NCT06906783

Brief Summary

The concept of meniscal extrusion has recently been recognized as an important pathological condition associated with meniscal dysfunction. Meniscal extrusion is the medial or lateral displacement of the meniscus beyond the edges of the tibial plateau. Some meniscal extrusions are physiologic, but large degrees of extrusion are thought to be pathologic. Meniscal extrusion can vary in extent from minimal physiological extrusion to extrusions exceeding 10 mm. The generally accepted threshold value is considered to be 3 mm. To date, the gold standard for measuring meniscal extrusion is T2-weighted MRI. MRI is valuable not only due to its ability to define other meniscal or knee pathologies but also because it provides good sensitivity and specificity. Surgical treatment of meniscal extrusion is preferred in young, active, symptomatic patients and individuals with acute injuries. The treatment approach may vary depending on the underlying cause. One of these methods is centralization surgery, which aims to achieve the anatomical reduction of the extruded meniscus. The aim of this study is to compare the functional outcomes of transtibial pull-out and suture anchor techniques used in centralization surgery and to contribute to standardization.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 2, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

May 4, 2025

Status Verified

April 1, 2025

Enrollment Period

1.3 years

First QC Date

March 26, 2025

Last Update Submit

April 30, 2025

Conditions

Meniscal ExtrusionMeniscus Injury

Keywords

Meniscus ExtrusionSurgical TreatmentTranstibial Pull OutSuture Anchor Method

Outcome Measures

Primary Outcomes (1)

  • Change in the amount of meniscus extrusion in MR images.

    determine the change in the amount of meniscus extrusion in preoperative and postoperative 12th month MR images.

    From enrollment to the end of treatment at 12 months

Secondary Outcomes (3)

  • Lysholm score

    From enrollment to the end of treatment at 3, 6 and 12 months.

  • Tegner activity score

    From enrollment to the end of treatment at 3, 6 and 12 months.

  • International Knee Documentation Committee (IKDC) Score

    From enrollment to the end of treatment at 3, 6 and 12 months.

Study Arms (2)

Transtibial Pull Out Method

ACTIVE COMPARATOR
Procedure: Transtibial Pull Out Method

Suture Anchor Method

ACTIVE COMPARATOR
Procedure: Suture Anchor Method

Interventions

Transtibial Pull Out MethodPROCEDURE

The Transtibial Pull-Out Repair is a surgical technique used to fix posterior root tears of the meniscus, particularly in the medial meniscus. This method restores the hoop stress mechanism of the meniscus, which is essential for knee stability and function.

Transtibial Pull Out Method
Suture Anchor MethodPROCEDURE

The Suture Anchor Technique is an alternative to the Transtibial Pull-Out Method for repairing posterior meniscal root tears, especially in the medial meniscus. Instead of using a tibial tunnel, this technique fixes the meniscal root directly to the native footprint using suture anchors.

Suture Anchor Method

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presence of meniscal extrusion greater than 3 mm on MRI scans
  • Symptomatic complaints in the knee with extrusion

You may not qualify if:

  • Malalignment greater than 5 degrees
  • Presence of Kellgren-Lawrence grade 3-4 osteoarthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University Hospital

Erzurum, Yakutiye, 25100, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • Yan X, Sahu S, Li H, Zhou W, Xiong T, Chen S, Li C, Hao L. Arthroscopic meniscal posterior root repair combined with centralization reduces medial meniscus extrusion associated with posterior root tears: One-year clinical outcomes. Knee Surg Sports Traumatol Arthrosc. 2025 Aug;33(8):2825-2832. doi: 10.1002/ksa.12533. Epub 2024 Nov 14.

    PMID: 39543774RESULT

  • Zhou Y, Yang Q, Kang J, Xu J, Chen M, Wu C. Clinical effect of medial meniscus posterior root repair combined with centralization technique in the treatment of medial meniscus posterior root tears. BMC Musculoskelet Disord. 2024 Nov 30;25(1):982. doi: 10.1186/s12891-024-08125-2.

    PMID: 39616323RESULT

Study Officials

  • Ahmet E Paksoy, Assoc.Prof.

    Ataturk University

    STUDY DIRECTOR

Central Study Contacts

Muhammet Celik, primary investigator, MD

CONTACT

905392087998drcelik@outlook.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 26, 2025

First Posted

April 2, 2025

Study Start

October 1, 2024

Primary Completion

January 1, 2026

Study Completion

February 1, 2026

Last Updated

May 4, 2025

Record last verified: 2025-04

Locations

TU(1)