Trials / Completed
CompletedNCT07110402
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
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 150 (actual)
- Sponsor
- eMKa MED Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Autogenous transplant of fragmented adipose tissue taken from abdominal integuments | 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. |
| PROCEDURE | 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 | Mesenchymal cells centrifuged from bone marrow cells taken from the iliac crest | Treatment of cartilage chondromalacia in the knee joint by arthroscopic technique using mesenchymal cells centrifuged from bone marrow cells taken from the iliac crest |
| PROCEDURE | Hyaluronic acid - low molecular weight | Treatment of chondromalacia of the cartilage in the knee joint with the use of Hyaluronic Acid - low molecular weight |
| PROCEDURE | Hyaluronic acid - cross-linked | 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 |
Timeline
- Start date
- 2022-12-12
- Primary completion
- 2024-12-12
- Completion
- 2024-12-12
- First posted
- 2025-08-07
- Last updated
- 2025-08-07
Locations
1 site across 1 country: Poland
Source: ClinicalTrials.gov record NCT07110402. Inclusion in this directory is not an endorsement.