NCT06863077

Brief 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. 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.

Trial Health

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Trial Health Score

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Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

January 22, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 7, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

January 22, 2025

Last Update Submit

March 6, 2026

Conditions

Keywords

medial collateral ligamentpie-crustingshear wave elastography

Outcome Measures

Primary Outcomes (1)

  • MCL recovery

    The shear wave elastography measured strain values of medial collateral ligament

    Preoperative and three months postoperative

Study Arms (1)

Pie-Crusting

MCL Pie-Crusting

Procedure: MCL Pie-Crusting

Interventions

Percutaneous MCL Pie-Crusting

Pie-Crusting

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with medial meniscal injury

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kastamonu Education and Research Hospital

Kastamonu, 37000, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 37532161BACKGROUND
  • Atoun 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.

    PMID: 23802093BACKGROUND

Study Officials

  • Mehmet Ali Sabır Sabır, M.D.

    Kastamonu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 22, 2025

First Posted

March 7, 2025

Study Start

January 22, 2025

Primary Completion

March 30, 2026

Study Completion

April 30, 2026

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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.

Locations