Cartilage DamageNCT05328674
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)
A study testing Arthroscopic reconstruction of cartilage defects in the knee joint with the use of autogenous cartilage transplant with PRP GF (platelet plasma with growth factor) and Arthroscopic reconstruction of the cartilage defects of the knee joint using the microfracture method in people with Cartilage Damage and Cartilage Injury, run by eMKa MED Medical Center at 1 site in Poland.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cartilage Damage, Cartilage Injury, Knee Injuries
- What is being tested?
- Arthroscopic reconstruction of cartilage defects in the knee joint with the use of autogenous cartilage transplant with PRP GF (platelet plasma with growth factor) and Arthroscopic reconstruction of the cartilage defects of the knee joint using the microfracture method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 22 Jun 2021to 22 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
eMKa MED Medical Center
Wroclaw, Dolnośląsk, 53-110
Maciej Kentel, MD, +48518744908, emkamed.cm@gmail.com
Kacper Kentel, master's degree, +48695263711, kacper.kentel@emkamed.com.pl
About this study
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).
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)
Read the 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.
- Conditions
- Cartilage Damage, Cartilage Injury, Knee Injuries
- Being tested
- 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
- Keywords
- Cartilage, Injury, Damage, Defects, Techniques, Reconstruction
- Medical subject headings
- Knee Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic reconstruction of cartilage defects in the knee joint with the use of autogenous cartilage transplant with PRP GF (platelet plasma with growth factor)Procedure or surgery
Arthroscopic reconstruction of cartilage defects in the knee joint using an autogenous PRP GF cartilage transplant.
Arthroscopic reconstruction of the cartilage defects of the knee joint using the microfracture methodProcedure or surgery
Arthroscopic reconstruction of the cartilage defects of the knee joint using the microfracture method.
| Study group | Role | What they receive |
|---|---|---|
| Microfracture method | Active comparator | Not described Receives: Procedure: Arthroscopic reconstruction of the cartilage defects of the knee joint using the microfracture method |
| Method of autogenous PRP (Auto Cart-Arthrex) cartilage transplant | Experimental | Not described Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months after procedure
Magnetic resonance imaging (MRI)
1,5 Tesli
Measured: 6 months after procedure
Ultrasonography (USG)
Ultrasound examination on the apparatus with the option of elastometry
Measured: 6 months after procedure
Biomechanical examination
On the Biodex 3 System measuring device
Measured: 3 months after procedure
Biomechanical examination
On the Biodex 3 System measuring device
Measured: 6 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start22 Jun 2021
- Primary completion22 Jun 2022 (estimated)
- Study completion22 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cartilage DamageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- eMKa MED Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Wroclaw Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328674
- Sponsor's protocol ID
- KB-563/2021
- Status last verified
- Mar 2022
- First submitted
- 30 Mar 2022
- Last updated
- 14 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT05328674
- Acronym / sponsor ID
- KB-563/2021
- Conditions
- Cartilage Damage, Cartilage Injury, Knee Injuries
- Keywords
- Cartilage, Injury, Damage, Defects, Techniques, Reconstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- eMKa MED Medical CenterUniversity, hospital or other
- Collaborators
- Wroclaw Medical University
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 22 Jun 2022 (estimated)
- Study completion
- 22 Jun 2022 (estimated)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Microfracture method | Active comparator | Procedure: Arthroscopic reconstruction of the cartilage defects of the knee joint using the microfracture method |
| Method of autogenous PRP (Auto Cart-Arthrex) cartilage transplant | Experimental | 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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Method of autogenous PRP (Auto Cart-Arthrex) cartilage transplant |
| Arthroscopic reconstruction of the cartilage defects of the knee joint using the microfracture methodArthroscopic reconstruction of the cartilage defects of the knee joint using the microfracture method. | Procedure or surgery | Microfracture method |
Primary outcome
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.
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.
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.
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.
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.
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: 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.
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.
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: 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.
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.
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.
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.
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.
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
Ultrasonography (USG)
Time frame: 6 months after procedure
Ultrasound examination on the apparatus with the option of elastometry
Biomechanical examination
Time frame: 3 months after procedure
On the Biodex 3 System measuring device
Biomechanical examination
Time frame: 6 months after procedure
On the Biodex 3 System measuring device
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic reconstruction of cartilage defects in the knee joint with the use of autogenous cartilage transplant with PRP GF (platelet plasma with growth factor) and Arthroscopic reconstruction of the cartilage defects of the knee joint using the microfracture method in people with Cartilage Damage and Cartilage Injury, run by eMKa MED Medical Center at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maciej Kentel, MD PhD (+48518744908, emkamed.cm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Score (time frame: 1 day). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.