- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06906783
Transtibial Pull Out Method Versus Suture Anchor Method for Meniscus Extrusion
Comparison of Transtibial Pull Out Method And Suture Anchor Method in Surgical Treatment of Meniscus Extrusion
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Muhammet Celik, primary investigator, MD
- Phone Number: 905392087998
- Email: drcelik@outlook.com
Study Locations
-
-
Yakutiye
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Erzurum, Yakutiye, Turkey, 25100
- Recruiting
- Ataturk University Hospital
-
Contact:
- Muhammet Celik, Principal Investigator, MD
- Phone Number: 905392087998
- Email: drcelik@outlook.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Presence of meniscal extrusion greater than 3 mm on MRI scans
- Symptomatic complaints in the knee with extrusion
Exclusion Criteria:
- Malalignment greater than 5 degrees
- Presence of Kellgren-Lawrence grade 3-4 osteoarthritis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Transtibial Pull Out Method
|
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.
|
|
Active Comparator: Suture Anchor Method
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the amount of meniscus extrusion in MR images.
Time Frame: From enrollment to the end of treatment at 12 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lysholm score
Time Frame: From enrollment to the end of treatment at 3, 6 and 12 months.
|
The Lysholm score is a 100-point scoring system for examining a patient's knee-specific symptoms including mechanical locking, instability, pain, swelling, stair climbing, and squatting.
|
From enrollment to the end of treatment at 3, 6 and 12 months.
|
|
Tegner activity score
Time Frame: From enrollment to the end of treatment at 3, 6 and 12 months.
|
The scale is numbered on a "0-10" format, with 10 being international soccer, and one being a person who is disabled from knee issues.
|
From enrollment to the end of treatment at 3, 6 and 12 months.
|
|
International Knee Documentation Committee (IKDC) Score
Time Frame: From enrollment to the end of treatment at 3, 6 and 12 months.
|
The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items).
Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
|
From enrollment to the end of treatment at 3, 6 and 12 months.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ahmet E Paksoy, Assoc.Prof., Ataturk University
Publications and helpful links
General Publications
- 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 menicus extrusion associated with posterior root tears: One-year clinical outcomes. Knee Surg Sports Traumatol Arthrosc. 2024 Nov 14. doi: 10.1002/ksa.12533. Online ahead of print.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ATAUNIORTHO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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