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Autologous Micro-fragmented Adipose Tissue Injection for Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Lipogems
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age of eighteen or older
  • Diagnosis of symptomatic knee osteoarthritis
  • Radiographic evidence of knee osteoarthritis
  • Failure of conservative treatment

Exclusion Criteria:

  • Treatment with any intra-articular knee injection within 8 weeks before surgery
  • Any disease or condition potential to interfere study outcome
  • Under 18 years of age

Sites / Locations

  • Second affiliated hospital, school of medicine, Zhejiang Uni.Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

injection

Arm Description

Outcomes

Primary Outcome Measures

Change in Visual Analog Pain Scale (VAS) Over Time
Scaled pain score to assess change in a patient's knee pain over time. Pain level is marked on a 100 mm line with the 0 mm corresponding to "no pain" and the 100 mm corresponding to 10/10 pain. Using a ruler, the score is determined by measuring the distance (mm) on the 100 mm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).

Secondary Outcome Measures

Change in the knee injury and osteoarthritis score (KOOS) Over Time
Patient self-reported outcome measure to assess the patient's opinion about their knee and associated issues. KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated by adding the subscales together.

Full Information

First Posted
November 14, 2018
Last Updated
April 12, 2019
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT03788265
Brief Title
Autologous Micro-fragmented Adipose Tissue Injection for Knee Osteoarthritis
Official Title
Efficacy of Autologous Micro-fragmented Adipose Tissue Intra-articular Injection for Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
January 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

5. Study Description

Brief Summary
Knee osteoarthritis (OA) is characterized by loss of cartilage leading to instability, reduced range of motion, and functional limitations. Current treatment has various limitations so that alternative options to restore function and alleviate joint pain, with the ultimate goal of healing damaged articular cartilage are needed. Mesenchymal stem cells (MSCs) therapy has shown promising results. However, MSCs are limited by complex regulatory issues. Lipogems is a technique to harvest, process, and inject minimally manipulated adipose tissue through mild mechanical force. This procedure is enzyme free and requires no clonal expansion or manipulation. The goal of this study is to evaluate the possible benefits of reduced joint pain and increased joint functionality in patients with knee osteoarthritis after the injection of Lipogems.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
injection
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Lipogems
Intervention Description
harvest and inject micro-fragment adipose tissue
Primary Outcome Measure Information:
Title
Change in Visual Analog Pain Scale (VAS) Over Time
Description
Scaled pain score to assess change in a patient's knee pain over time. Pain level is marked on a 100 mm line with the 0 mm corresponding to "no pain" and the 100 mm corresponding to 10/10 pain. Using a ruler, the score is determined by measuring the distance (mm) on the 100 mm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
Time Frame
Pre-op, then post-op: 1 month, 3 months, 6 months, 1 year, 2 years
Secondary Outcome Measure Information:
Title
Change in the knee injury and osteoarthritis score (KOOS) Over Time
Description
Patient self-reported outcome measure to assess the patient's opinion about their knee and associated issues. KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated by adding the subscales together.
Time Frame
Pre-op, then post-op: 1 month, 3 months, 6 months, 1 year, 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age of eighteen or older Diagnosis of symptomatic knee osteoarthritis Radiographic evidence of knee osteoarthritis Failure of conservative treatment Exclusion Criteria: Treatment with any intra-articular knee injection within 8 weeks before surgery Any disease or condition potential to interfere study outcome Under 18 years of age
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xuesong Dai, MD., PhD
Phone
+8687783777
Facility Information:
Facility Name
Second affiliated hospital, school of medicine, Zhejiang Uni.
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310058
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuesong Dai
Phone
+8687783777

12. IPD Sharing Statement

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Autologous Micro-fragmented Adipose Tissue Injection for Knee Osteoarthritis

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