Posteromedial Tibiofemoral Incongruence (PMTFI) Treatment

• Sponsor: Artromedical Konrad Malinowski Clinic (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05882591
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 86.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Meniscus Disorder; Meniscus; Degeneration; Meniscus Tear; Meniscus Lesion	Procedure: Posteromedial Tibiofemoral Incongruence (PMTFI) Treatment by the means of published technique (reference nr 1).	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Single Group AssignmentSingle Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Posteromedial Tibiofemoral Incongruence (PMTFI) Treatment
• Actual Study Start Date: Oct 9, 2020
• Anticipated Primary Completion Date: Dec 31, 2026
• Anticipated Study Completion Date: Dec 31, 2027

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

1. Presence of pain in full knee flexion [At the 12 month of the follow-up]

   Presence of pain in full knee flexion - deep squat: pain yes/no

2. Presence of pain in full knee flexion [At the 24 month of the follow-up]

   Presence of pain in full knee flexion - deep squat: pain yes/no

Secondary Outcome Measures

1. 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

2. 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

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

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

4. The functional assessment with the Knee injury and Osteoarthritis Outcome Score (KOOS) [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 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Artromedical Orthopaedic Clinic	Bełchatów	Łódzkie	Poland	97-400

Sponsors and Collaborators

• Artromedical Konrad Malinowski Clinic

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Konrad Malinowski MD, Konrad Malinowski MD, Director of Artromedical Konrad Malinowski Clinic and Principal Investigator, Artromedical Konrad Malinowski Clinic
• ClinicalTrials.gov Identifier: NCT05882591
• Other Study ID Numbers: 4-pro-ar-2023
• First Posted: May 31, 2023
• Last Update Posted: May 31, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 31, 2023