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| Name | Class |
|---|---|
| Wroclaw Medical University | OTHER |
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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.
Assessment of the results of autograft healing of the tendon of the semitendinus muscle in the tibial canal, after the reconstruction of the anterior cruciate ligament (ACL) of the knee joint using the arthroscopic technique, with the method of tibial stabilization with a bioabsorbable screw (Arthrex) with the use of autogenous transplantation of spongy bone, drilling of the tibial canal inserted into the tibial canal prior to insertion of the screw. The detailed objectives are: comparison of the treatment results - healing and reconstruction of the autograft of the semitendinus tendon in the tibial canal of the knee joint, obtained in the study groups using two methods:
A- stabilization of the tibial attachment with a bioabsorbable screw (Arthrex) with simultaneous application to the tibial canal of autogenous cancellous bone grafts taken during the drilling of this canal and
B- stabilization of the tibial insertion with a bioabsorbable screw (Arthrex) without simultaneous application of autogenous cancellous bone grafts to the tibial canal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACL Reconstruction with the use of autogenous spongiform bone grafts | Experimental | Stabilization of the tibial insertion with a bioabsorbable screw (Arthrex) with simultaneous application to the tibial canal of autogenous cancellous bone grafts taken during the drilling of this canal. |
|
| ACL Reconstruction without the use of autogenous spongiform bone grafts | Active Comparator | Stabilization of the tibial attachment with a bioabsorbable screw (Arthrex) without simultaneous application of autogenous cancellous bone grafts to the tibial canal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACL reconstruction of the knee joint by arthroscopic technique, with the tibial fixation method using a bioabsorbable screw (Arthrex) with the use of autogenous cancellous bone grafts | Procedure | Reconstruction of the anterior cruciate ligament (ACL) of the joint the knee stabilization method, a bioabsorbable screw with the use of an autogenous spongy bone graft taken during drilling of the tibial canal into the tibial canate before inserting the screw. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Score (VAS) | Visual Analogue Score - subjective measure for acute and chronic pain. 100-mm VAS ratings of:
| 1 day |
| Visual Analogue Score (VAS) | Visual Analogue Score - subjective measure for acute and chronic pain. 100-mm VAS ratings of:
| 3 months after procedure |
| Visual Analogue Score (VAS) | Visual Analogue Score - subjective measure for acute and chronic pain. 100-mm VAS ratings of:
| 6 months after procedure |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maciej Kentel, MD PhD | Contact | +48518744908 | emkamed.cm@gmail.com | |
| Kacper Kentel, Master's degree | Contact | +48695263711 | kacper.kentel@emkamed.com.pl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| eMKa MED Medical Center | Recruiting | Wroclaw | Dolnośląsk | 53-110 | Poland |
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A- stabilization of the tibial attachment with a bioabsorbable screw (Arthrex) with simultaneous application to the tibial canal of autogenous cancellous bone grafts taken during the drilling of this canal; B- stabilization of the tibial insertion with a bioabsorbable screw (Arthrex) without simultaneous application of autogenous cancellous bone grafts to the tibial canal.
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| ACL reconstruction of the knee joint by arthroscopic technique, with the tibial fixation method using a bioabsorbable screw (Arthrex) without the use of autogenous cancellous bone grafts | Procedure | Reconstruction of the anterior cruciate ligament (ACL) of the joint the knee stabilization method, a bioabsorbable screw without the use of an autogenous spongy bone graft taken during drilling of the tibial canal into the tibial canate before inserting the screw. |
|
| 3 months after procedure |
| 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 |
| 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 |
| 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 |
| 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 |
| 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:
| 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:
| 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:
| 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. | 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. | 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. | 6 months after procedure |
| Magnetic resonance imaging (MRI) | 1,5 Tesli | 6 months after procedure |
| Ultrasonography (USG) | Ultrasound examination on the apparatus with the option of elastometry | 6 months after procedure |
| Biomechanical examination | On the Biodex 3 System measuring device | 3 months after procedure |
| Biomechanical examination | On the Biodex 3 System measuring device | 6 months after procedure |
| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| D007718 | Knee Injuries |
| D014947 | Wounds and Injuries |
| D012421 | Rupture |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
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