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.
Primary Purpose
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear
Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
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
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
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Cruciate Ligament Injuries focused on measuring Injury, Rupture, Damage, Reconstruction, Techniques
Eligibility Criteria
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.
Sites / Locations
- eMKa MED Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ACL Reconstruction with the use of autogenous spongiform bone grafts
ACL Reconstruction without the use of autogenous spongiform bone grafts
Arm Description
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.
Stabilization of the tibial attachment with a bioabsorbable screw (Arthrex) without simultaneous application of autogenous cancellous bone grafts to the tibial canal.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Magnetic resonance imaging (MRI)
1,5 Tesli
Ultrasonography (USG)
Ultrasound examination on the apparatus with the option of elastometry
Biomechanical examination
On the Biodex 3 System measuring device
Biomechanical examination
On the Biodex 3 System measuring device
Secondary Outcome Measures
Full Information
NCT ID
NCT05328544
First Posted
March 30, 2022
Last Updated
April 7, 2022
Sponsor
eMKa MED Medical Center
Collaborators
Wroclaw Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05328544
Brief Title
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.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 13, 2021 (Actual)
Primary Completion Date
August 13, 2022 (Anticipated)
Study Completion Date
August 13, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
eMKa MED Medical Center
Collaborators
Wroclaw Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear, Knee Injuries, Knee Ligament Injury
Keywords
Injury, Rupture, Damage, Reconstruction, Techniques
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ACL Reconstruction with the use of autogenous spongiform bone grafts
Arm Type
Experimental
Arm Description
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.
Arm Title
ACL Reconstruction without the use of autogenous spongiform bone grafts
Arm Type
Active Comparator
Arm Description
Stabilization of the tibial attachment with a bioabsorbable screw (Arthrex) without simultaneous application of autogenous cancellous bone grafts to the tibial canal.
Intervention Type
Procedure
Intervention Name(s)
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
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
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
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analogue Score (VAS)
Description
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.
Time Frame
1 day
Title
Visual Analogue Score (VAS)
Description
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.
Time Frame
3 months after procedure
Title
Visual Analogue Score (VAS)
Description
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.
Time Frame
6 months after procedure
Title
Tegner Activity Scale (TAS)
Description
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.
Time Frame
1 day
Title
Tegner Activity Scale (TAS)
Description
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.
Time Frame
3 months after procedure
Title
Tegner Activity Scale (TAS)
Description
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.
Time Frame
6 months after procedure
Title
IKDC SUBJECTIVE KNEE EVALUATION FORM
Description
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.
Time Frame
1 day
Title
IKDC SUBJECTIVE KNEE EVALUATION FORM
Description
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.
Time Frame
3 months after procedure
Title
IKDC SUBJECTIVE KNEE EVALUATION FORM
Description
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.
Time Frame
6 months after procedure
Title
Tegner Lysholm Knee Scoring Scale
Description
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.
Time Frame
1 day
Title
Tegner Lysholm Knee Scoring Scale
Description
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.
Time Frame
3 months after procedure
Title
Tegner Lysholm Knee Scoring Scale
Description
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.
Time Frame
6 months after procedure
Title
Body Mass Index (BMI)
Description
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.
Time Frame
1 day
Title
Body Mass Index (BMI)
Description
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.
Time Frame
3 months after procedure
Title
Body Mass Index (BMI)
Description
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.
Time Frame
6 months after procedure
Title
Magnetic resonance imaging (MRI)
Description
1,5 Tesli
Time Frame
6 months after procedure
Title
Ultrasonography (USG)
Description
Ultrasound examination on the apparatus with the option of elastometry
Time Frame
6 months after procedure
Title
Biomechanical examination
Description
On the Biodex 3 System measuring device
Time Frame
3 months after procedure
Title
Biomechanical examination
Description
On the Biodex 3 System measuring device
Time Frame
6 months after procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maciej Kentel, MD PhD
Phone
+48518744908
Email
emkamed.cm@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kacper Kentel, Master's degree
Phone
+48695263711
Email
kacper.kentel@emkamed.com.pl
Facility Information:
Facility Name
eMKa MED Medical Center
City
Wrocław
State/Province
Dolnośląsk
ZIP/Postal Code
53-110
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maciej Kentel, MD
Phone
+48518744908
Email
emkamed.cm@gmail.com
First Name & Middle Initial & Last Name & Degree
Kacper Kentel, master's degree
Phone
+48695263711
Email
kacper.kentel@emkamed.com.pl
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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.
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