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Effectiveness of Autologous Adipose-derived Stem Cells in the Treatment of Knee Cartilage Injury

Primary Purpose

Knee Osteoarthritis, Cartilage Degeneration

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Autologous Adipose-derived Mesenchymal Stem Cell Gel
Sodium Hyaluronate
Extraction of abdominal fat
Sponsored by
Qilu Hospital of Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee Osteoarthritis, Stem Cell, Cartilage repair

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 18-65 years, male and female, patient can tolerate surgery;
  • Clinical diagnosis of degenerative arthritis by Radiographic Criteria;
  • Obviously extra-articular malformation;
  • Good contralateral interventricular cartilage;
  • Course of disease ≥ six months;
  • There was no obvious abnormality in tumor marker detection,or patient was evaluated has not at the risk of cancer;
  • Subjects who understand and sign the consent form for this study.

Exclusion Criteria:

  • Acute joint injury;
  • Patients with severe primary diseases, such as cardiovascular,cerebrovascular, liver, kidney and hematopoietic system, and psychosis;
  • Cancer patients;
  • Women who are pregnant or breast feeding,or allergic constitution patient;
  • Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg, Anti-Hepatitis C virus -Ab), Hepatitis C (Anti-hepatitis C virus -Ab) and syphilis;
  • Receive other open surgery related to knee operation within 6 months;
  • Participation in another clinical trial;
  • Failing to comply with the inclusion criteria, unwilling to comply with the research approach, or incomplete data affecting the curative effect or safety judgment.

Sites / Locations

  • Qilu hospital of Shandong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Autologous Adipose-derived Mesenchymal Stem Cell Gel

sodium hyaluronate

Arm Description

The experimental group received intra-articular injection of Autologous Adipose-derived Mesenchymal Stem Cell Gel one month after operation.

The control group received intra-articular injection of sodium hyaluronate one month after operation.

Outcomes

Primary Outcome Measures

Hospital for special surgery knee score postoperative 1 month
Hospital for special surgery knee score is a knee function scoring system with a full score of 100. 0 means the loss of knee function, 100 means the best knee function, and the greater the value, the better knee function.
Hospital for special surgery knee score postoperative 3 month
Hospital for special surgery knee score is a knee function scoring system with a full score of 100. 0 means the loss of knee function, 100 means the best knee function, and the greater the value, the better knee function.
Hospital for special surgery knee score postoperative 6 month
Hospital for special surgery knee score is a knee function scoring system with a full score of 100. 0 means the loss of knee function, 100 means the best knee function, and the greater the value, the better knee function.
Hospital for special surgery knee score postoperative 12 month
Hospital for special surgery knee score is a knee function scoring system with a full score of 100. 0 means the loss of knee function, 100 means the best knee function, and the greater the value, the better knee function.
Hospital for special surgery knee score postoperative 24 month
Hospital for special surgery knee score is a knee function scoring system with a full score of 100. 0 means the loss of knee function, 100 means the best knee function, and the greater the value, the better knee function.
Hospital for special surgery knee score postoperative 36 month
Hospital for special surgery knee score is a knee function scoring system with a full score of 100. 0 means the loss of knee function, 100 means the best knee function, and the greater the value, the better knee function.
Visual Analogue Scale Postoperative Day 1
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Visual Analogue Scale Postoperative Day 2
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Visual Analogue Scale Postoperative Day 3
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Visual Analogue Scale Postoperative Day 7
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Visual Analogue Scale Postoperative 1 month
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Visual Analogue Scale Postoperative 3 month
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Visual Analogue Scale Postoperative 6 month
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Visual Analogue Scale Postoperative 12 month
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Visual Analogue Scale Postoperative Day One
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Visual Analogue Scale Postoperative 24 month
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Visual Analogue Scale Postoperative 36 month
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Evaluation of cartilage repair under MRI postoperative 12 month
Recht criterion was used for grading articular cartilage injury of knee joint, including 0-IV grade, in which: 0 grade, normal articular cartilage, no obvious abnormal signal was found; 1 grade, the layered structure of cartilage disappeared, and there were focal low signal areas, but the surface was smooth; 2 grade, the surface of cartilage was irregular, the depth of cartilage injury was less than 50% cartilage thickness; 3 grade, the surface of cartilage was heavy. The degree of injury is irregular, the depth of injury is more than 50% of the thickness of cartilage or through the whole layer, but the surface of cartilage is not completely exfoliated; Grade IV, full-thickness cartilage defect, articular cartilage injury deep to the cortex, subchondral bone exposed.
Evaluation of cartilage repair under MRI postoperative 24 month
Recht criterion was used for grading articular cartilage injury of knee joint, including 0-IV grade, in which: 0 grade, normal articular cartilage, no obvious abnormal signal was found; 1 grade, the layered structure of cartilage disappeared, and there were focal low signal areas, but the surface was smooth; 2 grade, the surface of cartilage was irregular, the depth of cartilage injury was less than 50% cartilage thickness; 3 grade, the surface of cartilage was heavy. The degree of injury is irregular, the depth of injury is more than 50% of the thickness of cartilage or through the whole layer, but the surface of cartilage is not completely exfoliated; Grade IV, full-thickness cartilage defect, articular cartilage injury deep to the cortex, subchondral bone exposed.
Evaluation of cartilage repair under MRI postoperative 36 month
Recht criterion was used for grading articular cartilage injury of knee joint, including 0-IV grade, in which: 0 grade, normal articular cartilage, no obvious abnormal signal was found; 1 grade, the layered structure of cartilage disappeared, and there were focal low signal areas, but the surface was smooth; 2 grade, the surface of cartilage was irregular, the depth of cartilage injury was less than 50% cartilage thickness; 3 grade, the surface of cartilage was heavy. The degree of injury is irregular, the depth of injury is more than 50% of the thickness of cartilage or through the whole layer, but the surface of cartilage is not completely exfoliated; Grade IV, full-thickness cartilage defect, articular cartilage injury deep to the cortex, subchondral bone exposed.
Degree of meniscus injury under MRI postoperative 12 month
Stoller's criteria were used in the classification of meniscal injuries, including 0-3 grades, in which: 0 grade, the shape of meniscus was regular, complete and even low signal; 1 grade, focal ellipse or circular high signal appeared in the meniscus, which did not extend to the articular surface and margin of the meniscus; 2 grade, the meniscus showed horizontal linear high signal extending to the articular margin of the meniscus. But it did not exceed the articular surface; in grade III, the shape of meniscus was irregular and incomplete. Irregular or linear high signal appeared in the meniscus and extended to the articular surface of meniscus. The grade I and II symptoms of meniscus injury were mild, suggesting meniscus degeneration, and grade III suggesting meniscus tear.
Degree of meniscus injury under MRI postoperative 24 month
Stoller's criteria were used in the classification of meniscal injuries, including 0-3 grades, in which: 0 grade, the shape of meniscus was regular, complete and even low signal; 1 grade, focal ellipse or circular high signal appeared in the meniscus, which did not extend to the articular surface and margin of the meniscus; 2 grade, the meniscus showed horizontal linear high signal extending to the articular margin of the meniscus. But it did not exceed the articular surface; in grade III, the shape of meniscus was irregular and incomplete. Irregular or linear high signal appeared in the meniscus and extended to the articular surface of meniscus. The grade I and II symptoms of meniscus injury were mild, suggesting meniscus degeneration, and grade III suggesting meniscus tear.
Degree of meniscus injury under MRI postoperative 36 month
Stoller's criteria were used in the classification of meniscal injuries, including 0-3 grades, in which: 0 grade, the shape of meniscus was regular, complete and even low signal; 1 grade, focal ellipse or circular high signal appeared in the meniscus, which did not extend to the articular surface and margin of the meniscus; 2 grade, the meniscus showed horizontal linear high signal extending to the articular margin of the meniscus. But it did not exceed the articular surface; in grade III, the shape of meniscus was irregular and incomplete. Irregular or linear high signal appeared in the meniscus and extended to the articular surface of meniscus. The grade I and II symptoms of meniscus injury were mild, suggesting meniscus degeneration, and grade III suggesting meniscus tear.
Evaluation of cartilage repair under arthroscope postoperative 12 month
The arthroscopic classification of knee joint cartilage injury refers to the classification criteria formulated by the International Association of Cartilage Repair, which includes 0-IV grades, of which: 0 grade is normal articular cartilage; 1 grade is the surface injury of cartilage with soft edema on the surface, with only small cracks and intact structure; 2 grade is partial cartilage injury, which extends downward from the surface, but the depth of injury is less than 50% cartilage thickness. Grade III, deep articular injury, injury depth > 50% cartilage thickness or through the whole layer; Grade IV, deep articular cartilage injury to the bone cortex, full-thickness cartilage defect, subchondral bone exposure.
Degree of meniscus injury under arthroscope postoperative 12 month
The degree of meniscus injury under arthroscopy was classified into three grades, including normal, degenerative and tear.

Secondary Outcome Measures

Squatting to Standing Time postoperative 1 month
The patient squatted on the floor and then stood up completely for five consecutive times, recording the time required.
Squatting to Standing Time postoperative 3 month
The patient squatted on the floor and then stood up completely for five consecutive times, recording the time required.
Squatting to Standing Time postoperative 6 month
The patient squatted on the floor and then stood up completely for five consecutive times, recording the time required.
Squatting to Standing Time postoperative 12 month
The patient squatted on the floor and then stood up completely for five consecutive times, recording the time required.
Squatting to Standing Time postoperative 24 month
The patient squatted on the floor and then stood up completely for five consecutive times, recording the time required.
Squatting to Standing Time postoperative 36 month
The patient squatted on the floor and then stood up completely for five consecutive times, recording the time required.

Full Information

First Posted
May 14, 2019
Last Updated
September 15, 2020
Sponsor
Qilu Hospital of Shandong University
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1. Study Identification

Unique Protocol Identification Number
NCT03955497
Brief Title
Effectiveness of Autologous Adipose-derived Stem Cells in the Treatment of Knee Cartilage Injury
Official Title
Efficacy and Safety Research of Autologous Adipose-derived Mesenchymal Stem Cell Gel in the Treatment of Cartilage Damage in the Knee
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Hospital of Shandong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study was aimed to evaluate the efficacy and safety of Autologous Adipose-derived Mesenchymal Stem Cell Gel combine with High tibial osteotomy therapy in the treatment of cartilage damage in the knee. Investigator believe that this method will enable patients to recover better knee function and more repair of knee cartilage.
Detailed Description
The patients who will underwent high tibial osteotomy were randomly divided into the experimental group and the control group. Abdominal fat extraction before operation in experimental group to prepare Adipose-derived Mesenchymal Stem Cell Gel, while the control group only underwent high tibial osteotomy. One month after operation, the experimental group was injected with Adipose-derived Mesenchymal Stem Cell Gel into the joint cavity, and the control group was injected with sodium hyaluronate in the joint cavity. Two groups of patients were followed up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Cartilage Degeneration
Keywords
Knee Osteoarthritis, Stem Cell, Cartilage repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Autologous Adipose-derived Mesenchymal Stem Cell Gel
Arm Type
Experimental
Arm Description
The experimental group received intra-articular injection of Autologous Adipose-derived Mesenchymal Stem Cell Gel one month after operation.
Arm Title
sodium hyaluronate
Arm Type
Placebo Comparator
Arm Description
The control group received intra-articular injection of sodium hyaluronate one month after operation.
Intervention Type
Other
Intervention Name(s)
Autologous Adipose-derived Mesenchymal Stem Cell Gel
Intervention Description
The experimental group received intra-articular injection of Autologous Adipose-derived Mesenchymal Stem Cell Gel one month after operation.
Intervention Type
Drug
Intervention Name(s)
Sodium Hyaluronate
Other Intervention Name(s)
hyaluronic acid
Intervention Description
The control group received intra-articular injection of sodium hyaluronate one month after operation.
Intervention Type
Procedure
Intervention Name(s)
Extraction of abdominal fat
Other Intervention Name(s)
Fat extraction
Intervention Description
In the experimental group, abdominal fat was extracted before operation to prepare Autologous Adipose-derived Mesenchymal Stem Cell Gel.
Primary Outcome Measure Information:
Title
Hospital for special surgery knee score postoperative 1 month
Description
Hospital for special surgery knee score is a knee function scoring system with a full score of 100. 0 means the loss of knee function, 100 means the best knee function, and the greater the value, the better knee function.
Time Frame
postoperative 1 month
Title
Hospital for special surgery knee score postoperative 3 month
Description
Hospital for special surgery knee score is a knee function scoring system with a full score of 100. 0 means the loss of knee function, 100 means the best knee function, and the greater the value, the better knee function.
Time Frame
postoperative 3 month
Title
Hospital for special surgery knee score postoperative 6 month
Description
Hospital for special surgery knee score is a knee function scoring system with a full score of 100. 0 means the loss of knee function, 100 means the best knee function, and the greater the value, the better knee function.
Time Frame
postoperative 6 month
Title
Hospital for special surgery knee score postoperative 12 month
Description
Hospital for special surgery knee score is a knee function scoring system with a full score of 100. 0 means the loss of knee function, 100 means the best knee function, and the greater the value, the better knee function.
Time Frame
postoperative 12 month
Title
Hospital for special surgery knee score postoperative 24 month
Description
Hospital for special surgery knee score is a knee function scoring system with a full score of 100. 0 means the loss of knee function, 100 means the best knee function, and the greater the value, the better knee function.
Time Frame
postoperative 24 month
Title
Hospital for special surgery knee score postoperative 36 month
Description
Hospital for special surgery knee score is a knee function scoring system with a full score of 100. 0 means the loss of knee function, 100 means the best knee function, and the greater the value, the better knee function.
Time Frame
postoperative 36 month
Title
Visual Analogue Scale Postoperative Day 1
Description
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Time Frame
Postoperative Day 1
Title
Visual Analogue Scale Postoperative Day 2
Description
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Time Frame
Postoperative Day 2
Title
Visual Analogue Scale Postoperative Day 3
Description
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Time Frame
Postoperative Day 3
Title
Visual Analogue Scale Postoperative Day 7
Description
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Time Frame
Postoperative Day 7
Title
Visual Analogue Scale Postoperative 1 month
Description
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Time Frame
Postoperative 1 month
Title
Visual Analogue Scale Postoperative 3 month
Description
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Time Frame
Postoperative 3 month
Title
Visual Analogue Scale Postoperative 6 month
Description
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Time Frame
Postoperative 6 month
Title
Visual Analogue Scale Postoperative 12 month
Description
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Time Frame
Postoperative 12 month
Title
Visual Analogue Scale Postoperative Day One
Description
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Time Frame
Postoperative Day One
Title
Visual Analogue Scale Postoperative 24 month
Description
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Time Frame
Postoperative 24month
Title
Visual Analogue Scale Postoperative 36 month
Description
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Time Frame
Postoperative 36 month
Title
Evaluation of cartilage repair under MRI postoperative 12 month
Description
Recht criterion was used for grading articular cartilage injury of knee joint, including 0-IV grade, in which: 0 grade, normal articular cartilage, no obvious abnormal signal was found; 1 grade, the layered structure of cartilage disappeared, and there were focal low signal areas, but the surface was smooth; 2 grade, the surface of cartilage was irregular, the depth of cartilage injury was less than 50% cartilage thickness; 3 grade, the surface of cartilage was heavy. The degree of injury is irregular, the depth of injury is more than 50% of the thickness of cartilage or through the whole layer, but the surface of cartilage is not completely exfoliated; Grade IV, full-thickness cartilage defect, articular cartilage injury deep to the cortex, subchondral bone exposed.
Time Frame
Postoperative 12 month
Title
Evaluation of cartilage repair under MRI postoperative 24 month
Description
Recht criterion was used for grading articular cartilage injury of knee joint, including 0-IV grade, in which: 0 grade, normal articular cartilage, no obvious abnormal signal was found; 1 grade, the layered structure of cartilage disappeared, and there were focal low signal areas, but the surface was smooth; 2 grade, the surface of cartilage was irregular, the depth of cartilage injury was less than 50% cartilage thickness; 3 grade, the surface of cartilage was heavy. The degree of injury is irregular, the depth of injury is more than 50% of the thickness of cartilage or through the whole layer, but the surface of cartilage is not completely exfoliated; Grade IV, full-thickness cartilage defect, articular cartilage injury deep to the cortex, subchondral bone exposed.
Time Frame
Postoperative 24 month
Title
Evaluation of cartilage repair under MRI postoperative 36 month
Description
Recht criterion was used for grading articular cartilage injury of knee joint, including 0-IV grade, in which: 0 grade, normal articular cartilage, no obvious abnormal signal was found; 1 grade, the layered structure of cartilage disappeared, and there were focal low signal areas, but the surface was smooth; 2 grade, the surface of cartilage was irregular, the depth of cartilage injury was less than 50% cartilage thickness; 3 grade, the surface of cartilage was heavy. The degree of injury is irregular, the depth of injury is more than 50% of the thickness of cartilage or through the whole layer, but the surface of cartilage is not completely exfoliated; Grade IV, full-thickness cartilage defect, articular cartilage injury deep to the cortex, subchondral bone exposed.
Time Frame
Postoperative 36 month
Title
Degree of meniscus injury under MRI postoperative 12 month
Description
Stoller's criteria were used in the classification of meniscal injuries, including 0-3 grades, in which: 0 grade, the shape of meniscus was regular, complete and even low signal; 1 grade, focal ellipse or circular high signal appeared in the meniscus, which did not extend to the articular surface and margin of the meniscus; 2 grade, the meniscus showed horizontal linear high signal extending to the articular margin of the meniscus. But it did not exceed the articular surface; in grade III, the shape of meniscus was irregular and incomplete. Irregular or linear high signal appeared in the meniscus and extended to the articular surface of meniscus. The grade I and II symptoms of meniscus injury were mild, suggesting meniscus degeneration, and grade III suggesting meniscus tear.
Time Frame
postoperative 12 month
Title
Degree of meniscus injury under MRI postoperative 24 month
Description
Stoller's criteria were used in the classification of meniscal injuries, including 0-3 grades, in which: 0 grade, the shape of meniscus was regular, complete and even low signal; 1 grade, focal ellipse or circular high signal appeared in the meniscus, which did not extend to the articular surface and margin of the meniscus; 2 grade, the meniscus showed horizontal linear high signal extending to the articular margin of the meniscus. But it did not exceed the articular surface; in grade III, the shape of meniscus was irregular and incomplete. Irregular or linear high signal appeared in the meniscus and extended to the articular surface of meniscus. The grade I and II symptoms of meniscus injury were mild, suggesting meniscus degeneration, and grade III suggesting meniscus tear.
Time Frame
postoperative 24 month
Title
Degree of meniscus injury under MRI postoperative 36 month
Description
Stoller's criteria were used in the classification of meniscal injuries, including 0-3 grades, in which: 0 grade, the shape of meniscus was regular, complete and even low signal; 1 grade, focal ellipse or circular high signal appeared in the meniscus, which did not extend to the articular surface and margin of the meniscus; 2 grade, the meniscus showed horizontal linear high signal extending to the articular margin of the meniscus. But it did not exceed the articular surface; in grade III, the shape of meniscus was irregular and incomplete. Irregular or linear high signal appeared in the meniscus and extended to the articular surface of meniscus. The grade I and II symptoms of meniscus injury were mild, suggesting meniscus degeneration, and grade III suggesting meniscus tear.
Time Frame
postoperative 36 month
Title
Evaluation of cartilage repair under arthroscope postoperative 12 month
Description
The arthroscopic classification of knee joint cartilage injury refers to the classification criteria formulated by the International Association of Cartilage Repair, which includes 0-IV grades, of which: 0 grade is normal articular cartilage; 1 grade is the surface injury of cartilage with soft edema on the surface, with only small cracks and intact structure; 2 grade is partial cartilage injury, which extends downward from the surface, but the depth of injury is less than 50% cartilage thickness. Grade III, deep articular injury, injury depth > 50% cartilage thickness or through the whole layer; Grade IV, deep articular cartilage injury to the bone cortex, full-thickness cartilage defect, subchondral bone exposure.
Time Frame
postoperative 12 month
Title
Degree of meniscus injury under arthroscope postoperative 12 month
Description
The degree of meniscus injury under arthroscopy was classified into three grades, including normal, degenerative and tear.
Time Frame
postoperative 12 month
Secondary Outcome Measure Information:
Title
Squatting to Standing Time postoperative 1 month
Description
The patient squatted on the floor and then stood up completely for five consecutive times, recording the time required.
Time Frame
postoperative 1 month
Title
Squatting to Standing Time postoperative 3 month
Description
The patient squatted on the floor and then stood up completely for five consecutive times, recording the time required.
Time Frame
postoperative 3 month
Title
Squatting to Standing Time postoperative 6 month
Description
The patient squatted on the floor and then stood up completely for five consecutive times, recording the time required.
Time Frame
postoperative 6 month
Title
Squatting to Standing Time postoperative 12 month
Description
The patient squatted on the floor and then stood up completely for five consecutive times, recording the time required.
Time Frame
postoperative 12 month
Title
Squatting to Standing Time postoperative 24 month
Description
The patient squatted on the floor and then stood up completely for five consecutive times, recording the time required.
Time Frame
postoperative 24 month
Title
Squatting to Standing Time postoperative 36 month
Description
The patient squatted on the floor and then stood up completely for five consecutive times, recording the time required.
Time Frame
postoperative 36 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18-65 years, male and female, patient can tolerate surgery; Clinical diagnosis of degenerative arthritis by Radiographic Criteria; Obviously extra-articular malformation; Good contralateral interventricular cartilage; Course of disease ≥ six months; There was no obvious abnormality in tumor marker detection,or patient was evaluated has not at the risk of cancer; Subjects who understand and sign the consent form for this study. Exclusion Criteria: Acute joint injury; Patients with severe primary diseases, such as cardiovascular,cerebrovascular, liver, kidney and hematopoietic system, and psychosis; Cancer patients; Women who are pregnant or breast feeding,or allergic constitution patient; Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg, Anti-Hepatitis C virus -Ab), Hepatitis C (Anti-hepatitis C virus -Ab) and syphilis; Receive other open surgery related to knee operation within 6 months; Participation in another clinical trial; Failing to comply with the inclusion criteria, unwilling to comply with the research approach, or incomplete data affecting the curative effect or safety judgment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Songlin Li, MD
Phone
0531-82166541
Email
bysonglin@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Heran Ma, Ph.D
Phone
+86 17364590020
Email
2523129824@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peilai Liu, MD
Organizational Affiliation
Qilu Hospital of Shandong University
Official's Role
Study Chair
Facility Information:
Facility Name
Qilu hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Songlin Li, MD
Phone
053182166541
Email
bysonglin@126.com
First Name & Middle Initial & Last Name & Degree
Heran Ma, Ph.D
Phone
+8617364590020
Email
2523129824@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The acquisition of individual participant data needs the consent of Peilai Liu, the person in charge.
Citations:
PubMed Identifier
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Effectiveness of Autologous Adipose-derived Stem Cells in the Treatment of Knee Cartilage Injury

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