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.

Anterior Cruciate Ligament Injuries Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05579067
• Other study ID #: KB-84/2022
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2022
• Est. completion date: February 9, 2024

Study information

• Verified date: March 2022
• Source: eMKa MED Medical Center
• Contact: Maciej Kentel, MD PhD
• Phone: +48518744908
• Email: emkamed.cm[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 9, 2024
• Est. primary completion date: February 2, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Rupture
• Anterior Cruciate Ligament Tear
• Knee Injuries
• Knee Ligament Injury
• Rupture
• Wounds and Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
Poland	eMKa MED Medical Center	Wroclaw	Dolnoslask

Sponsors (2)

Lead Sponsor	Collaborator
eMKa MED Medical Center	Wroclaw Medical University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Biomechanical examination	On the Biodex 3 System measuring device	3 months after procedure
Primary	Biomechanical examination	On the Biodex 3 System measuring device	6 months after procedure
Primary	Ultrasonography (USG)	Ultrasound examination on the apparatus with the option of elastometry	6 months after procedure
Primary	Magnetic resonance imaging (MRI)	1,5 Tesli	6 months after procedure