Clinical trial NCT05579067: Comparative Evaluation of Functional Results and Survival Rate of Peroneus Longus Tendon - PLT and Hamstring Tendon - HT Used for Reconstruction of the Anterior Cruciate Ligament.
Official title: Comparative Evaluation of Functional Results and Survival Rate of Peroneus Longus Tendon - PLT and Hamstring Tendon - HT Used for Reconstruction of the Anterior Cruciate Ligament.
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: Injuries
Rupture
Tear
ACL
Reconstruction
Techniques
Lead sponsor: eMKa MED Medical Center
Sponsor class: OTHER
Collaborators: name: Wroclaw Medical University
First posted: 2022-10-13
Enrollment: 60
Sex: MALE
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- the use of a peroneus longus tendon autograft taken from the lower leg of the same limb and used as a graft for ACL reconstruction (anterior cruciate ligament) of the knee joint;

B- the use of Hamstring muscle tendon autograft (Semitendonus and slender muscle) taken from the lower leg of the same limb and used as a graft for ACL reconstruction (anterior cruciate ligament) of the knee joint
Primary purpose: TREATMENT

Brief summary: Comparative evaluation of functional results and survival rate of peroneus longus tendon - PLT and hamstring tendon - HT used for reconstruction of the anterior cruciate ligament.

Detailed description: Comparison of treatment results - survival and reconstruction of autographs and functional results of the knee joint, and functional results of the ankle joint, obtained in the study groups operated using two methods:

A- the use of a long fibular tendon autograft taken from the lower leg of the same limb and used as a graft for ACL reconstruction (anterior cruciate ligament) of the knee joint; B- the use of Hamstring muscle tendon autograft (Semitendonus and slender muscle) taken from the lower leg of the same limb and used as a graft for ACL reconstruction (anterior cruciate ligament) of the knee joint.

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;
* Patient informed consent to participate in research.

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 Level Scale (TAS)
timeFrame: 1 day
measure: Tegner Activity Level Scale (TAS)
timeFrame: 3 months after procedure
measure: Tegner Activity Level 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: The American Orthopedic Foot and Ankle Score (AOFAS)
timeFrame: 1 day
measure: The American Orthopedic Foot and Ankle Score (AOFAS)
timeFrame: 3 month after procedure
measure: The American Orthopedic Foot and Ankle Score (AOFAS)
timeFrame: 6 month after procedure
measure: Biomechanical examination
timeFrame: 3 months after procedure
measure: Biomechanical examination
timeFrame: 6 months after procedure
measure: Ultrasonography (USG)
timeFrame: 6 months after procedure
measure: Magnetic resonance imaging (MRI)
timeFrame: 6 months after procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Wrocław
country: Poland
facility: eMKa MED Medical Center
state: Dolnośląsk
Study officials:
References: