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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)

Primary Purpose

Cartilage Damage, Cartilage Injury, Knee Injuries

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
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 the cartilage defects of the knee joint using the microfracture method
Sponsored by
eMKa MED Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cartilage Damage focused on measuring Cartilage, Injury, Damage, Defects, Techniques, Reconstruction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • eMKa MED Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Microfracture method

Method of autogenous PRP (Auto Cart-Arthrex) cartilage transplant

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Magnetic resonance imaging (MRI)
1,5 Tesli
Ultrasonography (USG)
Ultrasound examination on the apparatus with the option of elastometry
Biomechanical examination
On the Biodex 3 System measuring device
Biomechanical examination
On the Biodex 3 System measuring device

Secondary Outcome Measures

Full Information

First Posted
March 30, 2022
Last Updated
April 7, 2022
Sponsor
eMKa MED Medical Center
Collaborators
Wroclaw Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05328674
Brief 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)
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 22, 2021 (Actual)
Primary Completion Date
June 22, 2022 (Anticipated)
Study Completion Date
June 22, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
eMKa MED Medical Center
Collaborators
Wroclaw Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cartilage Damage, Cartilage Injury, Knee Injuries
Keywords
Cartilage, Injury, Damage, Defects, Techniques, Reconstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Microfracture method
Arm Type
Active Comparator
Arm Title
Method of autogenous PRP (Auto Cart-Arthrex) cartilage transplant
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic reconstruction of cartilage defects in the knee joint with the use of autogenous cartilage transplant with PRP GF (platelet plasma with growth factor)
Intervention Description
Arthroscopic reconstruction of cartilage defects in the knee joint using an autogenous PRP GF cartilage transplant.
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic reconstruction of the cartilage defects of the knee joint using the microfracture method
Intervention Description
Arthroscopic reconstruction of the cartilage defects of the knee joint using the microfracture method.
Primary Outcome Measure Information:
Title
Visual Analogue Score
Description
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.
Time Frame
1 day
Title
Visual Analogue Score
Description
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.
Time Frame
3 months after procedure
Title
Visual Analogue Score
Description
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.
Time Frame
6 months after procedure
Title
Tegner Activity Level Scale (TAS)
Description
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.
Time Frame
1 day
Title
Tegner Activity Level Scale (TAS)
Description
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.
Time Frame
3 months after procedure
Title
Tegner Activity Level Scale (TAS)
Description
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.
Time Frame
6 months after procedure
Title
Tegner Lysholm Knee Scoring Scale
Description
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.
Time Frame
1 day
Title
Tegner Lysholm Knee Scoring Scale
Description
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.
Time Frame
3 months after procedure
Title
Tegner Lysholm Knee Scoring Scale
Description
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.
Time Frame
6 months after procedure
Title
IKDC SUBJECTIVE KNEE EVALUATION FORM
Description
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.
Time Frame
1 day
Title
IKDC SUBJECTIVE KNEE EVALUATION FORM
Description
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.
Time Frame
3 months after procedure
Title
IKDC SUBJECTIVE KNEE EVALUATION FORM
Description
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.
Time Frame
6 months after procedure
Title
Body Mass Index (BMI)
Description
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.
Time Frame
1 day
Title
Body Mass Index (BMI)
Description
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.
Time Frame
3 months after procedure
Title
Body Mass Index (BMI)
Description
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.
Time Frame
6 months after procedure
Title
Magnetic resonance imaging (MRI)
Description
1,5 Tesli
Time Frame
6 months after procedure
Title
Ultrasonography (USG)
Description
Ultrasound examination on the apparatus with the option of elastometry
Time Frame
6 months after procedure
Title
Biomechanical examination
Description
On the Biodex 3 System measuring device
Time Frame
3 months after procedure
Title
Biomechanical examination
Description
On the Biodex 3 System measuring device
Time Frame
6 months after procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maciej Kentel, MD PhD
Phone
+48518744908
Email
emkamed.cm@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kacper Kentel, Master's degree
Phone
+48695263711
Email
kacper.kentel@emkamed.com.pl
Facility Information:
Facility Name
eMKa MED Medical Center
City
Wrocław
State/Province
Dolnośląsk
ZIP/Postal Code
53-110
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maciej Kentel, MD
Phone
+48518744908
Email
emkamed.cm@gmail.com
First Name & Middle Initial & Last Name & Degree
Kacper Kentel, master's degree
Phone
+48695263711
Email
kacper.kentel@emkamed.com.pl

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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)

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