Clinical trial NCT05328544: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Anterior Cruciate Ligament Injuries
Anterior Cruciate Ligament Rupture
Anterior Cruciate Ligament Tear
Knee Injuries
Knee Ligament Injury
Keywords: Injury
Rupture
Damage
Reconstruction
Techniques
Lead sponsor: eMKa MED Medical Center
Sponsor class: OTHER
Collaborators: name: Wroclaw Medical University
First posted: 2022-04-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
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: Tegner Activity Scale (TAS)
timeFrame: 1 day
measure: Tegner Activity Scale (TAS)
timeFrame: 3 months after procedure
measure: Tegner Activity Scale (TAS)
timeFrame: 6 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: 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: 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: Magnetic resonance imaging (MRI)
timeFrame: 6 months after procedure
measure: Ultrasonography (USG)
timeFrame: 6 months after procedure
measure: Biomechanical examination
timeFrame: 3 months after procedure
measure: Biomechanical examination
timeFrame: 6 months after procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Wrocław
country: Poland
facility: eMKa MED Medical Center
state: Dolnośląsk
Study officials:
References: