Meniscus; Detachment, Current InjuryNCT05318118
Comparison of the Results of Arthroscopic Suturing of the Medial Meniscus Using the Fast Fix and FiberStitch Systems
A study testing Medial Meniscus Arthroscopic Reconstruction Using the Fast Fix and Medial Meniscus Arthroscopic Reconstruction Using the Fiber Stitch in people with Meniscus; Detachment, Current Injury and Detachment, run by eMKa MED Medical Center at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Meniscus; Detachment, Current Injury, Detachment, Medial Mensical Tear
- What is being tested?
- Medial Meniscus Arthroscopic Reconstruction Using the Fast Fix and Medial Meniscus Arthroscopic Reconstruction Using the Fiber Stitch
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 8 Mar 2021to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
eMKa MED Medical Center
Wroclaw, Dolnośląsk, 53-110
Maciej Kentel, MD, +48518744908, emkamed.cm@gmail.com
Kacper Kentel, master's degree, +48695263711, kacper.kentel@emkamed.com.pl
About this study
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.
Read the 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.
- Conditions
- Meniscus; Detachment, Current Injury, Detachment, Medial Mensical Tear, Medial Meniscus Knee Injury
- Being tested
- Medial Meniscus Arthroscopic Reconstruction Using the Fast Fix, Medial Meniscus Arthroscopic Reconstruction Using the Fiber Stitch
- Keywords
- meniscus;, medial;, injury;, suture;, techniques;
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medial Meniscus Arthroscopic Reconstruction Using the Fast FixProcedure or surgery
Arthroscopic reconstruction of damaged Medial Meniscus using Fast-Fix (Smith \& Nephew) implant.
Medial Meniscus Arthroscopic Reconstruction Using the Fiber StitchProcedure or surgery
Arthroscopic reconstruction of damaged Medial Meniscus using Fiber-Stitch (Arthrex) implant
| Study group | Role | What they receive |
|---|---|---|
| Medial Meniscus Arthroscopic Reconstruction Using the Fast Fix | Active comparator | Not described Receives: Procedure: Medial Meniscus Arthroscopic Reconstruction Using the Fast Fix |
| Medial Meniscus Arthroscopic Reconstruction Using the Fiber Stitch | Active comparator | Not described Receives: Procedure: Medial Meniscus Arthroscopic Reconstruction Using the Fiber Stitch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months after procedure
Biomechanical examination
On the Biodex 3 System measuring device
Measured: 9 months after procedure
Biomechanical examination
On the Biodex 3 System measuring device
Measured: 12 months after procedure
Ultrasound examination (USG)
Ultrasound examination on the apparatus with the option of elastometry
Measured: 6 months after procedure
Ultrasound examination (USG)
Ultrasound examination on the apparatus with the option of elastometry
Measured: 12 months after procedure
Magnetic resonance imaging (MRI)
1,5 Tesli
Measured: 6 months after procedure
Magnetic resonance imaging (MRI)
1,5 Tesli
Measured: 12 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start8 Mar 2021
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscus; Detachment, Current InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- eMKa MED Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Wroclaw Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318118
- Sponsor's protocol ID
- KB-98/2021
- Status last verified
- Mar 2022
- First submitted
- 22 Mar 2021
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative of Clinical and Evaluation Results of Medial Meniscus Arthroscopic Reconstruction Using the Fast Fix and FiberStitch Systems
- ClinicalTrials.gov ID
- NCT05318118
- Acronym / sponsor ID
- KB-98/2021
- Conditions
- Meniscus; Detachment, Current Injury, Detachment, Medial Mensical Tear, Medial Meniscus Knee Injury
- Keywords
- meniscus;, medial;, injury;, suture;, techniques;
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- eMKa MED Medical CenterUniversity, hospital or other
- Collaborators
- Wroclaw Medical University
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Medial Meniscus Arthroscopic Reconstruction Using the Fast Fix | Active comparator | Procedure: Medial Meniscus Arthroscopic Reconstruction Using the Fast Fix |
| Medial Meniscus Arthroscopic Reconstruction Using the Fiber Stitch | Active comparator | Procedure: Medial Meniscus Arthroscopic Reconstruction Using the Fiber Stitch |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medial Meniscus Arthroscopic Reconstruction Using the Fast FixArthroscopic reconstruction of damaged Medial Meniscus using Fast-Fix (Smith \& Nephew) implant. | Procedure or surgery | Medial Meniscus Arthroscopic Reconstruction Using the Fast Fix |
| Medial Meniscus Arthroscopic Reconstruction Using the Fiber StitchArthroscopic reconstruction of damaged Medial Meniscus using Fiber-Stitch (Arthrex) implant | Procedure or surgery | Medial Meniscus Arthroscopic Reconstruction Using the Fiber Stitch |
Primary outcome
Tegner Activity Level Scale (TAS);
Time frame: 1 day
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);
Time frame: 3 months after procedure
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);
Time frame: 6 months after procedure
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);
Time frame: 12 months after procedure
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)
Time frame: 1 day
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)
Time frame: 3 months after procedure
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)
Time frame: 6 months after procedure
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)
Time frame: 12 months after procedure
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
Time frame: 1 day
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
Time frame: 3 months after procedure
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
Time frame: 6 months after procedure
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
Time frame: 12 months after procedure
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);
Time frame: 1 day
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);
Time frame: 3 months after procedure
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);
Time frame: 6 months after procedure
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);
Time frame: 12 months after procedure
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);
Time frame: 1 day
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);
Time frame: 3 months after procedure
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);
Time frame: 6 months after procedure
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);
Time frame: 12 months after procedure
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;
Time frame: 1 day
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;
Time frame: 3 months after procedure
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;
Time frame: 6 months after procedure
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;
Time frame: 12 months after procedure
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)
Time frame: 1 day
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)
Time frame: 3 months after procedure
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)
Time frame: 6 months after procedure
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)
Time frame: 12 months after procedure
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
Time frame: 9 months after procedure
On the Biodex 3 System measuring device
Biomechanical examination
Time frame: 12 months after procedure
On the Biodex 3 System measuring device
Ultrasound examination (USG)
Time frame: 6 months after procedure
Ultrasound examination on the apparatus with the option of elastometry
Ultrasound examination (USG)
Time frame: 12 months after procedure
Ultrasound examination on the apparatus with the option of elastometry
Magnetic resonance imaging (MRI)
Time frame: 6 months after procedure
1,5 Tesli
Magnetic resonance imaging (MRI)
Time frame: 12 months after procedure
1,5 Tesli
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medial Meniscus Arthroscopic Reconstruction Using the Fast Fix and Medial Meniscus Arthroscopic Reconstruction Using the Fiber Stitch in people with Meniscus; Detachment, Current Injury and Detachment, run by eMKa MED Medical Center at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maciej Kentel, MD PhD (+48518744908, emkamed.cm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tegner Activity Level Scale (TAS); (time frame: 1 day). The study lists 34 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.