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

NCT ID: NCT07110402

Last Updated: 2025-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-12

Study Completion Date

2024-12-12

Brief Summary

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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

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Autogenous transplant of fragmented adipose tissue taken from abdominal integuments

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.

Group Type EXPERIMENTAL

Autogenous transplant of fragmented adipose tissue taken from abdominal integuments

Intervention Type 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.

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).

Group Type EXPERIMENTAL

PRP GF (platelet-rich plasma with growth factors)

Intervention Type 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)

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

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

Group Type EXPERIMENTAL

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

Intervention Type 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

Hyaluronic acid - low molecular weight

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

Group Type EXPERIMENTAL

Hyaluronic acid - low molecular weight

Intervention Type PROCEDURE

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

Hyaluronic acid - cross-linked

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.

Group Type EXPERIMENTAL

Hyaluronic acid - cross-linked

Intervention Type 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

Interventions

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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.

Intervention Type 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)

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wroclaw Medical University

OTHER

Sponsor Role collaborator

eMKa MED Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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eMKa MED Medical Center

Wroclaw, Dolnośląsk, Poland

Site Status

Countries

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Poland

Other Identifiers

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KB-633/2022

Identifier Type: -

Identifier Source: org_study_id

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