Medial Collateral LigamentNCT06863077
Knee Medial Collateral Ligament Recovery After Pie-Crusting Release Technique
An observational study of Medial Collateral Ligament and Medial Mensical Tear, run by Kastamonu University at 1 site in Turkey (Türkiye).
Trial summary
Medial meniscus tears requiring surgical interventions are mostly being done by arthroscopic procedures. During the arthroscopy, accessing the medial joint space is challenging. Because of this situation, pie-crusting of the medial collateral ligament (MCL) of the knee is described. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medial Collateral Ligament, Medial Mensical Tear, Shear Wave Elastography
- What is being tested?
- MCL Pie-Crusting
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Jan 2025to 30 Apr 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with medial meniscal injury
Who may be able to join
- Being 18 years of age or older
- Having a medial meniscus laceration detected in the magnetic resonance imaging taken due to the application for knee complaints and therefore having an indication for surgery
- Having consented to the surgical consent form explaining surgical and non-surgical options, accepting the surgical procedure
- Having consented to the research volunteer consent form presented to him/her verbally and in writing after giving his/her consent for surgery
Who cannot join
- Having had a previous fracture, meniscus tear, anterior or posterior cruciate ligament tear, medial or lateral collateral ligament tear in the same or opposite knee.
- Having had arthroscopic or open surgery around the knee due to or outside of the above reasons.
- Having had or not had surgery on the same lower extremity or the opposite lower extremity, having a fracture sequela or deformity.
- Having grade 1 or higher arthrosis according to the Kellgren-Lawrence arthrosis classification on direct radiographs taken before surgery.
- Patients who do not require medial collateral ligament release to access the medial joint space during surgery and therefore do not require pie-crusting medial collateral ligament release.
- Patients who wish to withdraw their consent given to the research volunteer consent form at any time during the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kastamonu Education and Research Hospital
Kastamonu, 37000
About this study
Official title: The Evaluation of Knee Medial Collateral Ligament Recovery With Shear-Wave Elastography After Pie-Crusting Release Technique
Medial meniscus tears requiring surgical interventions are mostly being done by arthroscopic procedures. During the arthroscopy, accessing the medial joint space is challenging. Because of this situation, pie-crusting of the medial collateral ligament (MCL) of the knee is described. This procedure is to release the MCL 1 cm distal to its origin with a needle-tip. This release provides enough space for both identifying the tear and also provides enough space to introduce necessary equipment in the joint space for repair. But there are some doubts about MCL release. Some authors suspected ongoing valgus instability after this procedure. Our aim is to identify the tension of MCL with USG shear wave elastography before the procedure, and 3 weeks, 6 weeks and 3 months postoperatively.
Read the detailed description
Meniscal lesions are common orthopedic injuries. Posterior horn and medial meniscus root injuries are frequently seen as isolated cases or in association with ligament injuries ( 1 , 2 ). Arthroscopy is the preferred treatment method, and proper visualization of the medial compartment of the knee is crucial for correct diagnosis and treatment. Arthroscopic visualization of the posteromedial aspect of the knee may be difficult in patients with medial narrow knee joints and no ligament injuries ( 1 , 2 ); inadequate visualization may lead to treatment failure with persistent symptoms such as pain, crepitation, or locking of the joint. Femoral or tibial cartilage damage may occur during arthroscopy due to the narrowness of the medial compartment of the knee, due to the instruments used, which may lead to secondary osteoarthritis or to rupture of the medial collateral ligament (MCL) during valgus stress if excessive force is applied to open the medial joint space. During difficult manipulations, damage and breakage of arthroscopic instruments may occur. Therefore, in order to optimize imaging and intervention in medial knee joint pathologies, it is recommended to perform prophylactic controlled percutaneous needle-assisted loosening of the superficial medial collateral ligament during the operation (pie-crusting). However, there is a concern that the medial collateral ligament may not heal and laxity may develop. There are studies in the literature on patients who underwent medial collateral ligament loosening with the piecrusting method. In these studies, improvement has been shown in functional scores, physical examination (valgus stress), magnetic resonance imaging and knee valgus stress radiographs. However, the healing time and whether the medial collateral ligament has regained its former morphological characteristics have not been quantitatively demonstrated.
Share wave elastography uses sound waves to evaluate the mechanical properties of tissues such as stiffness and elasticity. They are used to detect different pathologies in tissues by using the differences in the mechanical properties mentioned above. Tissue stiffness is calculated using a physical property of tissue called Young's modulus or modulus of elasticity. Young's modulus is defined as the ratio of stress (force applied to the cross-sectional area of a given material) to strain (i.e., deformation; in this case, tissue deformation). The unit of Young's modulus is Pa (Pascal) or the SI unit is N/m2. The sonographic elastography value is usually in kPa (kilopascal) in most clinical settings. Patients who are scheduled for surgery with a diagnosis of medial meniscus tear will be evaluated ultrasonographically by 2 different radiologists in the preoperative period. Both knees will have medial collateral ligament share wave elastography performed and recorded. In patients who have undergone medial collateral ligament pie crusting for imaging of the knee medial compartment during the operation, share wave elastographic measurements will be performed by the same 2 radiologists again in the 3rd, 6th and 12th weeks after the operation. At the same time, the functional scores and examination findings of these patients in their outpatient clinic follow-ups will be noted. Preoperative and contralateral knee medial collateral ligament measurements of the patients will be used as the control group.
- Being tested
- MCL Pie-Crusting
- Keywords
- medial collateral ligament, pie-crusting, shear wave elastography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCL Pie-CrustingProcedure or surgery
Percutaneous MCL Pie-Crusting
| Study group | Role | What they receive |
|---|---|---|
| Pie-Crusting | MCL Pie-Crusting Receives: Procedure: MCL Pie-Crusting |
What is being measured
The primary outcome is the main question the study is designed to answer.
MCL recovery
The shear wave elastography measured strain values of medial collateral ligament
Measured: Preoperative and three months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start22 Jan 2025
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Medial Collateral LigamentStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Kastamonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Ali Sabır, Kastamonu University
- Investigators
- Mehmet Ali Sabır Sabır, M.D., Principal investigator, Kastamonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06863077
- Sponsor's protocol ID
- 2024-KAEK-199
- Status last verified
- Mar 2026
- First submitted
- 22 Jan 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: During the writing process of the research, the age, operated side, preoperative value and postoperative follow-up values of shear wave elastographys are planned to be shared with the other researchers in the article.
Publications
Herber AP, Brinkman JC, Tummala SV, Economopoulos KJ. Medial Collateral Ligament Pie-Crusting for Isolated Medial Meniscal Root Repair Is Associated With Improved Clinical Outcomes with Minimum 2-Year Follow-Up. Arthroscopy. 2024 Mar;40(3):869-875. doi: 10.1016/j.arthro.2023.07.029. Epub 2023 Jul 31.
PubMed 37532161Atoun E, Debbi R, Lubovsky O, Weiler A, Debbi E, Rath E. Arthroscopic trans-portal deep medial collateral ligament pie-crusting release. Arthrosc Tech. 2013 Jan 26;2(1):e41-3. doi: 10.1016/j.eats.2012.10.008. Print 2013 Feb.
PubMed 23802093
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Knee Medial Collateral Ligament Recovery With Shear-Wave Elastography After Pie-Crusting Release Technique
- ClinicalTrials.gov ID
- NCT06863077
- Acronym / sponsor ID
- 2024-KAEK-199
- Keywords
- medial collateral ligament, pie-crusting, shear wave elastography
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kastamonu UniversityUniversity, hospital or other
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 7 Mar 2025 (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.
Medial meniscus tears requiring surgical interventions are mostly being done by arthroscopic procedures. During the arthroscopy, accessing the medial joint space is challenging. Because of this situation, pie-crusting of the medial collateral ligament (MCL) of the knee is described. This procedure is to release the MCL 1 cm distal to its origin with a needle-tip. This release provides enough space for both identifying the tear and also provides enough space to introduce necessary equipment in the joint space for repair. But there are some doubts about MCL release. Some authors suspected ongoing valgus instability after this procedure. Our aim is to identify the tension of MCL with USG shear wave elastography before the procedure, and 3 weeks, 6 weeks and 3 months postoperatively.
Detailed description
Meniscal lesions are common orthopedic injuries. Posterior horn and medial meniscus root injuries are frequently seen as isolated cases or in association with ligament injuries ( 1 , 2 ). Arthroscopy is the preferred treatment method, and proper visualization of the medial compartment of the knee is crucial for correct diagnosis and treatment. Arthroscopic visualization of the posteromedial aspect of the knee may be difficult in patients with medial narrow knee joints and no ligament injuries ( 1 , 2 ); inadequate visualization may lead to treatment failure with persistent symptoms such as pain, crepitation, or locking of the joint. Femoral or tibial cartilage damage may occur during arthroscopy due to the narrowness of the medial compartment of the knee, due to the instruments used, which may lead to secondary osteoarthritis or to rupture of the medial collateral ligament (MCL) during valgus stress if excessive force is applied to open the medial joint space. During difficult manipulations, damage and breakage of arthroscopic instruments may occur. Therefore, in order to optimize imaging and intervention in medial knee joint pathologies, it is recommended to perform prophylactic controlled percutaneous needle-assisted loosening of the superficial medial collateral ligament during the operation (pie-crusting). However, there is a concern that the medial collateral ligament may not heal and laxity may develop. There are studies in the literature on patients who underwent medial collateral ligament loosening with the piecrusting method. In these studies, improvement has been shown in functional scores, physical examination (valgus stress), magnetic resonance imaging and knee valgus stress radiographs. However, the healing time and whether the medial collateral ligament has regained its former morphological characteristics have not been quantitatively demonstrated.
Share wave elastography uses sound waves to evaluate the mechanical properties of tissues such as stiffness and elasticity. They are used to detect different pathologies in tissues by using the differences in the mechanical properties mentioned above. Tissue stiffness is calculated using a physical property of tissue called Young's modulus or modulus of elasticity. Young's modulus is defined as the ratio of stress (force applied to the cross-sectional area of a given material) to strain (i.e., deformation; in this case, tissue deformation). The unit of Young's modulus is Pa (Pascal) or the SI unit is N/m2. The sonographic elastography value is usually in kPa (kilopascal) in most clinical settings. Patients who are scheduled for surgery with a diagnosis of medial meniscus tear will be evaluated ultrasonographically by 2 different radiologists in the preoperative period. Both knees will have medial collateral ligament share wave elastography performed and recorded. In patients who have undergone medial collateral ligament pie crusting for imaging of the knee medial compartment during the operation, share wave elastographic measurements will be performed by the same 2 radiologists again in the 3rd, 6th and 12th weeks after the operation. At the same time, the functional scores and examination findings of these patients in their outpatient clinic follow-ups will be noted. Preoperative and contralateral knee medial collateral ligament measurements of the patients will be used as the control group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pie-Crusting | – | Procedure: MCL Pie-CrustingMCL Pie-Crusting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with medial meniscal injury
Key inclusion criteria (4 listed)
- Being 18 years of age or older
- Having a medial meniscus laceration detected in the magnetic resonance imaging taken due to the application for knee complaints and therefore having an indication for surgery
- Having consented to the surgical consent form explaining surgical and non-surgical options, accepting the surgical procedure
- Having consented to the research volunteer consent form presented to him/her verbally and in writing after giving his/her consent for surgery
Key exclusion criteria (6 listed)
- Having had a previous fracture, meniscus tear, anterior or posterior cruciate ligament tear, medial or lateral collateral ligament tear in the same or opposite knee.
- Having had arthroscopic or open surgery around the knee due to or outside of the above reasons.
- Having had or not had surgery on the same lower extremity or the opposite lower extremity, having a fracture sequela or deformity.
- Having grade 1 or higher arthrosis according to the Kellgren-Lawrence arthrosis classification on direct radiographs taken before surgery.
- Patients who do not require medial collateral ligament release to access the medial joint space during surgery and therefore do not require pie-crusting medial collateral ligament release.
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 |
|---|---|---|
| MCL Pie-CrustingPercutaneous MCL Pie-Crusting | Procedure or surgery | Pie-Crusting |
Primary outcome
MCL recovery
Time frame: Preoperative and three months postoperative
The shear wave elastography measured strain values of medial collateral ligament
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 10 Mar 2026.
- Background: PubMed 37532161Herber AP, Brinkman JC, Tummala SV, Economopoulos KJ. Medial Collateral Ligament Pie-Crusting for Isolated Medial Meniscal Root Repair Is Associated With Improved Clinical Outcomes with Minimum 2-Year Follow-Up. Arthroscopy. 2024 Mar;40(3):869-875. doi: 10.1016/j.arthro.2023.07.029. Epub 2023 Jul 31.
- Background: PubMed 23802093Atoun E, Debbi R, Lubovsky O, Weiler A, Debbi E, Rath E. Arthroscopic trans-portal deep medial collateral ligament pie-crusting release. Arthrosc Tech. 2013 Jan 26;2(1):e41-3. doi: 10.1016/j.eats.2012.10.008. Print 2013 Feb.
- Individual participant dataSharing planned: No. During the writing process of the research, the age, operated side, preoperative value and postoperative follow-up values of shear wave elastographys are planned to be shared with the other researchers in the article.
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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. This study is not recruiting at the moment.
Mehmet Ali Sabır Sabır, M.D. principal investigator
Kastamonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medial Collateral Ligament and Medial Mensical Tear, run by Kastamonu University at 1 site in Turkey (Türkiye).
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 4 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 10 Mar 2026. 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 Turkey (Türkiye). 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MCL recovery (time frame: Preoperative and three months postoperative). 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 NCT06863077, which also lists 2 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 10 Mar 2026.