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Clinical Trials/NCT05328674
NCT05328674
Unknown
Not Applicable

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).

eMKa MED Medical Center1 site in 1 country60 target enrollmentJune 22, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cartilage Damage
Sponsor
eMKa MED Medical Center
Enrollment
60
Locations
1
Primary Endpoint
Ultrasonography (USG)
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 22, 2021
End Date
June 22, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
eMKa MED Medical Center
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Ultrasonography (USG)

Time Frame: 6 months after procedure

Ultrasound examination on the apparatus with the option of elastometry

Visual Analogue Score

Time Frame: 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

Time Frame: 6 months after procedure

On the Biodex 3 System measuring device

Body Mass Index (BMI)

Time Frame: 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)

Time Frame: 6 months after procedure

1,5 Tesli

Tegner Activity Level Scale (TAS)

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Study Sites (1)

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