Posteromedial Tibiofemoral Incongruence (PMTFI) Treatment

NCT05882591 | Recruiting

• 1 other identifier: 4-pro-ar-2023
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Meniscus Disorder; Meniscus; Degeneration; Meniscus Tear; Meniscus Lesion

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)

  At the 12 month of the follow-up

• The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)

  At the 24 month of the follow-up

• The functional assessment with the Knee injury and Osteoarthritis Outcome Score (KOOS)

  At the 12 month of the follow-up.

• The functional assessment with the Knee injury and Osteoarthritis Outcome Score (KOOS)

  At the 24 month of the follow-up.

Study Arms (1)

Main arm of the study

EXPERIMENTAL

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).

Interventions

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).

Main arm of the study

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Artromedical Konrad Malinowski Clinic: lead

Study Sites (1)

Artromedical Orthopaedic Clinic

Bełchatów, Łódź Voivodeship, 97-400, Poland

RECRUITING

Related Publications (3)

• 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.

  PMID: 35782837 RESULT

• 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.

  PMID: 20141980 RESULT

• 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.

  PMID: 11956982 RESULT

Study Officials

• Konrad Malinowski, MD PhD

  Artromedical Orthopaedic Clinic, Bełchatów, Poland

  PRINCIPAL INVESTIGATOR

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: Konrad Malinowski MD, Director of Artromedical Konrad Malinowski Clinic and Principal Investigator

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: May 20, 2023
• First Posted: May 31, 2023
• Study Start: October 9, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 31, 2023

Record last verified: 2023-05

Locations

PL (1)