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

Comparative of Clinical and Evaluation Results of Medial Meniscus Arthroscopic Reconstruction Using the Fast Fix and FiberStitch Systems

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.

Study Overview

• Status: Recruiting
• Conditions: Meniscus; Detachment, Current Injury; Detachment; Medial Mensical Tear; Medial Meniscus Knee Injury
• Intervention / Treatment: Procedure: Medial Meniscus Arthroscopic Reconstruction Using the Fast Fix; Procedure: Medial Meniscus Arthroscopic Reconstruction Using the Fiber Stitch

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Medial Meniscus Arthroscopic Reconstruction Using the Fast Fix	Procedure: Medial Meniscus Arthroscopic Reconstruction Using the Fast Fix; Arthroscopic reconstruction of damaged Medial Meniscus using Fast-Fix (Smith & Nephew) implant.
ACTIVE_COMPARATOR: Medial Meniscus Arthroscopic Reconstruction Using the Fiber Stitch	Procedure: Medial Meniscus Arthroscopic Reconstruction Using the Fiber Stitch; Arthroscopic reconstruction of damaged Medial Meniscus using Fiber-Stitch (Arthrex) implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 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.	12 months after procedure
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.	1 day
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.	3 months after procedure
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.	6 months after procedure
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.	12 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.	12 months after procedure
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.	1 day
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.	3 months after procedure
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.	6 months after procedure
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.	12 months after procedure
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.	1 day
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.	3 months after procedure
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.	6 months after procedure
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.	12 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
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.	12 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.	12 months after procedure
Biomechanical examination	On the Biodex 3 System measuring device	9 months after procedure
Biomechanical examination	On the Biodex 3 System measuring device	12 months after procedure
Ultrasound examination (USG)	Ultrasound examination on the apparatus with the option of elastometry	6 months after procedure
Ultrasound examination (USG)	Ultrasound examination on the apparatus with the option of elastometry	12 months after procedure
Magnetic resonance imaging (MRI)	1,5 Tesli	12 months after procedure

Collaborators and Investigators

• Sponsor: eMKa MED Medical Center
• Collaborators: Wroclaw Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 8, 2021
• Primary Completion (ANTICIPATED): September 1, 2022
• Study Completion (ANTICIPATED): September 1, 2022

Study Registration Dates

• First Submitted: March 22, 2021
• First Submitted That Met QC Criteria: April 7, 2022
• First Posted (ACTUAL): April 8, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 8, 2022
• Last Update Submitted That Met QC Criteria: April 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: meniscus;; medial;; injury;; suture;; techniques
• Additional Relevant MeSH Terms: Mental Disorders; Leg Injuries; Wounds and Injuries; Dissociative Disorders; Knee Injuries
• Other Study ID Numbers: KB-98/2021

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