Posteromedial Tibiofemoral Incongruence (PMTFI) Treatment

The aim of this study is to assess outcomes of Posteromedial Tibiofemoral Incongruence (PMTFI) Treatment

Study Overview

• Status: Recruiting
• Conditions: Meniscus; Degeneration; Meniscus Lesion; Meniscus Tear; Meniscus Disorder
• Intervention / Treatment: Procedure: Posteromedial Tibiofemoral Incongruence (PMTFI) Treatment by the means of published technique (reference nr 1).

Detailed Description

The aim of this study is to assess outcomes of Posteromedial Tibiofemoral Incongruence (PMTFI) Treatment by the means of published technique (reference nr 1).

A decrease in the posterior curvature of the femoral metaphysis close to the medial femoral condyle is one of the anatomical alterations that can be seen within the knee joint. When the knee is fully flexed, this curve is typically concave enough to accommodate the posterior horn of the medial meniscus (PHMM). Similar to cam incongruence in the hip joint, a decrease in curvature may cause posteromedial tibiofemoral incongruence, a condition marked by compression of the PHMM in complete knee flexion. If deep knee flexion occurs, clinical symptoms may appear, and PHMM degeneration may be shown to worsen over time. Surgery may be recommended for patients for whom activity modification and conservative therapy have failed. Our team proposed an arthroscopic procedure that allows for the least amount of correction that is still necessary while also providing final intraoperative confirmation of the clinical need to repair posteromedial tibiofemoral incongruence.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Konrad Malinowski, MD PhD; Phone Number: +48 509812212; Email: malwin8@wp.pl

Study Locations

• Poland
  • Łódzkie
    • Bełchatów, Łódzkie, Poland, 97-400
      • Recruiting
      • Artromedical Orthopaedic Clinic
      • Contact: Konrad Malinowski, MD PhD; Phone Number: +48 509 812 212; Email: malwin8@wp.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pain, snapping or discomfort in posterior part of the knee in deep knee flexion during squat
• Reduced concavity of the femoral metaphysis proximal to the medial femoral condyle confirmed on MRI
• Impingement of posterior horn of medial meniscus with the metaphysis of femur during full knee flexion confirmed arthroscopically

Exclusion Criteria:

• Active knee inflammation
• Chondral injuries ICRS 3-4
• Extraarticular reasons of pain, snapping or discomfort in posterior part of the knee in deep knee flexion during squat
• Cyst or avascular changes within the femoral metaphysis adjacent to the planned localization of the procedure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Main arm of the study; Posteromedial Tibiofemoral Incongruence (PMTFI) Treatment by the means of published technique (reference nr 1).	Procedure: Posteromedial Tibiofemoral Incongruence (PMTFI) Treatment by the means of published technique (reference nr 1).; Posteromedial Tibiofemoral Incongruence (PMTFI) Treatment by the means of published technique (reference nr 1).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of pain in full knee flexion	Presence of pain in full knee flexion - deep squat: pain yes/no	At the 12 month of the follow-up
Presence of pain in full knee flexion	Presence of pain in full knee flexion - deep squat: pain yes/no	At the 24 month of the follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The functional assessment with the Knee injury and Osteoarthritis Outcome Score (KOOS)	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 (KOOS)	Min of 0 max of 100 points, higher scores mean a better outcome	At the 24 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

Collaborators and Investigators

• Sponsor: Artromedical Konrad Malinowski Clinic
• Investigators: Principal Investigator: Konrad Malinowski, MD PhD, Artromedical Orthopaedic Clinic, Bełchatów, Poland

Publications and helpful links

General Publications

• Malinowski K, Kozlak M, Mostowy M, LaPrade RF, Ebisz M, Pekala PA. Cam Impingement of the Knee: Arthroscopic Correction of Posteromedial Tibiofemoral Incongruence. Arthrosc Tech. 2022 May 11;11(6):e951-e957. doi: 10.1016/j.eats.2022.01.015. eCollection 2022 Jun.
• Suganuma J, Mochizuki R, Yamaguchi K, Inoue Y, Yamabe E, Ueda Y, Fujinaka T. Cam impingement of the posterior femoral condyle in medial meniscal tears. Arthroscopy. 2010 Feb;26(2):173-83. doi: 10.1016/j.arthro.2009.11.002.
• Suganuma J. Lack of posteromedial tibiofemoral congruence at full flexion as a causative factor in isolated medial meniscal tears. J Orthop Sci. 2002;7(2):217-25. doi: 10.1007/s007760200036.

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: May 20, 2023
• First Submitted That Met QC Criteria: May 20, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 20, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 4-pro-ar-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No