Anterior Cruciate Ligament Reconstruction With Quadriceps Tendon Bone Autograft

Study Overview
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Brief Summary
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Anterior cruciate ligament injuries are one of the most common sports knee injuries. Their effect on the knee joint can be detrimental with patients experiencing instability and progressive damage of the intraarticular structures. Therefore, anterior cruciate ligament reconstruction (ACLR) is often indicated. Multiple graft option exist, including autograft, allograft and xenograft tissues, with autografts being considered as a first-choice source of reconstructed ligament in most cases. Two most common harvested autografts are hamstring tendons (semitendinosus or semitendinosus and gracilis tendons; ST or STG) and patellar tendon with two bone blocks (bone - patellar tendon - bone; BPTB). However, in the recent literature there is an increasing trend towards use of quadriceps tendon autograft (QT). Multiple techniques of harvesting this graft were described, including both partial and complete thickness of the tendon. Another issue is whether bone block from the upper pole of the patella is harvested along with the soft tissues (quadriceps tendon bone graft, QTB). The aim of this study is to add to the body of knowledge concerning full-thickness quadriceps tendon-bone autograft (QTB) used in ACLR. The primary outcome consists of The International Knee Documentation Committee Questionnaire (IKDC), the Knee injury and Osteoarthritis Outcome Score (KOOS) and retear rate.

Official Title
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Anterior Cruciate Ligament Reconstruction With Quadriceps Tendon Bone Autograft

Conditions
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Anterior Cruciate Ligament Tear, Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture

Intervention / Treatment
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* Procedure: Arthroscopic anterior cruciate ligament reconstruction with quadriceps tendon bone autograft (QTB)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic knee anterior and rotatory instability after ACL injury; Primary ACLR cases Exclusion Criteria: Active inflammation of the knee; Revision cases; Additional PLC, PCL or PFJ injuries (MCL and meniscal lesions are not exclusion criteria); Fractures around the knee

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single Group: Clinical trials with a single arm.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Main arm of the study<br>Arthroscopic anterior cruciate ligament reconstruction with quadriceps tendon bone autograft (QTB) will be performed in these patients. | Procedure: Arthroscopic anterior cruciate ligament reconstruction with quadriceps tendon bone autograft (QTB)<br>* Arthroscopic anterior cruciate ligament reconstruction with quadriceps tendon bone autograft (QTB) will be performed in these patients. QTB autografts will be harvested as described in the published technique: K. Malinowski, J. Paszkowski, M. Mostowy, A. Góralczyk, R.F. LaPrade, K. Hermanowicz, Quadriceps Tendon-Bone Full-Thickness Autograft: Reproducible and Easy Harvesting Technique Using Simple Surgical Tools, Arthrosc. Tech. 10 (2021) e1165-e1172. https://doi.org/10.1016/j.eats.2021.01.003. ACLR will be performed utilizing anteromedial technique with management of any accompanying intraarticular lesions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee stability | Anterior and anterolateral rotatory knee stability assessed by the means of instrumented Lachman test and pivot-shift test. | At the 12 month of the follow-up. | 
| Knee stability | Anterior and anterolateral rotatory knee stability assessed by the means of instrumented Lachman test and pivot-shift test. | At the 24 month of the follow-up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC) | Min of 0 max of 87 points, higher scores mean a better outcome | At the 12 month of the follow-up. | 
| The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC) | Min of 0 max of 87 points, higher scores mean a better outcome | At the 24 month of the follow-up. | 
| The functional assessment with the Knee injury and Osteoarthritis Outcome Score | Min of 0 max of 100 points, higher scores mean a better outcome | At the 12 month of the follow-up. | 
| The functional assessment with the Knee injury and Osteoarthritis Outcome Score | Min of 0 max of 100 points, higher scores mean a better outcome | At the 24 month of the follow-up. | 
| Retear rate | Rate of patients with retear of the reconstructed ligament | At the 12 month of the follow-up. | 
| Retear rate | Rate of patients with retear of the reconstructed ligament | At the 24 month of the follow-up. | 
| ROM | Knee range of motion assessed by the means of goniometer. | At the 12 month of the follow-up. | 
| ROM | Knee range of motion assessed by the means of goniometer. | At the 24 month of the follow-up. |