Clinical trial NCT05318118: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Meniscus; Detachment, Current Injury
Detachment
Medial Mensical Tear
Medial Meniscus Knee Injury
Keywords: meniscus;
medial;
injury;
suture;
techniques;
Lead sponsor: eMKa MED Medical Center
Sponsor class: OTHER
Collaborators: name: Wroclaw Medical University
First posted: 2022-04-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Tegner Activity Level Scale (TAS);
timeFrame: 1 day
measure: Tegner Activity Level Scale (TAS);
timeFrame: 3 months after procedure
measure: Tegner Activity Level Scale (TAS);
timeFrame: 6 months after procedure
measure: Tegner Activity Level Scale (TAS);
timeFrame: 12 months after procedure
measure: Visual Analogue Score (VAS)
timeFrame: 1 day
measure: Visual Analogue Score (VAS)
timeFrame: 3 months after procedure
measure: Visual Analogue Score (VAS)
timeFrame: 6 months after procedure
measure: Visual Analogue Score (VAS)
timeFrame: 12 months after procedure
measure: IKDC SUBJECTIVE KNEE EVALUATION FORM
timeFrame: 1 day
measure: IKDC SUBJECTIVE KNEE EVALUATION FORM
timeFrame: 3 months after procedure
measure: IKDC SUBJECTIVE KNEE EVALUATION FORM
timeFrame: 6 months after procedure
measure: IKDC SUBJECTIVE KNEE EVALUATION FORM
timeFrame: 12 months after procedure
measure: Knee Society Score (KSS);
timeFrame: 1 day
measure: Knee Society Score (KSS);
timeFrame: 3 months after procedure
measure: Knee Society Score (KSS);
timeFrame: 6 months after procedure
measure: Knee Society Score (KSS);
timeFrame: 12 months after procedure
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS);
timeFrame: 1 day
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS);
timeFrame: 3 months after procedure
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS);
timeFrame: 6 months after procedure
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS);
timeFrame: 12 months after procedure
measure: Tegner Lysholm Knee Scoring Scale;
timeFrame: 1 day
measure: Tegner Lysholm Knee Scoring Scale;
timeFrame: 3 months after procedure
measure: Tegner Lysholm Knee Scoring Scale;
timeFrame: 6 months after procedure
measure: Tegner Lysholm Knee Scoring Scale;
timeFrame: 12 months after procedure
measure: Body Mass Index (BMI)
timeFrame: 1 day
measure: Body Mass Index (BMI)
timeFrame: 3 months after procedure
measure: Body Mass Index (BMI)
timeFrame: 6 months after procedure
measure: Body Mass Index (BMI)
timeFrame: 12 months after procedure
measure: Biomechanical examination
timeFrame: 9 months after procedure
measure: Biomechanical examination
timeFrame: 12 months after procedure
measure: Ultrasound examination (USG)
timeFrame: 6 months after procedure
measure: Ultrasound examination (USG)
timeFrame: 12 months after procedure
measure: Magnetic resonance imaging (MRI)
timeFrame: 6 months after procedure
measure: Magnetic resonance imaging (MRI)
timeFrame: 12 months after procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Wrocław
country: Poland
facility: eMKa MED Medical Center
state: Dolnośląsk
Study officials:
References: