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

NCT07110402 | Completed

• 1 other identifier: KB-633/2022
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Cartilage; Damage; Chondral defect; Chondromalacja; Techniques; Articular Cartilage Treated; Autogenous Transplant; PRP GF; Hyaluronic Acid; Mesenchymal Cells

Outcome Measures

Primary Outcomes (16)

• Tegner Activity Level Scale (TAS)

  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.

  1 day

• Tegner Activity Level Scale (TAS)

  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.

  3 months after procedure

• Tegner Activity Level Scale (TAS)

  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.

  6 months after procedure

• Visual Analogue Score (VAS)

  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.

  1 day

• Visual Analogue Score (VAS)

  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.

  3 months after procedure

• Visual Analogue Score (VAS)

  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.

  6 months after procedure

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  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).

  1 day

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  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).

  3 months after procedure

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  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).

  6 months after procedure

• IKDC SUBJECTIVE KNEE EVALUATION FORM

  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.

  1 day

• IKDC SUBJECTIVE KNEE EVALUATION FORM

  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.

  3 months after procedure

• IKDC SUBJECTIVE KNEE EVALUATION FORM

  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.

  6 months after procedure

• Biomechanical examination

  On the Biodex 3 System measuring device

  3 months after procedure

• Biomechanical examination

  On the Biodex 3 System measuring device

  6 months after procedure

• Magnetic resonance imaging (MRI) of the knee joint

  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.

  6 months after procedure

• Ultrasound examination (USG) of the knee joint

  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.

  6 months after procedure

Study Arms (5)

Autogenous transplant of fragmented adipose tissue taken from abdominal integuments

EXPERIMENTAL

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.

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

PRP GF (platelet-rich plasma with growth factors)

EXPERIMENTAL

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).

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

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

EXPERIMENTAL

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

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

Hyaluronic acid - low molecular weight

EXPERIMENTAL

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

Procedure: Hyaluronic acid - low molecular weight

Hyaluronic acid - cross-linked

EXPERIMENTAL

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.

Procedure: Hyaluronic acid - cross-linked

Interventions

Autogenous transplant of fragmented adipose tissue taken from abdominal integuments PROCEDURE

Treatment of chondromalacia of the cartilage in the knee joint by arthroscopic technique with the use of autogenous graft of fragmented adipose tissue taken from the abdominal wall.

Autogenous transplant of fragmented adipose tissue taken from abdominal integuments

PRP GF (platelet-rich plasma with growth factors) PROCEDURE

Treatment of chondromalacia of the cartilage in the knee joint by arthroscopic technique with the use of PRP GF (platelet-rich plasma with growth factors)

PRP GF (platelet-rich plasma with growth factors)

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

Treatment of cartilage chondromalacia in the knee joint by arthroscopic technique using mesenchymal cells centrifuged from bone marrow cells taken from the iliac crest

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

Hyaluronic acid - low molecular weight PROCEDURE

Treatment of chondromalacia of the cartilage in the knee joint with the use of Hyaluronic Acid - low molecular weight

Hyaluronic acid - low molecular weight

Hyaluronic acid - cross-linked PROCEDURE

Treatment of chondromalacia of the cartilage in the knee joint by arthroscopic technique with the use of cross-linked Hyaluronic Acid Arti Aid Plus, Synovial, Durolain, StavOn, Collagenu

Hyaluronic acid - cross-linked

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• eMKa MED Medical Center: lead
• Wroclaw Medical University: collaborator

Study Sites (1)

eMKa MED Medical Center

Wroclaw, Dolnośląsk, 53-110, Poland

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Cartilage Diseases

Interventions

Intercellular Signaling Peptides and Proteins

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1. Autogenous transplant of fragmented adipose tissue taken from abdominal integuments - (MyStem, Lipogems, Arthrex) 2. PRP GF (platelet-rich plasma with growth factors) (Ycellbio, ACP Arthrex, Neoregen, FrankPharma) 3. Mesenchymal cells centrifuged from bone marrow cells taken from the iliac crest - (Harvest, Arthrex) 4. Hyaluronic acid - low molecular weight (Synvisc, Biolevox, ArtiAidPlus) 5. Hyaluronic acid - cross-linked Arti Aid Plus, Synovial, Durolain, StavOn, Collagenu - Guna, Orthokine.

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: August 7, 2025
• Study Start: December 12, 2022
• Primary Completion: December 12, 2024
• Study Completion: December 12, 2024
• Last Updated: August 7, 2025

Record last verified: 2025-07

Locations

PL (1)