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.

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 Overview

• Status: Recruiting
• Conditions: Anterior Cruciate Ligament Injuries; Anterior Cruciate Ligament Rupture; Anterior Cruciate Ligament Tear; Knee Injuries; Knee Ligament Injury
• Intervention / Treatment: Procedure: ACL Reconstruction using an autograph of the peroneus longus tendon, folded twice.; Procedure: ACL Reconstruction using an autograph of Hamstrings muscle tendons.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Dolnośląsk
    • Wrocław, Dolnośląsk, Poland, 53-110
      • Recruiting
      • eMKa MED Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Evaluation of functional results and survival rate of peroneus longus tendon used for ACLR.	Procedure: ACL Reconstruction using an autograph of the peroneus longus tendon, folded twice.; The use of a peroneus longus tendon autograft taken from the lower leg of the same limb and used as a graft to reconstruct the ACL (anterior cruciate ligament) of the knee joint.
ACTIVE_COMPARATOR: Evaluation of functional results and survival rate of hamstring tendon used for ACL reconstruction.	Procedure: ACL Reconstruction using an autograph of Hamstrings muscle tendons.; The use of Hamstring muscle tendon autograft (Semitendinus and slender muscle) taken from the lower leg of the same limb and used as a graft to reconstruct the ACL (anterior cruciate ligament) of the knee joint.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tegner Activity Level 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 Level 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
Tegner Activity Level 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
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
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
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
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
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
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
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
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
The American Orthopedic Foot and Ankle Score (AOFAS)	is a standardized evaluation of the clinical status of the ankle-hindfoot. It incorporates both subjective and objective information. Patients report their pain, and physicians assess alignment. The patient and physician work together to complete the functional portion.each measure is comprised of nine questions and cover three categories: Pain (40 points), function (50 points) and alignment (10 points). These are all scored together for a total of 100 points. Scores range from 0 to 100, with healthy ankles receiving 100 points.	1 day
The American Orthopedic Foot and Ankle Score (AOFAS)	is a standardized evaluation of the clinical status of the ankle-hindfoot. It incorporates both subjective and objective information. Patients report their pain, and physicians assess alignment. The patient and physician work together to complete the functional portion.each measure is comprised of nine questions and cover three categories: Pain (40 points), function (50 points) and alignment (10 points). These are all scored together for a total of 100 points. Scores range from 0 to 100, with healthy ankles receiving 100 points.	3 month after procedure
The American Orthopedic Foot and Ankle Score (AOFAS)	is a standardized evaluation of the clinical status of the ankle-hindfoot. It incorporates both subjective and objective information. Patients report their pain, and physicians assess alignment. The patient and physician work together to complete the functional portion.each measure is comprised of nine questions and cover three categories: Pain (40 points), function (50 points) and alignment (10 points). These are all scored together for a total of 100 points. Scores range from 0 to 100, with healthy ankles receiving 100 points.	6 month after procedure

Collaborators and Investigators

• Sponsor: eMKa MED Medical Center
• Collaborators: Wroclaw Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 2, 2022
• Primary Completion (ANTICIPATED): February 2, 2024
• Study Completion (ANTICIPATED): February 9, 2024

Study Registration Dates

• First Submitted: March 30, 2022
• First Submitted That Met QC Criteria: October 12, 2022
• First Posted (ACTUAL): October 13, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 13, 2022
• Last Update Submitted That Met QC Criteria: October 12, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: ACL; Reconstruction; Injuries; Rupture; Techniques; Tear
• Additional Relevant MeSH Terms: Leg Injuries; Wounds and Injuries; Rupture; Anterior Cruciate Ligament Injuries; Knee Injuries
• Other Study ID Numbers: KB-84/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No