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临床试验/NCT05318118
NCT05318118Unknown不适用

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

eMKa MED Medical Center2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年3月8日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
2
主要终点
Tegner Activity Level Scale (TAS);

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Tegner Activity Level Scale (TAS);

时间窗: 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.

Knee Injury and Osteoarthritis Outcome Score (KOOS);

时间窗: 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;

时间窗: 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.

IKDC SUBJECTIVE KNEE EVALUATION FORM

时间窗: 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.

Ultrasound examination (USG)

时间窗: 12 months after procedure

Ultrasound examination on the apparatus with the option of elastometry

Visual Analogue Score (VAS)

时间窗: 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.

Biomechanical examination

时间窗: 12 months after procedure

On the Biodex 3 System measuring device

Body Mass Index (BMI)

时间窗: 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.

Knee Society Score (KSS);

时间窗: 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.

Magnetic resonance imaging (MRI)

时间窗: 12 months after procedure

1,5 Tesli

次要结局

未报告次要终点

研究者

发起方
eMKa MED Medical Center
申办方类型
Other
责任方
Sponsor

研究点 (2)

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