Knee Medial Collateral Ligament Recovery After Pie-Crusting Release Technique

March 6, 2026 updated by: Mehmet Ali Sabır, Kastamonu University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Kastamonu, Turkey (Türkiye), 37000
        • Kastamonu Education and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with medial meniscal injury

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Pie-Crusting
MCL Pie-Crusting
Procedure: MCL Pie-Crusting
Percutaneous MCL Pie-Crusting

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
MCL recovery
Time Frame: Preoperative and three months postoperative
The shear wave elastography measured strain values of medial collateral ligament
Preoperative and three months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kastamonu University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mehmet Ali Sabır Sabır, M.D., Kastamonu University

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 22, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-KAEK-199

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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