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Clinical and Comparative Evaluation of the Treatment Results of Arthroscopic Reconstruction of Cartilage Defects in the Knee Joint With the Use of Autogenous Cartilage Graft With PRP GF (Platelet-rich Plasma With Growth Factors)

Clinical and Comparative Evaluation of the Treatment Results of Arthroscopic Reconstruction of Cartilage Defects in the Knee Joint With the Use of Autogenous Cartilage Graft With PRP GF (Platelet-rich Plasma With Growth Factors).

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05328674
Enrollment
60
Registered
2022-04-14
Start date
2021-06-22
Completion date
2022-06-22
Last updated
2022-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cartilage Damage, Cartilage Injury, Knee Injuries

Keywords

Cartilage, Injury, Damage, Defects, Techniques, Reconstruction

Brief summary

Clinical and comparative evaluation of the treatment results of arthroscopic reconstruction of cartilage defects in the knee joint with the use of autogenous cartilage graft with PRP GF (platelet-rich plasma with growth factors)

Detailed description

The main goal of the research project is to evaluate the results of the treatment of arthroscopic reconstruction of cartilage defects in the knee joint with the use of an autogenous PRP GF cartilage graft. The specific objectives are: to compare the results of treatment of analogous areas of the cartilage defects of the knee joint obtained in the study groups using two methods: microfracture and autogenous PRP GF cartilage graft (Auto Cart-Arthrex method). The results on the operated limb will be compared in both groups both between the groups and with the results of clinical and biomechanical tests on non-operated limbs.

Interventions

PROCEDUREArthroscopic reconstruction of cartilage defects in the knee joint with the use of autogenous cartilage transplant with PRP GF (platelet plasma with growth factor)

Arthroscopic reconstruction of cartilage defects in the knee joint using an autogenous PRP GF cartilage transplant.

PROCEDUREArthroscopic reconstruction of the cartilage defects of the knee joint using the microfracture method

Arthroscopic reconstruction of the cartilage defects of the knee joint using the microfracture method.

Sponsors

Wroclaw Medical University
CollaboratorOTHER
eMKa MED Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

comparison of the results of arthroscopic treatment of analogous areas of cartilage defects in the knee joint obtained in study groups using two methods: microfracture and autogenous PRP GF cartilage graft (Auto Cart - Arthrex method).

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Age 18-65 years; * 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

* Age under 18 or over 65; * 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.

Design outcomes

Primary

MeasureTime frameDescription
Tegner Activity Level Scale (TAS)3 months after procedureThe 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 Lysholm Knee Scoring Scale1 dayThe Tegner Lyshom Knee Scoring Scale is a patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability). Grading the Tegner Lysholm Knee Scoring Scale: * \<65 - poor; * 65-83 - fair; * 84-90 - good; * \>90 - excellent.
Ultrasonography (USG)6 months after procedureUltrasound examination on the apparatus with the option of elastometry
IKDC SUBJECTIVE KNEE EVALUATION FORM1 dayInterpreted 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 examination3 months after procedureOn the Biodex 3 System measuring device
Body Mass Index (BMI)1 dayBMI is interpreted using standard weight status categories: I : below 18.5 kg/m2 - underweight; II : 18.5 - 24.9 kg/m2 - healthy weight; III : 25.0 - 29.9 kg/m2 - overweight; IV : 30.0 kg/m2 and above - obesity.
Magnetic resonance imaging (MRI)6 months after procedure1,5 Tesli
Visual Analogue Score1 dayVisual Analogue Score - subjective measure for acute and chronic pain. 100-mm VAS ratings of: * 0 to 4 mm can be considered no pain; * 5 to 44 mm, mild pain; * 45 to 74 mm, moderate pain; * 75 to 100 mm, severe pain.

Countries

Poland

Contacts

Primary ContactMaciej Kentel, MD PhD
emkamed.cm@gmail.com+48518744908
Backup ContactKacper Kentel, Master's degree
kacper.kentel@emkamed.com.pl+48695263711

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026