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Posteromedial Tibiofemoral Incongruence (PMTFI) Treatment

Primary Purpose

Meniscus Disorder, Meniscus; Degeneration, Meniscus Tear

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Posteromedial Tibiofemoral Incongruence (PMTFI) Treatment by the means of published technique (reference nr 1).
Sponsored by
Artromedical Konrad Malinowski Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meniscus Disorder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Artromedical Orthopaedic ClinicRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Main arm of the study

Arm Description

Posteromedial Tibiofemoral Incongruence (PMTFI) Treatment by the means of published technique (reference nr 1).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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

Full Information

First Posted
May 20, 2023
Last Updated
May 20, 2023
Sponsor
Artromedical Konrad Malinowski Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05882591
Brief Title
Posteromedial Tibiofemoral Incongruence (PMTFI) Treatment
Official Title
Posteromedial Tibiofemoral Incongruence (PMTFI) Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 9, 2020 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Artromedical Konrad Malinowski Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meniscus Disorder, Meniscus; Degeneration, Meniscus Tear, Meniscus Lesion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Main arm of the study
Arm Type
Experimental
Arm Description
Posteromedial Tibiofemoral Incongruence (PMTFI) Treatment by the means of published technique (reference nr 1).
Intervention Type
Procedure
Intervention Name(s)
Posteromedial Tibiofemoral Incongruence (PMTFI) Treatment by the means of published technique (reference nr 1).
Intervention Description
Posteromedial Tibiofemoral Incongruence (PMTFI) Treatment by the means of published technique (reference nr 1).
Primary Outcome Measure Information:
Title
Presence of pain in full knee flexion
Description
Presence of pain in full knee flexion - deep squat: pain yes/no
Time Frame
At the 12 month of the follow-up
Title
Presence of pain in full knee flexion
Description
Presence of pain in full knee flexion - deep squat: pain yes/no
Time Frame
At the 24 month of the follow-up
Secondary Outcome Measure Information:
Title
The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)
Description
Min of 0 max of 87 points, higher scores mean a better outcome
Time Frame
At the 12 month of the follow-up
Title
The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)
Description
Min of 0 max of 87 points, higher scores mean a better outcome
Time Frame
At the 24 month of the follow-up
Title
The functional assessment with the Knee injury and Osteoarthritis Outcome Score (KOOS)
Description
Min of 0 max of 100 points, higher scores mean a better outcome
Time Frame
At the 12 month of the follow-up.
Title
The functional assessment with the Knee injury and Osteoarthritis Outcome Score (KOOS)
Description
Min of 0 max of 100 points, higher scores mean a better outcome
Time Frame
At the 24 month of the follow-up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Konrad Malinowski, MD PhD
Phone
+48 509812212
Email
malwin8@wp.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konrad Malinowski, MD PhD
Organizational Affiliation
Artromedical Orthopaedic Clinic, Bełchatów, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Artromedical Orthopaedic Clinic
City
Bełchatów
State/Province
Łódzkie
ZIP/Postal Code
97-400
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Konrad Malinowski, MD PhD
Phone
+48 509 812 212
Email
malwin8@wp.pl

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35782837
Citation
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.
Results Reference
result
PubMed Identifier
20141980
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.
Results Reference
result
PubMed Identifier
11956982
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.
Results Reference
result

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Posteromedial Tibiofemoral Incongruence (PMTFI) Treatment

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