- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03135613
Kinematics of Knees of Patients With Tumor Around Knee After Microwave Ablation With Plate Internal Fixation
April 28, 2017 updated by: Yu Zhang, Guangzhou General Hospital of Guangzhou Military Command
Kinematics of the Healthy Knee and the Surgery Knee in Patients With Tumor Around Knee After Microwave Ablation With Plate Internal Fixation.
The aim of this study is to investigate kinematics of knees of patients with tumor around knee after microwave ablation with plate internal fixation
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- 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
- Name: Limin Ma, PhD
Study Contact Backup
- Name: Yu Zhang, PhD
- Phone Number: +86-20-88654440
- Email: luck_2001@126.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510010
- Recruiting
- Hospital of Orthopedics, Guangzhou General Hospital of Guangzhou Military Command
-
Contact:
- Yu Zhang, PhD
- Email: luck_2001@126.com
-
-
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
Ages Eligible for Study
No older than 40 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age < 40.
- Body mass index < 30.
- For controls, no history of major injury or surgery in lower limbs; no symptoms of lower limbs; physical examination to test the lower limbs to be healthy.
- For MF group, patients With Tumor Around Knee After Microwave Ablation With Plate Internal Fixation for 6 months or more.
Exclusion Criteria:
- Body mass index >30.
- For controls, injury or surgery in hip/knee/ankle.
- For MF group, injury or surgery in hip/ankle;
- Neuropathic disease.
- Muscular disease.
- Lack ability to finish the procedure physically or mentally.
- Easy to fall.
- Any other conditions that can influence gait parameters of the lower limbs.
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: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Normal
Participants of this group are as controls.
|
Once participants are eligible, they will undergo the experimental procedure.
Before data collection, they will walk on a treadmill in barefoot for ten minutes to adapt the condition.
The gait analysis system will collect the data while they walk on the treadmill in barefoot at self-selected gait speed.
|
Experimental: MF
Participants of this group are patients with tumor around knee after microwave ablation with plate internal fixation.
|
Once participants are eligible, they will undergo the experimental procedure.
Before data collection, they will walk on a treadmill in barefoot for ten minutes to adapt the condition.
The gait analysis system will collect the data while they walk on the treadmill in barefoot at self-selected gait speed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knee flexion/extension angle at initial contact during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee internal/external rotation angle at initial contact during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee adduction/abduction angle at initial contact during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee anterior/posterior translation at initial contact during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee medial/lateral translation at initial contact during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee proximal/distal translation at initial contact during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee flexion/extension angle at opposite toe off during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee adduction/abduction angle at opposite toe off during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee internal/external rotation angle at opposite toe off during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee anterior/posterior translation at opposite toe off during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee distal/proximal translation at opposite toe off during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee medial/lateral translation at opposite toe off during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee flexion/extension angle at heel rise during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee internal/external rotation angle at heel rise during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee adduction/abduction angle at heel rise during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee anterior/posterior translation at heel rise during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee distal/proximal translation at heel rise during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee medial/lateral translation at heel rise during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee flexion/extension angle at opposite initial contact during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee adduction/abduction angle at opposite initial contact during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee internal/external rotation angle at opposite initial contact during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee anterior/posterior translation at opposite initial contact during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee distal/proximal translation at opposite initial contact during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee medial/lateral translation at opposite initial contact during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee flexion/extension angle at toe off during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee adduction/abduction angle at toe off during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee internal/external rotation angle at toe off during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee anterior/posterior translation at toe off during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee distal/proximal translation at toe off during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee medial/lateral translation at toe off during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee flexion/extension angle at feet adjacent during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee internal/external rotation angle at feet adjacent during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee adduction/abduction angle at feet adjacent during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee anterior/posterior translation at feet adjacent during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee distal/proximal translation at feet adjacent during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee medial/lateral translation at feet adjacent during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee flexion/extension angle at tibial vertical during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee adduction/abduction angle at tibial vertical during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee internal/external rotation angle at tibial vertical during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee anterior/posterior translation at tibial vertical during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee distal/proximal translation at tibial vertical during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Knee medial/lateral translation at tibial vertical during gait.
Time Frame: 1 Day
|
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.
|
1 Day
|
Range of motion of knee flexion/extension angle.
Time Frame: 1 Day
|
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.
|
1 Day
|
Range of motion of knee adduction/abduction angle.
Time Frame: 1 Day
|
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.
|
1 Day
|
Range of motion of knee internal/external rotation angle.
Time Frame: 1 Day
|
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.
|
1 Day
|
Range of motion of knee anterior/posterior translation.
Time Frame: 1 Day
|
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.
|
1 Day
|
Range of motion of knee distal/proximal translation.
Time Frame: 1 Day
|
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.
|
1 Day
|
Range of motion of knee medial/lateral translation.
Time Frame: 1 Day
|
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.
|
1 Day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
April 26, 2017
Primary Completion (Anticipated)
May 20, 2017
Study Completion (Anticipated)
May 25, 2017
Study Registration Dates
First Submitted
April 26, 2017
First Submitted That Met QC Criteria
April 28, 2017
First Posted (Actual)
May 1, 2017
Study Record Updates
Last Update Posted (Actual)
May 1, 2017
Last Update Submitted That Met QC Criteria
April 28, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GuangzhouGH009
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
product manufactured in and exported from the U.S.
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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