Clinical and Comparative Evaluation of Treatment Results for Osteoarthritis of the Knee in the Form of Chondromalacia of the Articular Cartilage Treated in the Arthroscopic Technique With the Use of: Autogenous Transplant of Fragmented Adipose Tissue Taken From Abdominal Integuments, PRP GF (Platelet-rich Plasma With Growth Factors), Mesenchymal Cells Centrifuged From Bone Marrow Cells Taken From the Iliac Crest, Hyaluronic Acid - Low Molecular Weight, Hyaluronic Acid - Cross-linked
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Tegner Activity Level Scale (TAS)
研究概览
简要总结
The main objective of the research project is to evaluate the results of the treatment of chondromalacia of the cartilage in the knee joint with the use of: autogenous transplantation of fragmented adipose tissue taken from the abdominal wall - (MyStem, Lipogems, Arthrex).
PRP GF (platelet-rich plasma with growth factors) (Ycellbio, ACP Arthrex, Neoregen, FrankPharma), Mesenchymal cells centrifuged from bone marrow cells taken from the iliac crest - (Harvest, Arthrex), Hyaluronic acid - low molecular weight (Synvisc, Biolevox, ArtiAidPlus), Hyaluronic acid - cross-linked Arti Aid Plus, Synovial, Durolain, StavOn, Collagen - Guna, Orthokine.
The specific objectives are: to compare the results of treatment of analogous zones of cartilage defects in the knee joint obtained in the study groups using two methods: microfractures and microfractures with simultaneous intra-articular injection of autogenous cartilage graft and PRP GF (Auto Cart-Arthrex method). The results for the operated limb in both groups will be compared both between the groups and with the results of clinical and biomechanical tests for the non-operated limbs.
详细描述
The study will be prospective, randomized. The study groups will consist of 30 people with damage to analogous cartilage zones of the knee joint qualified for arthroscopic treatment.
After surgery, patients will be improved according to the same rehabilitation protocol.
The follow-up examination will include: subjective assessment and clinical examination on day 1, then after 3 and 6 months, MRI imaging, ultrasound after 6 months, biomechanical examination after 3 and 6 months.
A detailed interview will be conducted in the study groups, supplemented with pain assessment on the 1st day after the procedure using the Visual Analogue Scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), then with the TAS activity level scale (TAS). Tegner Activity Level Scale), three parts of the 2000 International Knee Documentation Committee (2000 IKDC) questionnaire: Demographic Form, Current Health Assessment Form, percentage of drugs used acute treatment initiation, withdrawal rates due to knee pain, knee range of motion, and adverse events.
The MRI examination will be carried out on a 1.5 Tesla apparatus, the ultrasound examination on a apparatus with the option of elastometry and BMI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Surgery for ACL damage to the knee joint;
- •Arthroscopic surgery;
- •No prior knee surgical interventions;
- •No additional pathologies in this anatomical area;
- •Informed consent of the patient to participate in the study.
排除标准
- •Previous surgical interventions in the examined anatomical area;
- •Additional pathologies in this area identified as part of preoperative diagnostics;
- •Damage to the second knee joint;
- •Failure to comply with the rigor of the same rehabilitation treatment protocol.
结局指标
主要结局
Tegner Activity Level Scale (TAS)
时间窗: 6 months after procedure
The Tegner Activity Scale (TAS) aims to provide a standardized method in determining the level of activity prior to injury and level of activity post injury that can be documented on a numerical scale. The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.
Visual Analogue Score (VAS)
时间窗: 6 months after procedure
In this method, the examined person marks a point on a line with a length of (for example) 10 cm, where the value 0 is assigned to the complete absence of pain, and the value 10 to the strongest pain imaginable.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: 6 months after procedure
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is defined as a disease-specific instrument used for assessing quality of life, particularly focusing on activity limitation in individuals with osteoarthritis. The WOMAC consists of three subscales and has a total possible score range of 0 to 96: pain (five questions), stiffness (two questions), and physical function (17 questions). The subscale scores can vary, with pain ranging from 0 to 20 points; stiffness, 0 to 8 points; and physical function, 0 to 68 points. Lower scores indicate better health status (less pain, stiffness, and functional limitations), while higher scores represent worse outcomes ( worse pain, stiffness, and functional limitations).
Biomechanical examination
时间窗: 6 months after procedure
On the Biodex 3 System measuring device
IKDC SUBJECTIVE KNEE EVALUATION FORM
时间窗: 6 months after procedure
Interpreted as a measure of function, such that higher scores represent higher levels of function and lower levels of symptoms. A score of 100 is interpreted to mean no limitation with sporting activities or daily living and the complete absence of symptoms.
Magnetic resonance imaging (MRI) of the knee joint
时间窗: 6 months after procedure
MRI (1.5 Tesli) will be used to assess the cartilage healing process following arthroscopic surgery. Radiological assessment will include cartilage defect fill, tissue integration, surface smoothness, and signal intensity of repair tissue. An imaging appearance indicative of effective healing is interpreted as a better outcome.
Ultrasound examination (USG) of the knee joint
时间窗: 6 months after procedure
Ultrasound examination on the apparatus with the option of elastometry will be used to assess postoperative tissue regeneration and intra-articular conditions. USG will be performed using a linear transducer with a frequency of 7-10 MHz. The evaluation will include: cartilage surface regularity and thickness, presence or absence of joint effusion, synovial membrane hypertrophy (synovitis), swelling or inflammatory changes in Hoffa's fat pad, signs of active inflammation. An imaging appearance indicative of effective healing is interpreted as a better outcome.
次要结局
未报告次要终点