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

July 21, 2023 updated by: Konrad Malinowski MD, Artromedical Konrad Malinowski Clinic
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Estimated)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Konrad Malinowski, MD PhD
  • Phone Number: +48 509812212
  • Email: malwin8@wp.pl

Study Locations

  • Poland
      • Bełchatów, Poland
        • Recruiting
        • Artromedical Orthopaedic Clinic
        • Contact:
          • Konrad Malinowski, MD PhD
          • Phone Number: +48 509 812 212
          • Email: malwin8@wp.pl

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Main arm of the study

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)
Time Frame: Before the surgery
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)
Time Frame: At the 3 month of the follow-up.
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)
Time Frame: At the 6 month of the follow-up.
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)
Time Frame: At the 12 month of the follow-up.
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)
Time Frame: At the 24 month of the follow-up.
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
Time Frame: Before the surgery
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
Time Frame: At the 3 month of the follow-up.
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
Time Frame: At the 6 month of the follow-up.
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
Time Frame: At the 12 month of the follow-up.
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
Time Frame: At the 24 month of the follow-up.
Min of 0 max of 100 points, higher scores mean a better outcome
At the 24 month of the follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Artromedical Konrad Malinowski Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2022

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

August 3, 2022

First Submitted That Met QC Criteria

August 3, 2022

First Posted (Actual)

August 5, 2022

Study Record Updates

Last Update Posted (Estimated)

July 24, 2023

Last Update Submitted That Met QC Criteria

July 21, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-pro-ar-2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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