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.

NCT05328544 | Unknown

• 1 other identifier: KB-688/2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament Injuries; Anterior Cruciate Ligament Rupture; Anterior Cruciate Ligament Tear; Knee Injuries; Knee Ligament Injury

Keywords

Injury; Rupture; Damage; Reconstruction; Techniques

Outcome Measures

Primary Outcomes (19)

• 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

• 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

• 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

• 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

Study Arms (2)

ACL Reconstruction with the use of autogenous spongiform bone grafts

EXPERIMENTAL

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

ACL Reconstruction without the use of autogenous spongiform bone grafts

ACTIVE COMPARATOR

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

Interventions

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

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.

ACL Reconstruction with the use of autogenous spongiform bone grafts

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 PROCEDURE

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.

ACL Reconstruction without the use of autogenous spongiform bone grafts

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• eMKa MED Medical Center: lead
• Wroclaw Medical University: collaborator

Study Sites (1)

eMKa MED Medical Center

Wroclaw, Dolnośląsk, 53-110, Poland

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Knee Injuries; Wounds and Injuries; Rupture

Condition Hierarchy (Ancestors)

Leg Injuries

Central Study Contacts

Maciej Kentel, MD PhD

CONTACT

+48518744908; emkamed.cm@gmail.com

Kacper Kentel, Master's degree

CONTACT

+48695263711; kacper.kentel@emkamed.com.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 14, 2022
• Study Start: August 13, 2021
• Primary Completion: August 13, 2022
• Study Completion: August 13, 2022
• Last Updated: April 14, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)