Anterior Cruciate Ligament Injuries Clinical Trial
Official title:
Clinical and Comparative Evaluation of the Results of Autograft Healing of the Tendon of the Semitendinus Muscle in the Tibial Canal, After Reconstruction of the Anterior Cruciate Ligament of the Knee Joint, by the Method of Stabilization of the Screw With a Bioabsorbable Method, With or Without the Use of Autogenous Spongiform Bone Grafts.
Clinical and comparative evaluation of the results of autograft healing of the tendon of the semitendinus muscle in the tibial canal, after reconstruction of the anterior cruciate ligament of the knee joint, by the method of stabilization of the screw with a bioabsorbable method, with or without the use of autogenous spongiform bone grafts.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | August 13, 2022 |
Est. primary completion date | August 13, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Age 18-65 years; - Surgery for ACL damage to the knee joint; - Arthroscopic surgery; - No prior knee surgical interventions; - No additional pathologies in this anatomical area; - Informed consent of the patient to participate in the study. Exclusion Criteria: - Age under 18 or over 65; - Previous surgical interventions in the examined anatomical area; - Additional pathologies in this area identified as part of preoperative diagnostics; - Damage to the second knee joint; - Failure to comply with the rigor of the same rehabilitation treatment protocol. |
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 | 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 | Tegner Activity 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 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 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 | 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 | 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 | 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 | Magnetic resonance imaging (MRI) | 1,5 Tesli | 6 months after procedure | |
Primary | Ultrasonography (USG) | Ultrasound examination on the apparatus with the option of elastometry | 6 months after procedure | |
Primary | Biomechanical examination | On the Biodex 3 System measuring device | 3 months after procedure | |
Primary | Biomechanical examination | On the Biodex 3 System measuring device | 6 months after procedure |
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