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).

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 Overview

• Status: Recruiting
• Conditions: Knee Injuries; Cartilage Injury; Cartilage Damage
• Intervention / Treatment: Procedure: Arthroscopic reconstruction of the cartilage defects of the knee joint using the microfracture method; 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)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Dolnośląsk
    • Wrocław, Dolnośląsk, Poland, 53-110
      • Recruiting
      • eMKa MED Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Microfracture method	Procedure: Arthroscopic 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.
Experimental: Method of autogenous PRP (Auto Cart-Arthrex) cartilage transplant	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); Arthroscopic reconstruction of cartilage defects in the knee joint using an autogenous PRP GF cartilage transplant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Score	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.	1 day
Visual Analogue Score	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.	3 months after procedure
Visual Analogue Score	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.	6 months after procedure
Tegner Activity Level Scale (TAS)	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.	1 day
Tegner Activity Level Scale (TAS)	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.	3 months after procedure
Tegner Activity Level Scale (TAS)	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.	6 months after procedure
Tegner Lysholm Knee Scoring Scale	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.	1 day
Tegner Lysholm Knee Scoring Scale	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.	3 months after procedure
Tegner Lysholm Knee Scoring Scale	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.	6 months after procedure
IKDC SUBJECTIVE KNEE EVALUATION FORM	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.	1 day
IKDC SUBJECTIVE KNEE EVALUATION FORM	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.	3 months after procedure
IKDC SUBJECTIVE KNEE EVALUATION FORM	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.	6 months after procedure
Body Mass Index (BMI)	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.	1 day
Body Mass Index (BMI)	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.	3 months after procedure
Body Mass Index (BMI)	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.	6 months after procedure
Magnetic resonance imaging (MRI)	1,5 Tesli	6 months after procedure
Ultrasonography (USG)	Ultrasound examination on the apparatus with the option of elastometry	6 months after procedure
Biomechanical examination	On the Biodex 3 System measuring device	3 months after procedure
Biomechanical examination	On the Biodex 3 System measuring device	6 months after procedure

Collaborators and Investigators

• Sponsor: eMKa MED Medical Center
• Collaborators: Wroclaw Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2021
• Primary Completion (Anticipated): June 22, 2022
• Study Completion (Anticipated): June 22, 2022

Study Registration Dates

• First Submitted: March 30, 2022
• First Submitted That Met QC Criteria: April 7, 2022
• First Posted (Actual): April 14, 2022

Study Record Updates

• Last Update Posted (Actual): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Reconstruction; Cartilage; Injury; Techniques; Damage; Defects
• Additional Relevant MeSH Terms: Leg Injuries; Wounds and Injuries; Knee Injuries; Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Mitogens
• Other Study ID Numbers: KB-563/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No