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Comparison of the Results of Arthroscopic Suturing of the Medial Meniscus Using the Fast Fix and FiberStitch Systems

Primary Purpose

Meniscus; Detachment, Current Injury, Detachment, Medial Mensical Tear

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Medial Meniscus Arthroscopic Reconstruction Using the Fast Fix
Medial Meniscus Arthroscopic Reconstruction Using the Fiber Stitch
Sponsored by
eMKa MED Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meniscus; Detachment, Current Injury focused on measuring meniscus;, medial;, injury;, suture;, techniques;

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Isolated MM damage.
  • Operation performed only in arthroscopy technique.
  • No any knee intervention earlier.
  • No other pathology in the anatomical area.
  • Patient informed consent to participate in research

Exclusion Criteria:

  • Age under 18 years old or above 35 years old.
  • Any knee intervention performed earlier.
  • Any other pathology in the anatomical area identified during preoperative diagnostics.
  • Any damage in the area of the second knee joint.
  • Failure complying the same treatment protocol rigor.

Sites / Locations

  • eMKa MED Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Medial Meniscus Arthroscopic Reconstruction Using the Fast Fix

Medial Meniscus Arthroscopic Reconstruction Using the Fiber Stitch

Arm Description

Outcomes

Primary Outcome Measures

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 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.
Visual Analogue Score (VAS)
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 (VAS)
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 (VAS)
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 (VAS)
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.
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.
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.
Knee Society Score (KSS);
The Knee Society Score (KSS) evaluates the clinical picture in terms of pain intensity, range of motion and stability in the anteroposterior and mediolateral planes, flexion deformities, contractures and poor alignment, and is widely used in clinic and mentioned in orthopedic literature. Grading for the Knee Society Score: 80-100 - excellent; 70-79 - good; 60-60 - fair; below 60 - poor.
Knee Society Score (KSS);
The Knee Society Score (KSS) evaluates the clinical picture in terms of pain intensity, range of motion and stability in the anteroposterior and mediolateral planes, flexion deformities, contractures and poor alignment, and is widely used in clinic and mentioned in orthopedic literature. Grading for the Knee Society Score: 80-100 - excellent; 70-79 - good; 60-60 - fair; below 60 - poor.
Knee Society Score (KSS);
The Knee Society Score (KSS) evaluates the clinical picture in terms of pain intensity, range of motion and stability in the anteroposterior and mediolateral planes, flexion deformities, contractures and poor alignment, and is widely used in clinic and mentioned in orthopedic literature. Grading for the Knee Society Score: 80-100 - excellent; 70-79 - good; 60-60 - fair; below 60 - poor.
Knee Society Score (KSS);
The Knee Society Score (KSS) evaluates the clinical picture in terms of pain intensity, range of motion and stability in the anteroposterior and mediolateral planes, flexion deformities, contractures and poor alignment, and is widely used in clinic and mentioned in orthopedic literature. Grading for the Knee Society Score: 80-100 - excellent; 70-79 - good; 60-60 - fair; below 60 - poor.
Knee Injury and Osteoarthritis Outcome Score (KOOS);
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
Knee Injury and Osteoarthritis Outcome Score (KOOS);
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
Knee Injury and Osteoarthritis Outcome Score (KOOS);
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
Knee Injury and Osteoarthritis Outcome Score (KOOS);
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
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.
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.
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.
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.
Biomechanical examination
On the Biodex 3 System measuring device
Biomechanical examination
On the Biodex 3 System measuring device
Ultrasound examination (USG)
Ultrasound examination on the apparatus with the option of elastometry
Ultrasound examination (USG)
Ultrasound examination on the apparatus with the option of elastometry
Magnetic resonance imaging (MRI)
1,5 Tesli
Magnetic resonance imaging (MRI)
1,5 Tesli

Secondary Outcome Measures

Full Information

First Posted
March 22, 2021
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
NCT05318118
Brief Title
Comparison of the Results of Arthroscopic Suturing of the Medial Meniscus Using the Fast Fix and FiberStitch Systems
Official Title
Comparative of Clinical and Evaluation Results of Medial Meniscus Arthroscopic Reconstruction Using the Fast Fix and FiberStitch Systems
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2021 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 1, 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
Data Monitoring Committee
No

5. Study Description

Brief Summary
Clinical and comparative evaluation of the treatment results of arthroscopic reconstruction of the medial meniscus of the knee joint using the Fast Fix and FiberStitch systems.
Detailed Description
The main goal of the project is to evaluate the results of medial meniscus traumatic injury suturing. Further (detailed) objectives are: to compare the results obtained in the study groups of suturing the medial meniscus with the use of two systems: Fast Fix (smith & nephew) and Fiber Stitch (arthrex). The results refering to the operated limb will be compared in both groups between themselves and furthermore with the results of clinical and biomechanical studies on non-operated limbs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meniscus; Detachment, Current Injury, Detachment, Medial Mensical Tear, Medial Meniscus Knee Injury
Keywords
meniscus;, medial;, injury;, suture;, techniques;

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The results refering to the operated limb will be compared in both groups between themselves and furthermore with the results of clinical and biomechanical studies on non-operated limbs.
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Medial Meniscus Arthroscopic Reconstruction Using the Fast Fix
Arm Type
Active Comparator
Arm Title
Medial Meniscus Arthroscopic Reconstruction Using the Fiber Stitch
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Medial Meniscus Arthroscopic Reconstruction Using the Fast Fix
Intervention Description
Arthroscopic reconstruction of damaged Medial Meniscus using Fast-Fix (Smith & Nephew) implant.
Intervention Type
Procedure
Intervention Name(s)
Medial Meniscus Arthroscopic Reconstruction Using the Fiber Stitch
Intervention Description
Arthroscopic reconstruction of damaged Medial Meniscus using Fiber-Stitch (Arthrex) implant
Primary Outcome Measure Information:
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 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
12 months after procedure
Title
Visual Analogue Score (VAS)
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 (VAS)
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 (VAS)
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
Visual Analogue Score (VAS)
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
12 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
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
12 months after procedure
Title
Knee Society Score (KSS);
Description
The Knee Society Score (KSS) evaluates the clinical picture in terms of pain intensity, range of motion and stability in the anteroposterior and mediolateral planes, flexion deformities, contractures and poor alignment, and is widely used in clinic and mentioned in orthopedic literature. Grading for the Knee Society Score: 80-100 - excellent; 70-79 - good; 60-60 - fair; below 60 - poor.
Time Frame
1 day
Title
Knee Society Score (KSS);
Description
The Knee Society Score (KSS) evaluates the clinical picture in terms of pain intensity, range of motion and stability in the anteroposterior and mediolateral planes, flexion deformities, contractures and poor alignment, and is widely used in clinic and mentioned in orthopedic literature. Grading for the Knee Society Score: 80-100 - excellent; 70-79 - good; 60-60 - fair; below 60 - poor.
Time Frame
3 months after procedure
Title
Knee Society Score (KSS);
Description
The Knee Society Score (KSS) evaluates the clinical picture in terms of pain intensity, range of motion and stability in the anteroposterior and mediolateral planes, flexion deformities, contractures and poor alignment, and is widely used in clinic and mentioned in orthopedic literature. Grading for the Knee Society Score: 80-100 - excellent; 70-79 - good; 60-60 - fair; below 60 - poor.
Time Frame
6 months after procedure
Title
Knee Society Score (KSS);
Description
The Knee Society Score (KSS) evaluates the clinical picture in terms of pain intensity, range of motion and stability in the anteroposterior and mediolateral planes, flexion deformities, contractures and poor alignment, and is widely used in clinic and mentioned in orthopedic literature. Grading for the Knee Society Score: 80-100 - excellent; 70-79 - good; 60-60 - fair; below 60 - poor.
Time Frame
12 months after procedure
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS);
Description
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
Time Frame
1 day
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS);
Description
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
Time Frame
3 months after procedure
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS);
Description
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
Time Frame
6 months after procedure
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS);
Description
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
Time Frame
12 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
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
12 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
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
12 months after procedure
Title
Biomechanical examination
Description
On the Biodex 3 System measuring device
Time Frame
9 months after procedure
Title
Biomechanical examination
Description
On the Biodex 3 System measuring device
Time Frame
12 months after procedure
Title
Ultrasound examination (USG)
Description
Ultrasound examination on the apparatus with the option of elastometry
Time Frame
6 months after procedure
Title
Ultrasound examination (USG)
Description
Ultrasound examination on the apparatus with the option of elastometry
Time Frame
12 months after procedure
Title
Magnetic resonance imaging (MRI)
Description
1,5 Tesli
Time Frame
6 months after procedure
Title
Magnetic resonance imaging (MRI)
Description
1,5 Tesli
Time Frame
12 months after procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Isolated MM damage. Operation performed only in arthroscopy technique. No any knee intervention earlier. No other pathology in the anatomical area. Patient informed consent to participate in research Exclusion Criteria: Age under 18 years old or above 35 years old. Any knee intervention performed earlier. Any other pathology in the anatomical area identified during preoperative diagnostics. Any damage in the area of the second knee joint. Failure complying the same treatment protocol rigor.
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

Comparison of the Results of Arthroscopic Suturing of the Medial Meniscus Using the Fast Fix and FiberStitch Systems

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