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)

NCT ID: NCT05328674

Last Updated: 2022-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-22

Study Completion Date

2022-06-22

Brief Summary

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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)

Detailed Description

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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

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Cartilage Damage Cartilage Injury Knee Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Microfracture method

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

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

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

Group Type EXPERIMENTAL

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 Type PROCEDURE

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

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wroclaw Medical University

OTHER

Sponsor Role collaborator

eMKa MED Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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eMKa MED Medical Center

Wroclaw, Dolnośląsk, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Maciej Kentel, MD PhD

Role: CONTACT

+48518744908

Kacper Kentel, Master's degree

Role: CONTACT

+48695263711

Facility Contacts

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Maciej Kentel, MD

Role: primary

+48518744908

Kacper Kentel, master's degree

Role: backup

+48695263711

Other Identifiers

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KB-563/2021

Identifier Type: -

Identifier Source: org_study_id

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