Autologous Micro-fragmented Adipose Tissue Injection for Knee Osteoarthritis
Efficacy of Autologous Micro-fragmented Adipose Tissue Intra-articular Injection for Knee Osteoarthritis
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable knee-osteoarthritis
Started Jan 2016
Longer than P75 for not_applicable knee-osteoarthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 14, 2018
CompletedFirst Posted
Study publicly available on registry
December 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedApril 16, 2019
April 1, 2019
4 years
November 14, 2018
April 12, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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).
Pre-op, then post-op: 1 month, 3 months, 6 months, 1 year, 2 years
Secondary Outcomes (1)
Change in the knee injury and osteoarthritis score (KOOS) Over Time
Pre-op, then post-op: 1 month, 3 months, 6 months, 1 year, 2 years
Study Arms (1)
injection
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Age of eighteen or older
- Diagnosis of symptomatic knee osteoarthritis
- Radiographic evidence of knee osteoarthritis
- Failure of conservative treatment
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Second affiliated hospital, school of medicine, Zhejiang Uni.
Hangzhou, Zhejiang, 310058, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2018
First Posted
December 27, 2018
Study Start
January 1, 2016
Primary Completion
January 1, 2020
Study Completion
January 1, 2021
Last Updated
April 16, 2019
Record last verified: 2019-04