Medial Mensical Tear Clinical Trial
Official title:
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.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | September 1, 2022 |
| Est. primary completion date | September 1, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 35 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Poland | eMKa MED Medical Center | Wroclaw | Dolnoslask |
| Lead Sponsor | Collaborator |
|---|---|
| eMKa MED Medical Center | Wroclaw Medical University |
Poland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | Biomechanical examination | On the Biodex 3 System measuring device | 9 months after procedure | |
| Primary | Biomechanical examination | On the Biodex 3 System measuring device | 12 months after procedure | |
| Primary | Ultrasound examination (USG) | Ultrasound examination on the apparatus with the option of elastometry | 6 months after procedure | |
| Primary | Ultrasound examination (USG) | Ultrasound examination on the apparatus with the option of elastometry | 12 months after procedure | |
| Primary | Magnetic resonance imaging (MRI) | 1,5 Tesli | 6 months after procedure | |
| Primary | Magnetic resonance imaging (MRI) | 1,5 Tesli | 12 months after procedure |