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临床试验/NCT03527693
NCT03527693已完成不适用

Retrospective Observational Study on the Treatment of Knee Chondral Lesions in Arthroscopy With Autologous and Micro-fragmented Adipose Tissue

Spotorno Foundation0 个研究点目标入组 38 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
38
主要终点
Clinical improvement documented with KOOS (Knee Injury and Osteoarthritis Outcome Score).

研究概览

简要总结

The study aims to evaluate the effects of a single intra-articular injection of micro-fragmented adipose tissue obtained with the Lipogems® system in patients affected by knee chondropathy. End-points were determined by evaluating the patients in terms of improvement in symptoms, functional recovery and radiographic appearance compared to baseline.

详细描述

Background: The social impact of degenerative diseases is steadily increasing, because of the continued rise in the mean age of the active population. Articular cartilage lesions are generally associated with disability and symptoms such as joint pain and reduced function, and remain a challenge for the orthopaedic surgeon. Several non-invasive solution have been proposed, but the results achieved to date are far from being completely satisfactory. Recently, new therapeutic approaches, such as the use of mesenchymal stem cells, have been developed. Among the many sources, the adipose tissue is nowadays considered one of the smartest, due to its abundance and easy access.

The aim of this retrospective study is to explore whether patients affected by symptomatic knee osteoarthritis treated with micro-fragmented adipose tissue associated with a chondral shaving procedure experience an improvement in symptoms and function.

Methods: Thirty-eight consecutive patients affected by symptomatic knee osteoarthritis were treated in 2015 with an arthroscopic procedure associated with an injection of autologous and micro-fragmented adipose tissue. Micro-fragmented adipose tissue was obtained using a minimal manipulation technique in a closed system. Clinical outcomes were determined at 1, 3, 6, and 12 months follow-up using Knee Injury and Osteoarthritis Outcome Score questionnaire and direct physical examination. Safety of the procedure, recording type and incidence of any adverse event, was also assessed.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • knee chondropathy grade > II (ICRS classification),
  • constant pain and failure of conservative treatments (physiokinesitherapy, corticosteroids, HA and/or PRP) for at least 12 months.

排除标准

  • immune-mediated (non-infectious) synovitis
  • OA Kellgren-Lawrence grade >3
  • axial defects >10°
  • metabolic disorders
  • BMI > 40

结局指标

主要结局

Clinical improvement documented with KOOS (Knee Injury and Osteoarthritis Outcome Score).

时间窗: 12 months

Change in one or more of the 5 KOOS sub-scales (worst 0 - best 100) from baseline evaluation to 12 months follow-up. A minimum of 10 points improvement is considered a clinically relevant change.

次要结局

  • Incidence of treatment-related adverse events (AE)(12 months)

研究者

发起方
Spotorno Foundation
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gabriele Cattaneo

Doctor

Spotorno Foundation

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