Osteoarthritis, KneeNCT07110402
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
A study testing Autogenous transplant of fragmented adipose tissue taken from abdominal integuments, PRP GF (platelet-rich plasma with growth factors) and Mesenchymal cells centrifuged from bone marrow cells taken from the iliac crest in people with Osteoarthritis, Knee and Chondral Defect, run by eMKa MED Medical Center at 1 site in Poland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Osteoarthritis, Knee, Chondral Defect, Chondromalacia, Left Knee
- What is being tested?
- Autogenous transplant of fragmented adipose tissue taken from abdominal integuments, PRP GF (platelet-rich plasma with growth factors) and Mesenchymal cells centrifuged from bone marrow cells taken from the iliac crest
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePoland
- Study dates
- 12 Dec 2022to 12 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed 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.
- Conditions
- Osteoarthritis, Knee, Chondral Defect, Chondromalacia, Left Knee, Chondromalacia, Right Knee, Articular Cartilage Disorder of Knee
- Being tested
- 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
- Keywords
- Cartilage, Damage, Chondral defect, Chondromalacja, Techniques, Articular Cartilage Treated, Autogenous Transplant, PRP GF, Hyaluronic Acid, Mesenchymal Cells
- Medical subject headings
- Osteoarthritis, Knee, Cartilage Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autogenous transplant of fragmented adipose tissue taken from abdominal integumentsProcedure or surgery
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.
PRP GF (platelet-rich plasma with growth factors)Procedure or surgery
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)
Mesenchymal cells centrifuged from bone marrow cells taken from the iliac crestProcedure or surgery
Treatment of cartilage chondromalacia in the knee joint by arthroscopic technique using mesenchymal cells centrifuged from bone marrow cells taken from the iliac crest
Hyaluronic acid - low molecular weightProcedure or surgery
Treatment of chondromalacia of the cartilage in the knee joint with the use of Hyaluronic Acid - low molecular weight
Hyaluronic acid - cross-linkedProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: 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), Receives: 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). Receives: 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. Receives: Procedure: Hyaluronic acid - cross-linked |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months after procedure
Biomechanical examination
On the Biodex 3 System measuring device
Measured: 3 months after procedure
Biomechanical examination
On the Biodex 3 System measuring device
Measured: 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.
Measured: 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.
Measured: 6 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start12 Dec 2022
- Primary completion12 Dec 2024
- Study completion12 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- eMKa MED Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Wroclaw Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07110402
- Sponsor's protocol ID
- KB-633/2022
- Status last verified
- Jul 2025
- First submitted
- 23 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07110402
- Acronym / sponsor ID
- KB-633/2022
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- eMKa MED Medical CenterUniversity, hospital or other
- Collaborators
- Wroclaw Medical University
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 12 Dec 2024 (actual)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Autogenous transplant of fragmented adipose tissue taken from abdominal integuments | Experimental | Procedure: Autogenous transplant of fragmented adipose tissue taken from abdominal integumentsTreatment 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. |
| PRP GF (platelet-rich plasma with growth factors) | Experimental | Procedure: PRP GF (platelet-rich plasma with growth factors)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). |
| Mesenchymal cells centrifuged from bone marrow cells taken from the iliac crest | Experimental | Procedure: Mesenchymal cells centrifuged from bone marrow cells taken from the iliac crestTreatment of cartilage chondromalacia in the knee joint using mesenchymal cells centrifuged from bone marrow cells taken from the iliac crest - (Harvest, Arthrex), |
| Hyaluronic acid - low molecular weight | Experimental | Procedure: Hyaluronic acid - low molecular weightTreatment of chondromalacia of the cartilage in the knee joint with the use of Hyaluronic Acid - low molecular weight (Synvisc, Biolevox, ArtiAidPlus). |
| Hyaluronic acid - cross-linked | Experimental | Procedure: Hyaluronic acid - cross-linkedTreatment 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autogenous transplant of fragmented adipose tissue taken from abdominal integumentsTreatment 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. | Procedure or surgery | Autogenous transplant of fragmented adipose tissue taken from abdominal integuments |
| PRP GF (platelet-rich plasma with growth factors)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) | Procedure or surgery | PRP GF (platelet-rich plasma with growth factors) |
| Mesenchymal cells centrifuged from bone marrow cells taken from the iliac crestTreatment of cartilage chondromalacia in the knee joint by arthroscopic technique using mesenchymal cells centrifuged from bone marrow cells taken from the iliac crest | Procedure or surgery | Mesenchymal cells centrifuged from bone marrow cells taken from the iliac crest |
| Hyaluronic acid - low molecular weightTreatment of chondromalacia of the cartilage in the knee joint with the use of Hyaluronic Acid - low molecular weight | Procedure or surgery | Hyaluronic acid - low molecular weight |
| Hyaluronic acid - cross-linkedTreatment 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 | Procedure or surgery | Hyaluronic acid - cross-linked |
Primary outcome
Tegner Activity Level Scale (TAS)
Time frame: 1 day
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.
Tegner Activity Level Scale (TAS)
Time frame: 3 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.
Tegner Activity Level Scale (TAS)
Time frame: 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)
Time frame: 1 day
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.
Visual Analogue Score (VAS)
Time frame: 3 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.
Visual Analogue Score (VAS)
Time frame: 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)
Time frame: 1 day
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).
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 3 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).
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 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).
IKDC SUBJECTIVE KNEE EVALUATION FORM
Time frame: 1 day
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.
IKDC SUBJECTIVE KNEE EVALUATION FORM
Time frame: 3 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.
IKDC SUBJECTIVE KNEE EVALUATION FORM
Time frame: 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.
Biomechanical examination
Time frame: 3 months after procedure
On the Biodex 3 System measuring device
Biomechanical examination
Time frame: 6 months after procedure
On the Biodex 3 System measuring device
Magnetic resonance imaging (MRI) of the knee joint
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autogenous transplant of fragmented adipose tissue taken from abdominal integuments, PRP GF (platelet-rich plasma with growth factors) and Mesenchymal cells centrifuged from bone marrow cells taken from the iliac crest in people with Osteoarthritis, Knee and Chondral Defect, run by eMKa MED Medical Center at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tegner Activity Level Scale (TAS) (time frame: 1 day). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.