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)
- Conditions
- Knee InjuriesCartilage DamageCartilage Injury
- Interventions
- Procedure: Arthroscopic reconstruction of cartilage defects in the knee joint with the use of autogenous cartilage transplant with PRP GF (platelet plasma with growth factor)Procedure: Arthroscopic reconstruction of the cartilage defects of the knee joint using the microfracture method
- Registration Number
- NCT05328674
- Lead Sponsor
- eMKa MED Medical Center
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Method of autogenous PRP (Auto Cart-Arthrex) cartilage transplant Arthroscopic reconstruction of cartilage defects in the knee joint with the use of autogenous cartilage transplant with PRP GF (platelet plasma with growth factor) - Microfracture method Arthroscopic reconstruction of the cartilage defects of the knee joint using the microfracture method -
- Primary Outcome Measures
Name Time Method Ultrasonography (USG) 6 months after procedure Ultrasound examination on the apparatus with the option of elastometry
Visual Analogue Score 6 months after procedure Visual 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.Biomechanical examination 6 months after procedure On the Biodex 3 System measuring device
Body Mass Index (BMI) 6 months after procedure BMI 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 procedure 1,5 Tesli
Tegner Activity Level Scale (TAS) 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.Tegner Lysholm Knee Scoring Scale 6 months after procedure The 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.IKDC SUBJECTIVE KNEE EVALUATION FORM 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
eMKa MED Medical Center
🇵🇱Wrocław, Dolnośląsk, Poland