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

Sponsor
Artromedical Konrad Malinowski Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05489627
Collaborator
(none)
17
1
1
40
0.4

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Medial Collateral Ligament Reconstruction With Anteromedial Reinforcement
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
17 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single Group: Clinical trials with a single arm.Single Group: Clinical trials with a single arm.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Medial Collateral Ligament Reconstruction With Anteromedial Reinforcement for Medial and Anteromedial Rotatory Knee Instability
Anticipated Study Start Date :
Aug 31, 2022
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC) [Before the surgery]

    Min of 0 max of 87 points, higher scores mean a better outcome

  2. The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC) [At the 3 month of the follow-up.]

    Min of 0 max of 87 points, higher scores mean a better outcome

  3. The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC) [At the 6 month of the follow-up.]

    Min of 0 max of 87 points, higher scores mean a better outcome

  4. The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC) [At the 12 month of the follow-up.]

    Min of 0 max of 87 points, higher scores mean a better outcome

  5. The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC) [At the 24 month of the follow-up.]

    Min of 0 max of 87 points, higher scores mean a better outcome

  6. The functional assessment with the Knee injury and Osteoarthritis Outcome Score [Before the surgery]

    Min of 0 max of 100 points, higher scores mean a better outcome

  7. The functional assessment with the Knee injury and Osteoarthritis Outcome Score [At the 3 month of the follow-up.]

    Min of 0 max of 100 points, higher scores mean a better outcome

  8. The functional assessment with the Knee injury and Osteoarthritis Outcome Score [At the 6 month of the follow-up.]

    Min of 0 max of 100 points, higher scores mean a better outcome

  9. The functional assessment with the Knee injury and Osteoarthritis Outcome Score [At the 12 month of the follow-up.]

    Min of 0 max of 100 points, higher scores mean a better outcome

  10. The functional assessment with the Knee injury and Osteoarthritis Outcome Score [At the 24 month of the follow-up.]

    Min of 0 max of 100 points, higher scores mean a better outcome

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Artromedical Orthopaedic Clinic Bełchatów Poland

Sponsors and Collaborators

  • Artromedical Konrad Malinowski Clinic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Konrad Malinowski MD, Konrad Malinowski MD, Artromedical Konrad Malinowski Clinic, Artromedical Konrad Malinowski Clinic
ClinicalTrials.gov Identifier:
NCT05489627
Other Study ID Numbers:
  • 3-pro-ar-2022
First Posted:
Aug 5, 2022
Last Update Posted:
Aug 5, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 5, 2022