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

April 8, 2018 updated by: Ziming Zhang, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Comparison of the Outcomes of the Treatment of Semiepiphysiodesis Using Hinged and Conventional 8-figure Plates: A Randomized Controlled Clinical Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Zhiqiang Zhang, MD
  • Phone Number: +86 18721772513

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 years
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.
2 years
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.
2 years
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ziming Zhang, PhD, Department of Pediatric Orthopedics, Xinhua Hospital affiliated to Shanghai Jiao Tong University, School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 25, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XH-17-013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Genu Valgum or Varum

Clinical Trials on hinged 8-figure plate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings