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

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05489627
• Other study ID #: 3-pro-ar-2022
• Status: Recruiting
• Phase: N/A
• Start date: August 31, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: July 2023
• Source: Artromedical Konrad Malinowski Clinic
• Contact: Konrad Malinowski, MD PhD
• Phone: +48 509812212
• Email: malwin8[@]wp.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 17
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Sprains and Strains

Intervention

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.

Locations

Country	Name	City	State
Poland	Artromedical Orthopaedic Clinic	Belchatów

Sponsors (1)

Lead Sponsor	Collaborator
Artromedical Konrad Malinowski Clinic

Country where clinical trial is conducted

Poland, 

References & Publications (8)

Alm L, Drenck TC, Frings J, Krause M, Korthaus A, Krukenberg A, Frosch KH, Akoto R. Lower Failure Rates and Improved Patient Outcome Due to Reconstruction of the MCL and Revision ACL Reconstruction in Chronic Medial Knee Instability. Orthop J Sports Med. 2021 Mar 15;9(3):2325967121989312. doi: 10.1177/2325967121989312. eCollection 2021 Mar. — View Citation

Kim SJ, Lee DH, Kim TE, Choi NH. Concomitant reconstruction of the medial collateral and posterior oblique ligaments for medial instability of the knee. J Bone Joint Surg Br. 2008 Oct;90(10):1323-7. doi: 10.1302/0301-620X.90B10.20781. — View Citation

Kitamura N, Ogawa M, Kondo E, Kitayama S, Tohyama H, Yasuda K. A novel medial collateral ligament reconstruction procedure using semitendinosus tendon autograft in patients with multiligamentous knee injuries: clinical outcomes. Am J Sports Med. 2013 Jun;41(6):1274-81. doi: 10.1177/0363546513485716. Epub 2013 Apr 26. — View Citation

Laprade RF, Wijdicks CA. Surgical technique: development of an anatomic medial knee reconstruction. Clin Orthop Relat Res. 2012 Mar;470(3):806-14. doi: 10.1007/s11999-011-2061-1. — View Citation

Lee DW, Kim JG. Anatomic medial complex reconstruction in serious medial knee instability results in excellent mid-term outcomes. Knee Surg Sports Traumatol Arthrosc. 2020 Mar;28(3):725-732. doi: 10.1007/s00167-019-05367-9. Epub 2019 Apr 17. — View Citation

Lind M, Jakobsen BW, Lund B, Hansen MS, Abdallah O, Christiansen SE. Anatomical reconstruction of the medial collateral ligament and posteromedial corner of the knee in patients with chronic medial collateral ligament instability. Am J Sports Med. 2009 Jun;37(6):1116-22. doi: 10.1177/0363546509332498. Epub 2009 Mar 31. — View Citation

Malinowski K, Hermanowicz K, Goralczyk A, LaPrade RF. Medial Collateral Ligament Reconstruction With Anteromedial Reinforcement for Medial and Anteromedial Rotatory Instability of the Knee. Arthrosc Tech. 2019 Jul 18;8(8):e807-e814. doi: 10.1016/j.eats.2019.03.019. eCollection 2019 Aug. — View Citation

Xu H, Kang K, Zhang J, Xin D, Liu W, Jin G, Dong J, Gao S. An anatomical-like triangular-vector ligament reconstruction for the medial collateral ligament and the posterior oblique ligament injury with single femoral tunnel: a retrospective study. J Orthop Surg Res. 2017 Jun 26;12(1):96. doi: 10.1186/s13018-017-0602-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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
Primary	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.
Primary	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.
Primary	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.
Primary	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.