Autologous Micro-fragmented Adipose Tissue Injection for Knee Osteoarthritis

Not Applicable

• Conditions: Knee Osteoarthritis
• Interventions: Device: Lipogems

• Registration Number: NCT03788265
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2018-11-14
• Study First Submitted QC: 2018-12-25
• Study First Posted: 2018-12-27
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-12
• Last Update Posted: 2019-04-16
• Primary Completion: 2020-01-01
• Study Completion: 2021-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
injection	Lipogems	-

Primary Outcome Measures

Name	Time	Method
Change in Visual Analog Pain Scale (VAS) Over Time	Pre-op, then post-op: 1 month, 3 months, 6 months, 1 year, 2 years	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

Name	Time	Method
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	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.

Trial Locations

Locations (1)

Second affiliated hospital, school of medicine, Zhejiang Uni.; 🇨🇳 Hangzhou, Zhejiang, China