Clınıcal Results of Evelator and Free Knot Methods In Medial Menıscus Posterior Root Tears

In this thesis study, the transtibial pullout method, which is one of the treatment methods for medial meniscus posterior root tear, will be used in patients over the age of 18 with medial meniscus posterior root tear, who applied to the Atatürk University Orthopedics and Traumatology clinic. The patients will be divided into two groups. In the first group, after knotting the posterior root of the medial meniscus with a fiber rope, a tunnel will be opened for the rope to pass through the medial of the proximal crest of the tibia. Then, arthroscopically, the rope will be taken through the joint and passed through the tunnel, and the knot will be fixed to the tibia by using the endobutton elevator system. In the second group, the first stage of fixation is the same, and fixation to the tibia will be done with an endobutton by tying a free knot without using an elevator system. The clinical and radiological scores of both groups just before the operation and at the twelve months after the operation will be calculated and their relationship with each other will be examined.

Study Overview

• Status: Completed
• Conditions: Meniscus Lesion; Meniscus Tear
• Intervention / Treatment: Procedure: ARTROSCOPİC SURGERY WITH ELEVATOR SYSTEM; Procedure: ARTROSCOPİC SURGERY WITHOUT ELEVATOR SYSTEM

Detailed Description

This thesis study is planned as a prospective study and approximately 30 patients with medial meniscus posterior root tear over the age of 18 who will apply to Erzurum Atatürk University Research Hospital Orthopedics and Traumatology clinic are planned to participate in this study. Based on a study by Yuki et al. (reference 3), the difference in the Lysholm score in the first group, which will be fixed with the elevator system, in the preoperative and postoperative sixth month was 33± 10 units, and in the second group, the difference in the preoperative and postoperative sixth month was 20± 14 units to be statistically significant, it was calculated with the G*POWER 3.1.9.4 program that 15 patients from each group should be taken at 80% power and 95% confidence level, a total of 30 patients. Patients will be divided into two groups of 15 people each. The endobutton elevator system will be used in the tibial fixation of the first group. In the tibial fixation of the second group, the endobutton free knot technique will be used. Demographic information of the patients will be recorded. Vas score, Lysholm score and Kellgren-lawrance classification will be made for the patients in these two groups, according to the results of the outpatient clinic control just before the operation and at the twelve months after the operation. This will be done by a physician who is in our entire follow-up clinic and does not go into the surgery of the patients. The clinical scores and radiological degenerative changes of these two groups just before the operation and at the twelve months after the operation will be examined

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Erzurum, Turkey, 25000
    • Ataturk University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. older than 18 years
2. Findings showing medial meniscus root repair indication in the MRI with Outer-Bridge grade 1 or 2 and Kellegren Lawrence grade 0-2

Exclusion Criteria:

1. Patients with chronic knee pain and chronic use of NSAIDs or opioids
2. Patients with chronic instability and anterior cruciate ligament damage in addition to medial meniscus root tear
3. Patients who had meniscus root repair before, but did not get good results and went for revision
4. Patients who underwent tibial osteotomy with meniscus root repair.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ELEVATOR; After knotting the posterior root of the medial meniscus with a fiber rope, a tunnel will be opened for the rope to pass through the medial of the proximal crest of the tibia. Then, arthroscopically, the rope will be taken through the joint and passed through the tunnel, and the knot will be fixed to the tibia by using the endobutton elevator system	Procedure: ARTROSCOPİC SURGERY WITH ELEVATOR SYSTEM; TRANSTİBİAL PULL OUT REPAİR FOR MEDİAL MENİSCUS POSTERİOR ROOT TEARS
Active Comparator: FREE KNOT; The first stage of fixation is the same, and fixation to the tibia will be done with an endobutton by tying a free knot without using an elevator system.	Procedure: ARTROSCOPİC SURGERY WITHOUT ELEVATOR SYSTEM; TRANSTİBİAL PULL OUT REPAİR FOR MEDİAL MENİSCUS POSTERİOR ROOT TEARS WITH ELEVATOR SYSTEM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lysholm score	0-100-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.	immediately before the surgery to 12-month post-operative period
Visual analoque score	(0-10, 0=no pain, 10=worst imaginable pain)	immediately before the surgery to 12-month post-operative period
Tegner Activity Score	The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.	immediately before the surgery to 12-month post-operative period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
meniscal extrusion on mrı	Meniscal extrusion is generally defined as significant (≥3 mm) medial displacement of the meniscus with respect to the central margin of the tibial plateaurecording the preop and postop meniscal extusion	immediately before the surgery to 12-month post-operative period
Kellgren Lawrence	The Kellgren and Lawrence system is a common method of classifying the severity of osteoarthritis (OA) using five grades	immediately before the surgery to 12-month post-operative period
Outer Bridge	Outer Bridge classification is a grading system for joint cartilage breakdown.grade: 0 normal-grade 4 - more cartilage damage	immediately before the surgery to 12-month post-operative period

Collaborators and Investigators

• Sponsor: Ataturk University
• Investigators: Principal Investigator: AHMET EMRE PAKSOY, Ataturk University

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2021
• Primary Completion (Actual): March 16, 2023
• Study Completion (Actual): April 16, 2023

Study Registration Dates

• First Submitted: April 11, 2022
• First Submitted That Met QC Criteria: May 7, 2022
• First Posted (Actual): May 12, 2022

Study Record Updates

• Last Update Posted (Estimated): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 7, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: medial meniscus posterior root tear; transtibial pullout system
• Other Study ID Numbers: 31.03.2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: I will share this data when the work is complete

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No