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

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

Sponsors

Lead Sponsor: Artromedical Konrad Malinowski Clinic

Source Artromedical Konrad Malinowski Clinic
Brief Summary

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).

Overall Status Recruiting
Start Date 2022-08-31
Completion Date 2025-12-31
Primary Completion Date 2025-12-31
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC) Before the surgery
The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC) At the 3 month of the follow-up.
The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC) At the 6 month of the follow-up.
The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC) At the 12 month of the follow-up.
The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC) At the 24 month of the follow-up.
The functional assessment with the Knee injury and Osteoarthritis Outcome Score Before the surgery
The functional assessment with the Knee injury and Osteoarthritis Outcome Score At the 3 month of the follow-up.
The functional assessment with the Knee injury and Osteoarthritis Outcome Score At the 6 month of the follow-up.
The functional assessment with the Knee injury and Osteoarthritis Outcome Score At the 12 month of the follow-up.
The functional assessment with the Knee injury and Osteoarthritis Outcome Score At the 24 month of the follow-up.
Enrollment 17
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Medial Collateral Ligament Reconstruction With Anteromedial Reinforcement

Description: 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.

Arm Group Label: Main arm of the study

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

60 Years

Healthy Volunteers:

No

Overall Contact

Last Name: Konrad Malinowski, MD PhD

Phone: +48 509812212

Email: [email protected]

Location
Facility: Status: Contact: Artromedical Orthopaedic Clinic Konrad Malinowski, MD PhD +48 509 812 212 [email protected]
Location Countries

Poland

Verification Date

2022-08-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Artromedical Konrad Malinowski Clinic

Investigator Full Name: Konrad Malinowski MD

Investigator Title: Konrad Malinowski MD, Artromedical Konrad Malinowski Clinic

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Main arm of the study

Type: Experimental

Description: 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.

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention Model Description: Single Group: Clinical trials with a single arm.

Primary Purpose: Treatment

Masking: None (Open Label)

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 [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Collateral Ligament, Knee; Sprain (Strain), Medial

Clinical Trials on Medial Collateral Ligament Reconstruction With Anteromedial Reinforcement