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.

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.

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 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 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; Procedure: 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

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.

• 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: All

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;
• 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.

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: ACL Reconstruction with the use of autogenous spongiform bone grafts; 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.	Procedure: 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; 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.
ACTIVE_COMPARATOR: ACL Reconstruction without the use of autogenous spongiform bone grafts; Stabilization of the tibial attachment with a bioabsorbable screw (Arthrex) without simultaneous application of autogenous cancellous bone grafts to the tibial canal.	Procedure: 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.	1 day
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.	3 months after procedure
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.	6 months after procedure

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 13, 2021
• Primary Completion (ANTICIPATED): August 13, 2022
• Study Completion (ANTICIPATED): August 13, 2022

Study Registration Dates

• First Submitted: March 30, 2022
• First Submitted That Met QC Criteria: April 7, 2022
• First Posted (ACTUAL): April 14, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Reconstruction; Rupture; Injury; Techniques; Damage
• Additional Relevant MeSH Terms: Leg Injuries; Wounds and Injuries; Rupture; Anterior Cruciate Ligament Injuries; Knee Injuries
• Other Study ID Numbers: KB-688/2021

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