Posteromedial Tibiofemoral Incongruence (PMTFI) Treatment

Meniscus Tear Clinical Trial

Official title:

Posteromedial Tibiofemoral Incongruence (PMTFI) Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05882591
• Other study ID #: 4-pro-ar-2023
• Status: Recruiting
• Phase: N/A
• Start date: October 9, 2020
• Est. completion date: December 31, 2027

Study information

• Verified date: May 2023
• Source: Artromedical Konrad Malinowski Clinic
• Contact: Konrad Malinowski, MD PhD
• Phone: +48 509812212
• Email: malwin8[@]wp.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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).

Locations

Country	Name	City	State
Poland	Artromedical Orthopaedic Clinic	Belchatów	Lódzkie

Sponsors (1)

Lead Sponsor	Collaborator
Artromedical Konrad Malinowski Clinic

Country where clinical trial is conducted

Poland, 

References & 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 20 — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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.
Secondary	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.