Clinical trial NCT05328674: 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)
Official title: 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).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cartilage Damage
Cartilage Injury
Knee Injuries
Keywords: Cartilage
Injury
Damage
Defects
Techniques
Reconstruction
Lead sponsor: eMKa MED Medical Center
Sponsor class: OTHER
Collaborators: name: Wroclaw Medical University
First posted: 2022-04-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analogue Score
timeFrame: 1 day
measure: Visual Analogue Score
timeFrame: 3 months after procedure
measure: Visual Analogue Score
timeFrame: 6 months after procedure
measure: Tegner Activity Level Scale (TAS)
timeFrame: 1 day
measure: Tegner Activity Level Scale (TAS)
timeFrame: 3 months after procedure
measure: Tegner Activity Level Scale (TAS)
timeFrame: 6 months after procedure
measure: Tegner Lysholm Knee Scoring Scale
timeFrame: 1 day
measure: Tegner Lysholm Knee Scoring Scale
timeFrame: 3 months after procedure
measure: Tegner Lysholm Knee Scoring Scale
timeFrame: 6 months after procedure
measure: IKDC SUBJECTIVE KNEE EVALUATION FORM
timeFrame: 1 day
measure: IKDC SUBJECTIVE KNEE EVALUATION FORM
timeFrame: 3 months after procedure
measure: IKDC SUBJECTIVE KNEE EVALUATION FORM
timeFrame: 6 months after procedure
measure: Body Mass Index (BMI)
timeFrame: 1 day
measure: Body Mass Index (BMI)
timeFrame: 3 months after procedure
measure: Body Mass Index (BMI)
timeFrame: 6 months after procedure
measure: Magnetic resonance imaging (MRI)
timeFrame: 6 months after procedure
measure: Ultrasonography (USG)
timeFrame: 6 months after procedure
measure: Biomechanical examination
timeFrame: 3 months after procedure
measure: Biomechanical examination
timeFrame: 6 months after procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Wrocław
country: Poland
facility: eMKa MED Medical Center
state: Dolnośląsk
Study officials:
References: