ISRCTN88966184进行中（未招募）2 期
Comprehensive analysis of knee osteoarthritis treatment with microfragmented adipose tissue: A double-blinded randomized controlled trial
St Catherine Specialty Hospital0 个研究点目标入组 80 人开始时间: 2022年8月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients with osteoarthritis of the knee who are aged 30-75 years old
- •2. Osteoarthritis grade 2-3 based on Kellgren-Lawrence classification
- •3. Patellofemoral osteoarthritis Iwano grade 2-3
- •4. Presence of knee pain for at least six months
- •5. Patients who have lower limb axis deviation less than 5°
- •6. The possibility of following research instructions and responding to control examinations
- •7. Signed informed consent for participation in the research
排除标准
- •1. Malignant diseases, systemic inflammatory diseases (e.g. rheumatoid arthritis, psoriatic arthritis) or other systemic diseases that can result in knee pain or cause systemic inflammation
- •2. A body mass index (BMI) greater than 30 or diabetes
- •3. Six or more painful points on the body, distributed above and below the waist, on both sides of the body and in the axilla
- •4. Depression (determined according to the CESD-R questionnaire)
- •5. Stage 4 of the Kellgren-Lawrence classification for knee osteoarthritis, stage 4 of the Iwano classification of patellofemoral arthrosis
- •6. A MOAKS score for synovitis or effusion less than 2 (patients without knee effusion)
- •7. Post-traumatic osteoarthritis
- •8. A history of surgery on the affected knee
- •9. A deviation of the mechanical axis (valgus/varus) of the lower extremities greater than 5°
- •10. An unstable knee
- •11. Damage to the meniscus or other knee structures as the main cause of pain and other symptoms (radial rupture and bucket-handle rupture of the meniscus, ACL rupture, subchondral cysts according to MRI)
- •12. An injury of the affected knee in the last 3 months
- •13. Received an intra-articular injection in the affected knee (corticosteroids, hyaluronic acid, platelet-rich plasma, etc.) within the last 3 months
- •14. Other musculoskeletal problems/diseases (genetic diseases such as Marfan syndrome or osteogenesis imperfecta) that would prevent clinical evaluation of the effects of MFAT or HA treatment
- •15. Unable to abstain from oral non-steroidal anti-inflammatory drugs (NSAIDs) for 7 days prior to MFAT or HA application and during the 6-month follow-up
- •16. Allergy to lidocaine and adrenaline
- •17. A blood coagulation disorder, thrombocytopenia or patients on anticoagulant therapy with a prothrombin time <0.70
- •18. Systemic immunosuppressive therapy
- •19. Chondromatosis or villonodular synovitis of the knee joint
- •20. Knee joint infection
- •21. Pregnancy or planning to become pregnant during the study period
- •22. History of chemotherapy or radiotherapy of the extremities or in the area of fat tissue extraction
- •23. Mental illnesses (who cannot be expected to cooperate during the project)
- •24. Unable to respond to follow-up examinations
研究者
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