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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Medial Collateral Ligament Reconstruction With Anteromedial Reinforcement
Sponsored by
Artromedical Konrad Malinowski Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Collateral Ligament, Knee; Sprain (Strain), Medial

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Artromedical Orthopaedic ClinicRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Main arm of the study

Arm 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.

Outcomes

Primary Outcome Measures

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
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
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
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
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
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Min of 0 max of 100 points, higher scores mean a better outcome
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Min of 0 max of 100 points, higher scores mean a better outcome
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Min of 0 max of 100 points, higher scores mean a better outcome
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Min of 0 max of 100 points, higher scores mean a better outcome
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Min of 0 max of 100 points, higher scores mean a better outcome

Secondary Outcome Measures

Full Information

First Posted
August 3, 2022
Last Updated
July 21, 2023
Sponsor
Artromedical Konrad Malinowski Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05489627
Brief Title
Medial Collateral Ligament Reconstruction With Anteromedial Reinforcement for Medial and Anteromedial Rotatory Knee Instability
Official Title
Medial Collateral Ligament Reconstruction With Anteromedial Reinforcement for Medial and Anteromedial Rotatory Knee Instability
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Artromedical Konrad Malinowski Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Collateral Ligament, Knee; Sprain (Strain), Medial, Anterior Cruciate Ligament Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group: Clinical trials with a single arm.
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Main arm of the study
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Medial Collateral Ligament Reconstruction With Anteromedial Reinforcement
Intervention 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.
Primary Outcome Measure Information:
Title
The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)
Description
Min of 0 max of 87 points, higher scores mean a better outcome
Time Frame
Before the surgery
Title
The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)
Description
Min of 0 max of 87 points, higher scores mean a better outcome
Time Frame
At the 3 month of the follow-up.
Title
The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)
Description
Min of 0 max of 87 points, higher scores mean a better outcome
Time Frame
At the 6 month of the follow-up.
Title
The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)
Description
Min of 0 max of 87 points, higher scores mean a better outcome
Time Frame
At the 12 month of the follow-up.
Title
The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)
Description
Min of 0 max of 87 points, higher scores mean a better outcome
Time Frame
At the 24 month of the follow-up.
Title
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Description
Min of 0 max of 100 points, higher scores mean a better outcome
Time Frame
Before the surgery
Title
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Description
Min of 0 max of 100 points, higher scores mean a better outcome
Time Frame
At the 3 month of the follow-up.
Title
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Description
Min of 0 max of 100 points, higher scores mean a better outcome
Time Frame
At the 6 month of the follow-up.
Title
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Description
Min of 0 max of 100 points, higher scores mean a better outcome
Time Frame
At the 12 month of the follow-up.
Title
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Description
Min of 0 max of 100 points, higher scores mean a better outcome
Time Frame
At the 24 month of the follow-up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Konrad Malinowski, MD PhD
Phone
+48 509812212
Email
malwin8@wp.pl
Facility Information:
Facility Name
Artromedical Orthopaedic Clinic
City
Bełchatów
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Konrad Malinowski, MD PhD
Phone
+48 509 812 212
Email
malwin8@wp.pl

12. IPD Sharing Statement

Citations:
PubMed Identifier
31700776
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.
Results Reference
background
PubMed Identifier
33796589
Citation
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.
Results Reference
background
PubMed Identifier
30997548
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.
Results Reference
background
PubMed Identifier
28651635
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.
Results Reference
background
PubMed Identifier
23625060
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.
Results Reference
background
PubMed Identifier
21909850
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.
Results Reference
background
PubMed Identifier
19336612
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.
Results Reference
background
PubMed Identifier
18827242
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.
Results Reference
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Medial Collateral Ligament Reconstruction With Anteromedial Reinforcement for Medial and Anteromedial Rotatory Knee Instability

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