Evaluation of Treatment of Osteoarthritis of the Knee in the Form of Chondromalacia of the Articular Cartilage Treated in the Arthroscopic Technique With the Use of:Autogenous Transplantation of Fragmented Adipose Tissue,PRP GF,Mesenchymal Cells,Hyaluronic Acid-low Molecular Weight and Cross-linked

eMKa MED Medical Center

Status: Completed

Conditions: Chondromalacia, Left Knee; Chondral Defect; Chondromalacia, Right Knee; Articular Cartilage Disorder of Knee; Osteoarthritis, Knee

Treatments: Procedure: Autogenous transplant of fragmented adipose tissue taken from abdominal integuments; Procedure: Hyaluronic acid - cross-linked; Procedure: PRP GF (platelet-rich plasma with growth factors); Procedure: Hyaluronic acid - low molecular weight; Procedure: Mesenchymal cells centrifuged from bone marrow cells taken from the iliac crest

Study type: Interventional

Funder types: Other

Identifiers

NCT07110402

KB-633/2022

Details and patient eligibility

About

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.

Full description

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.

Measurements of the range of motion of the knee joint, measurements of the circumference of the knee joint and thigh, measurements of the torques of the extensor and flexor muscles of the knee joint as well as the muscles responsible for the internal and external rotation of the lower leg relative to the thigh in the knee joint in static and isokinetic conditions, measurements of proprioception on the Biodex 4 measuring stand System, measurements of gait kinetics and kinematics using the BTS Smart optoelectronic system for three-dimensional movement analysis and two Kistler strain gauge platforms, as well as the squat test.

Enrollment: 150 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 5 patient groups

Autogenous transplant of fragmented adipose tissue taken from abdominal integuments

Experimental group

Description:

Treatment of chondromalacia of the cartilage in the knee joint with the use of autogenous graft of fragmented adipose tissue taken from the abdominal wall - MyStem, Lipogems, Arthrex.

Treatment:

Procedure: Autogenous transplant of fragmented adipose tissue taken from abdominal integuments

PRP GF (platelet-rich plasma with growth factors)

Experimental group

Description:

Treatment of chondromalacia of the cartilage in the knee joint with the use of PRP GF (platelet-rich plasma with growth factors: Ycellbio, ACP Arthrex, Neoregen, PhankPharma).

Treatment:

Procedure: PRP GF (platelet-rich plasma with growth factors)

Mesenchymal cells centrifuged from bone marrow cells taken from the iliac crest

Experimental group

Description:

Treatment of cartilage chondromalacia in the knee joint using mesenchymal cells centrifuged from bone marrow cells taken from the iliac crest - (Harvest, Arthrex),

Treatment:

Procedure: Mesenchymal cells centrifuged from bone marrow cells taken from the iliac crest

Hyaluronic acid - low molecular weight

Experimental group

Description:

Treatment of chondromalacia of the cartilage in the knee joint with the use of Hyaluronic Acid - low molecular weight (Synvisc, Biolevox, ArtiAidPlus).

Treatment:

Procedure: Hyaluronic acid - low molecular weight

Hyaluronic acid - cross-linked

Experimental group

Description:

Treatment of chondromalacia of the cartilage in the knee joint with the use of cross-linked Hyaluronic Acid Arti Aid Plus, Synovial, Durolain, StavOn, Collagenu - Guna, Orthokine.

Treatment:

Procedure: Hyaluronic acid - cross-linked