatric orthopedics. Deformities can be either valgus or varus and most commonly affect the knee joint, which may result in patella dislocation, gait instability and serious impact on the appearance and function of the lower limbs. Biomechanical studies and gait analysis found that genu varus increased medial articular surface pressure of the knee, while genu valgus increased lateral articular surface pressure, and both of them are the risk factors for osteoarthritis. Surgical treatment techniques include osteotomy and hemiepipysidesis. Osteotomy surgery is the gold standard for severe angular deformity or epiphyseal closed patients, but it was associated with lots of complications, including osteofascial compartment syndrome, neurovascular injury, deep soft tissue infection, nonunion and requiring a long recovery time. While, for patients whose epiphyseal is not closed, the traditional 8 plate hemiepipysidesis has fewer complications. However, it showed some problems in clinical applications, such as steel plate or screw broken. The investigators designed a new hinged 8 plate, which has two arms and a built-in hinge. Based on the previous studies, investigators designed the rotation of the two arms ranged from 155° to 170° to better fit the contour of the physis in all stages of angular correction. That automatic change can also disperse repeated stress on the surface of periosteum and perichondrium during walking. The plate had been tested on animal models that the use of the hinged plate and screw system may be a more reliable technique with minimal complications for correction of angular deformities of the lower limb.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of the Outcomes of the Treatment of Semiepiphysiodesis Using Hinged and Conventional 8-figure Plates: A Randomized Controlled Clinical Trial
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : August 31, 2020

Arm Intervention/treatment
Experimental: Hinged 8-figure plate
Hinged 8-figure plate is a novel devise that has modifications in order to improve the treatment effect of conventional 8-figure plate. This arm will be used to verify the effectiveness and feasibility of the modification.
Device: hinged 8-figure plate
Hinged 8-figure plate has two arms and a built-in hinge. The rotation of the two arms ranged from 155° to 170° to better fit the contour of the physis in all stages of angular correction. That automatic change can also disperse repeated stress on the surface of periosteum and perichondrium during walking.

Active Comparator: conventional 8-figure plate
Conventional 8-figure plate is widespread method to treat genu varum and valgus. This arm, as a comparator, will be the control group to verify the feasibility of the novel hinged 8-figure plate.
Device: conventional 8-figure plate
Conventional 8-figure plate is a widespread device to treat angular deformity of lower limbs with moderate successful rate. The device was designed based on the principle of tension band model. It consists of a plate and two screws (epiphyseal screw and metaphyseal screw).




Primary Outcome Measures :
  1. The complications. [ Time Frame: 2 years ]
    Surgery related complications including osteofascial compartment syndrome, neurovascular injury, deep soft tissue infection and so on will be observed until correction of deformity.


Secondary Outcome Measures :
  1. The corrective rates of medial slope angle. [ Time Frame: 2 years ]
    The angle of medial slope will be measured when reexamination until the correction of deformity, which was used to calculate the corrective rates.

  2. The corrective of Mechanical lateral distal femoral angle. [ Time Frame: 2 years ]
    The corrective of Mechanical lateral distal femoral angle will be measured when reexamination until the correction of deformity. And investigators will calculating the change of this angle.

  3. The movement of two arms of the hinged plate. [ Time Frame: 2 years ]
    The movement of two arms during the experiment will be noted by the changing of two arms angle when reexamination until the correction of deformity.

  4. The residual stress on the implants. [ Time Frame: 2 years ]
    Residual stress (remaining stress of the sample after implant removal) at the rim of the metaphyseal screw hole will be measured using X-ray diffraction.



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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Idiopathic genu valgus or varum
  2. Without any treatment
  3. lower limb mechanical axis over the tibial plateau in the range of 1/2;
  4. Epiphyseal not yet closed, with more than 12 months of growth potential

Exclusion Criteria:

  1. Physiological genu valgus or varum
  2. Epiphyseal have closed or no growth potential
  3. Pathological limb deformity(Blount disease, inflammation,trauma)
  4. Other causes of lower limb angular deformity.
  5. With surgical contraindications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03378206


Contacts
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Contact: Ziming Zhang, PhD +86 13651756906 zmzhang23@163.com
Contact: Zhiqiang Zhang, MD +86 18721772513

Sponsors and Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Ziming Zhang, PhD Department of Pediatric Orthopedics, Xinhua Hospital affiliated to Shanghai Jiao Tong University, School of Medicine

Publications of Results:

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Responsible Party: Ziming Zhang, Deputy director of Department of Pediatric Orthopedics, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03378206     History of Changes
Other Study ID Numbers: XH-17-013
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ziming Zhang, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine:
genu valgum or varum
eight-plate
epiphysis arrest
hemiepiphysiodesis

Additional relevant MeSH terms:
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Genu Valgum
Bone Diseases
Musculoskeletal Diseases