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)

April 7, 2022 updated by: eMKa MED Medical Center

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Analogue Score
Time Frame: 1 day

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
Time Frame: 3 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.
3 months after procedure
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.
6 months after procedure
Tegner Activity Level Scale (TAS)
Time Frame: 1 day

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)
Time Frame: 3 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.
3 months after procedure
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.
6 months after procedure
Tegner Lysholm Knee Scoring Scale
Time Frame: 1 day

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
Time Frame: 3 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.
3 months after procedure
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.
6 months after procedure
IKDC SUBJECTIVE KNEE EVALUATION FORM
Time Frame: 1 day
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
Time Frame: 3 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.
3 months after procedure
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.
6 months after procedure
Body Mass Index (BMI)
Time Frame: 1 day

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)
Time Frame: 3 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.
3 months after procedure
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.
6 months after procedure
Magnetic resonance imaging (MRI)
Time Frame: 6 months after procedure
1,5 Tesli
6 months after procedure
Ultrasonography (USG)
Time Frame: 6 months after procedure
Ultrasound examination on the apparatus with the option of elastometry
6 months after procedure
Biomechanical examination
Time Frame: 3 months after procedure
On the Biodex 3 System measuring device
3 months after procedure
Biomechanical examination
Time Frame: 6 months after procedure
On the Biodex 3 System measuring device
6 months after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
eMKa MED Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Wroclaw Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 22, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 22, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 22, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Knee Injuries

Clinical Trials on Arthroscopic reconstruction of the cartilage defects of the knee joint using the microfracture method

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings