Kinematic Parameters to Predict Knee Diseases.

May 17, 2017 updated by: Yu Zhang, Guangzhou General Hospital of Guangzhou Military Command

Can Gait Parameters Predict Knee Injuries/Arthritis?

There is no study to explore the prediction of knee diseases using kinematic parameters of knee during gait. The aim of this study is to explore the possibility of predicting knee diseases by gait parameters.

Study Overview

Status

Status

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

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.

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.
Observational

Enrollment (Actual)

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.
1914

Contacts and Locations

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

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510010
        • Hospital of Orthopedics, Guangzhou General Hospital of Guangzhou Military Command

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

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All the patients were from January 2013 to March 2017.

Description

Inclusion Criteria:

  1. age> 18 years
  2. body mass index<30;
  3. confirmed radiographically or by surgery to have knee injuries/arthritis;
  4. knee pain in their knees at least one months;
  5. able to walk unaided

Exclusion Criteria:

  1. history of other lower limbs' surgery/injuries/arthritis (hip or ankle);
  2. Corticosteroid or Sodium Hyaluronate injection within 6 months;
  3. neuropathic arthropathy or rheumatoid arthritis;
  4. any other muscular or neurological diseases that affected the condition of the lower limbs;
  5. unable to walk independently;
  6. history of heart disease;
  7. body mass index> 30;
  8. age> 90 years;
  9. unable to finish the procedure

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Normal
This group is control group. Participants in this group do not have knee diseases or any other bad injuries in lower limbs.
Procedure: Observational gait analysis procedure
All the participants underwent a standard observational procedure: i) diagnosed with knee injuries/arthritis; ii) For KOA, take radiographic examination (x-ray) and take gait analysis on a treadmill in barefoot; iii) For knee injuries, take gait analysis before surgery, the disease of patients was confirmed by surgery (knee arthroscopy); iv)Normal people take an physical examination to avoid other disease;
KOA
Participants in this group have knee osteoarthritis and have no other bad injuries in lower limbs.
Procedure: Observational gait analysis procedure
All the participants underwent a standard observational procedure: i) diagnosed with knee injuries/arthritis; ii) For KOA, take radiographic examination (x-ray) and take gait analysis on a treadmill in barefoot; iii) For knee injuries, take gait analysis before surgery, the disease of patients was confirmed by surgery (knee arthroscopy); iv)Normal people take an physical examination to avoid other disease;
ACLD
Participants in this group have anterior cruciate ligament deficiency with or without meniscus deficiency and have no other bad injuries in lower limbs.
Procedure: Observational gait analysis procedure
All the participants underwent a standard observational procedure: i) diagnosed with knee injuries/arthritis; ii) For KOA, take radiographic examination (x-ray) and take gait analysis on a treadmill in barefoot; iii) For knee injuries, take gait analysis before surgery, the disease of patients was confirmed by surgery (knee arthroscopy); iv)Normal people take an physical examination to avoid other disease;
MD
Participants in this group have meniscus deficiency and have no other bad injuries in lower limbs.
Procedure: Observational gait analysis procedure
All the participants underwent a standard observational procedure: i) diagnosed with knee injuries/arthritis; ii) For KOA, take radiographic examination (x-ray) and take gait analysis on a treadmill in barefoot; iii) For knee injuries, take gait analysis before surgery, the disease of patients was confirmed by surgery (knee arthroscopy); iv)Normal people take an physical examination to avoid other disease;
Plica
Participants in this group have plica syndrome and have no other bad injuries in lower limbs.
Procedure: Observational gait analysis procedure
All the participants underwent a standard observational procedure: i) diagnosed with knee injuries/arthritis; ii) For KOA, take radiographic examination (x-ray) and take gait analysis on a treadmill in barefoot; iii) For knee injuries, take gait analysis before surgery, the disease of patients was confirmed by surgery (knee arthroscopy); iv)Normal people take an physical examination to avoid other disease;

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
Knee flexion/extension angle at initial contact during gait.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Knee internal/external rotation angle at initial contact during gait.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Knee adduction/abduction angle at initial contact during gait.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
knee anterior/posterior translation at initial contact during gait.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Knee medial/lateral translation at initial contact during gait.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Knee proximal/distal translation at initial contact during gait.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Knee flexion/extension angle at opposite toe off during gait.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Knee internal/external rotation angle at opposite toe off during gait.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Knee adduction/abduction angle at opposite toe off during gait.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Knee anterior/posterior translation at opposite toe off during gait.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Knee distal/proximal translation at opposite toe off during gait.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Knee medial/lateral translation at opposite toe off during gait.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Knee flexion/extension angle at heel rise during gait.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Knee internal/external rotation angle at heel rise during gait.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Knee adduction/abduction angle at heel rise during gait.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Knee anterior/posterior translation at heel rise during gait.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Knee distal/proximal translation at heel rise during gait.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Knee medial/lateral translation at heel rise during gait.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Knee flexion/extension angle at opposite initial contact during gait.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Knee internal/external angle at opposite initial contact during gait.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Knee adduction/abduction angle at opposite initial contact during gait.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Knee anterior/posterior translation at opposite initial contact during gait.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Knee distal/proximal translation at opposite initial contact during gait.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Knee medial/lateral translation at opposite initial contact during gait.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Knee flexion/extension angle at toe off during gait.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Knee adduction/abduction angle at toe off during gait.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Knee internal/external rotation angle at toe off during gait.
Time Frame: About 15 min
The same as the first primary outcome measure.
About 15 min
Knee anterior/posterior translation at toe off during gait.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Knee distal/proximal translation at toe off during gait.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Knee medial/lateral translation at toe off during gait
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Knee flexion/extension angle at feet adjacent during gait.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Knee internal/external rotation angle at feet adjacent during gait.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Knee adduction/abduction angle at feet adjacent during gait.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Knee anterior/posterior translation at feet adjacent during gait.
Time Frame: About 15 min
The same as the first primary outcome measure.
About 15 min
Knee distal/proximal translation at feet adjacent during gait.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Knee medial/lateral translation at feet adjacent during gait.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Knee flexion/extension angle at tibia vertical during gait.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Knee adduction/abduction angle at tibia vertical during gait.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Knee internal/external rotation angle at tibia vertical during gait.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Knee anterior/posterior translation at tibia vertical during gait.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Knee distal/proximal translation at tibia vertical during gait.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Knee medial/lateral translation at tibia vertical during gait.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Range of motion of knee flexion/extension angle.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Range of motion of knee internal/external rotation angle.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Range of motion of knee adduction/abduction angle.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Range of motion of knee anterior/posterior translation.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Range of motion of knee distal/proximal translation.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min
Range of motion of knee medial/lateral translation.
Time Frame: About 15 min
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
About 15 min

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.
Guangzhou General Hospital of Guangzhou Military Command

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medical Center of Assessment, Prevention and Treatment of Bone & Joint Diseases, Guangdong, China

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 (Actual)

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.
April 20, 2017

Primary Completion (Actual)

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.
May 14, 2017

Study Completion (Actual)

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.
May 17, 2017

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).
April 23, 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.
April 25, 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.
April 26, 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.
May 18, 2017

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.
May 17, 2017

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.
May 1, 2017

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.
  • GuangzhouGH007

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.

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