Meniscus DisorderNCT05882591
Posteromedial Tibiofemoral Incongruence (PMTFI) Treatment
A study testing Posteromedial Tibiofemoral Incongruence (PMTFI) Treatment by the means of published technique (reference nr 1). in people with Meniscus Disorder and Meniscus; Degeneration, run by Artromedical Konrad Malinowski Clinic at 1 site in Poland.
Trial summary
The aim of this study is to assess outcomes of Posteromedial Tibiofemoral Incongruence (PMTFI) Treatment Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Meniscus Disorder, Meniscus; Degeneration, Meniscus Tear
- What is being tested?
- Posteromedial Tibiofemoral Incongruence (PMTFI) Treatment by the means of published technique (reference nr 1).
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 sitePoland
- Study dates
- 9 Oct 2020to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Artromedical Orthopaedic Clinic
Bełchatów, Łódź Voivodeship, 97-400
Konrad Malinowski, MD PhD, +48 509 812 212, malwin8@wp.pl
About this study
The aim of this study is to assess outcomes of Posteromedial Tibiofemoral Incongruence (PMTFI) Treatment
Read the 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.
- Being tested
- Posteromedial Tibiofemoral Incongruence (PMTFI) Treatment by the means of published technique (reference nr 1).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posteromedial Tibiofemoral Incongruence (PMTFI) Treatment by the means of published technique (reference nr 1).Procedure or surgery
Posteromedial Tibiofemoral Incongruence (PMTFI) Treatment by the means of published technique (reference nr 1).
| Study group | Role | What they receive |
|---|---|---|
| Main arm of the study | Experimental | Posteromedial Tibiofemoral Incongruence (PMTFI) Treatment by the means of published technique (reference nr 1). Receives: Procedure: Posteromedial Tibiofemoral Incongruence (PMTFI) Treatment by the means of published technique (reference nr 1). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of pain in full knee flexion
Presence of pain in full knee flexion - deep squat: pain yes/no
Measured: 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
Measured: At the 24 month of the follow-up
Secondary outcomes (4)
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
Measured: 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
Measured: At the 24 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
Measured: 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
Measured: At the 24 month of the follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start9 Oct 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Meniscus DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Artromedical Konrad Malinowski Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konrad Malinowski MD, Artromedical Konrad Malinowski Clinic
- Investigators
- Konrad Malinowski, MD PhD, Principal investigator, Artromedical Orthopaedic Clinic, Bełchatów, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882591
- Sponsor's protocol ID
- 4-pro-ar-2023
- Status last verified
- May 2023
- First submitted
- 20 May 2023
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 35782837Suganuma 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.
PubMed 20141980Suganuma 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.
PubMed 11956982
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posteromedial Tibiofemoral Incongruence (PMTFI) Treatment
- ClinicalTrials.gov ID
- NCT05882591
- Acronym / sponsor ID
- 4-pro-ar-2023
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Artromedical Konrad Malinowski ClinicUniversity, hospital or other
- Study start
- 9 Oct 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Main arm of the study | Experimental | 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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Procedure or surgery | Main arm of the study |
Primary outcome
Presence of pain in full knee flexion
Time frame: At the 12 month of the follow-up
Presence of pain in full knee flexion - deep squat: pain yes/no
Presence of pain in full knee flexion
Time frame: At the 24 month of the follow-up
Presence of pain in full knee flexion - deep squat: pain yes/no
4 secondary outcomes
The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)
Time frame: At the 12 month of the follow-up
The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)
Time frame: At the 24 month of the follow-up
The functional assessment with the Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: At the 12 month of the follow-up.
The functional assessment with the Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: At the 24 month of the follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Results publication: PubMed 35782837Malinowski 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 publication: PubMed 20141980Suganuma 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 publication: PubMed 11956982Suganuma 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Konrad Malinowski, MD PhD principal investigator
Artromedical Orthopaedic Clinic, Bełchatów, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posteromedial Tibiofemoral Incongruence (PMTFI) Treatment by the means of published technique (reference nr 1). in people with Meniscus Disorder and Meniscus; Degeneration, run by Artromedical Konrad Malinowski Clinic at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Konrad Malinowski, MD PhD (+48 509812212, malwin8@wp.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of pain in full knee flexion (time frame: At the 12 month of the follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05882591, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023; AzTrials last refreshed its copy on 9 Nov 2026.