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)

NCT05328674 | Unknown

• 1 other identifier: KB-563/2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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)

Conditions

Cartilage Damage; Cartilage Injury; Knee Injuries

Keywords

Cartilage; Injury; Damage; Defects; Techniques; Reconstruction

Outcome Measures

Primary Outcomes (19)

• 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

Study Arms (2)

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)

Interventions

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

Arthroscopic reconstruction of cartilage defects in the knee joint using an autogenous PRP GF cartilage transplant.

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

Arthroscopic reconstruction of the cartilage defects of the knee joint using the microfracture method PROCEDURE

Arthroscopic reconstruction of the cartilage defects of the knee joint using the microfracture method.

Microfracture method

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• eMKa MED Medical Center: lead
• Wroclaw Medical University: collaborator

Study Sites (1)

eMKa MED Medical Center

Wroclaw, Dolnośląsk, 53-110, Poland

RECRUITING

MeSH Terms

Conditions

Knee Injuries; Wounds and Injuries

Interventions

Intercellular Signaling Peptides and Proteins

Condition Hierarchy (Ancestors)

Leg Injuries

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Central Study Contacts

Maciej Kentel, MD PhD

CONTACT

+48518744908; emkamed.cm@gmail.com

Kacper Kentel, Master's degree

CONTACT

+48695263711; kacper.kentel@emkamed.com.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 14, 2022
• Study Start: June 22, 2021
• Primary Completion: June 22, 2022
• Study Completion: June 22, 2022
• Last Updated: April 14, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)