Medial Collateral Ligament Reconstruction With Anteromedial Reinforcement for Medial and Anteromedial Rotatory Knee Instability

Study Overview
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Brief Summary
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The aim of this study is to assess the outcomes of the combined quadriceps tendon-bone (QTB) ACLR and MCLR with anteromedial reinforcement performed as described in the published technique: K. Malinowski, K. Hermanowicz, A. Góralczyk, R.F. LaPrade, Medial Collateral Ligament Reconstruction With Anteromedial Reinforcement for Medial and Anteromedial Rotatory Instability of the Knee, Arthrosc. Tech. 8 (2019) e807-e814. https://doi.org/10.1016/j.eats.2019.03.019.

Detailed Description
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Medial collateral ligament (MCL) injuries are one of the most common sports knee injuries, commonly occuring together with anterior cruciate ligament (ACL) injuries. Their effect on the knee joint can be detrimental with patients experiencing medial instability and anteromedial rotatory instability (AMRI), leading to progressive damage of the intraarticular structures. While healing potential of medial knee stabilizing structures is relatively high, medial collateral ligament reconstruction (MCLR) is sometimes indicated. Multiple reconstructions techniques were described, including both procedures utilizing native semitendinosus tendon with distal attachment left intact as well as with auto- or allo-grafts. However, in part of these techniques, AMRI is not addressed. Therefore, the aim of this study is to assess the outcomes of the combined quadriceps tendon-bone (QTB) ACLR and MCLR with anteromedial reinforcement performed as described in the published technique: K. Malinowski, K. Hermanowicz, A. Góralczyk, R.F. LaPrade, Medial Collateral Ligament Reconstruction With Anteromedial Reinforcement for Medial and Anteromedial Rotatory Instability of the Knee, Arthrosc. Tech. 8 (2019) e807-e814. https://doi.org/10.1016/j.eats.2019.03.019. The primary outcome consists of The International Knee Documentation Committee Questionnaire (IKDC) and the Knee injury and Osteoarthritis Outcome Score (KOOS).

Official Title
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Medial Collateral Ligament Reconstruction With Anteromedial Reinforcement for Medial and Anteromedial Rotatory Knee Instability

Conditions
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Collateral Ligament, Knee; Sprain (Strain), Medial, Anterior Cruciate Ligament Injuries

Intervention / Treatment
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* Procedure: Medial Collateral Ligament Reconstruction With Anteromedial Reinforcement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic knee medial and anteromedial rotatory instability associated with anterior and rotatory instability after an MCL + ACL injury Primary cases Exclusion Criteria: Active inflammation of the knee Revision cases Additional PLC, PCL or PFJ injuries fractures around the knee removal of more than ½ of medial or lateral meniscus contralateral knee injury cartilage damage ICRS grade III or higher Non-adherence of the patient to the treatment protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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>Medial knee instabilities will be addressed in this arm. Due to the fact that isolated injury of medial stabilizers of the knees is very rare, included will be patients with D concomitant ACL QTB reconstruction and MCL reconstruction. Any accompanying intraarticular injuries such as meniscal lesions will be addressed as well. 17 patients will be included in this arm - this number was calculated and rounded up as a mean of number patients from studies of Alm et al. 2021 (17 patients in ACLR+MCLR group), Lee et al. 2020 (10 patients in ACLR+MCLR group), Kitamura et al. 2013 (16 patients in ACLR+MCLR group), LaPrade et al. 2012 (8 patients in ACLR+MCLR group), Lind et al. 2009 (34 patients in ACLR+MCLR group) and Kim et al. 2008 (12 patients in ACLR+MCLR group). All above referenced studies apart from the study of LaPrade et al. were retrospective. | Procedure: Medial Collateral Ligament Reconstruction With Anteromedial Reinforcement<br>* Medial knee instabilities will be addressed in this arm as described in the published technique: K. Malinowski, K. Hermanowicz, A. Góralczyk, R.F. LaPrade, Medial Collateral Ligament Reconstruction With Anteromedial Reinforcement for Medial and Anteromedial Rotatory Instability of the Knee, Arthrosc. Tech. 8 (2019) e807-e814. https://doi.org/10.1016/j.eats.2019.03.019. Due to the fact that isolated injury of medial stabilizers of the knees is very rare, included will be patients with concomitant ACL QTB reconstruction and abovedescribed MCL reconstruction. Any accompanying intraarticular injuries such as meniscal lesions will be addressed as well.<br>|

What is the study measuring?
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Primary 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 | Before the surgery | 
| 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 3 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 6 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 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 | Before the surgery | 
| 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 3 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 6 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. |