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

NCT05489627 | Unknown

• 1 other identifier: 3-pro-ar-2022
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (10)

• 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.

Study Arms (1)

Main arm of the study

EXPERIMENTAL

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

Interventions

Medial Collateral Ligament Reconstruction With Anteromedial Reinforcement PROCEDURE

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.

Main arm of the study

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Symptomatic knee medial and anteromedial rotatory instability associated with anterior and rotatory instability after an MCL + ACL injury
• Primary cases

You may not qualify if:

• 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

Sponsors & Collaborators

• Artromedical Konrad Malinowski Clinic: lead

Study Sites (1)

Artromedical Orthopaedic Clinic

Bełchatów, Poland

RECRUITING

Related Publications (8)

• 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.

  PMID: 31700776 BACKGROUND

• 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.

  PMID: 33796589 BACKGROUND

• 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.

  PMID: 30997548 BACKGROUND

• 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.

  PMID: 28651635 BACKGROUND

• 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.

  PMID: 23625060 BACKGROUND

• 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.

  PMID: 21909850 BACKGROUND

• 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.

  PMID: 19336612 BACKGROUND

• 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.

  PMID: 18827242 BACKGROUND

MeSH Terms

Conditions

Sprains and Strains; Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries; Knee Injuries; Leg Injuries

Central Study Contacts

Konrad Malinowski, MD PhD

CONTACT

+48 509812212; malwin8@wp.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Konrad Malinowski MD, Artromedical Konrad Malinowski Clinic

Model Details: Single Group: Clinical trials with a single arm.

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 5, 2022
• Study Start: August 31, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 24, 2023

Record last verified: 2023-07

Locations

PL (1)