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

Meniscus Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05370937
• Other study ID #: 31.03.2022
• Status: Completed
• Phase: N/A
• Start date: October 16, 2021
• Est. completion date: April 16, 2023

Study information

• Verified date: October 2023
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 16, 2023
• Est. primary completion date: March 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Meniscus Lesion
• Meniscus Tear

Intervention

Procedure:
• ARTROSCOPIC SURGERY WITH ELEVATOR SYSTEM
TRANSTIBIAL PULL OUT REPAIR FOR MEDIAL MENISCUS POSTERIOR ROOT TEARS
• ARTROSCOPIC SURGERY WITHOUT ELEVATOR SYSTEM
TRANSTIBIAL PULL OUT REPAIR FOR MEDIAL MENISCUS POSTERIOR ROOT TEARS WITH ELEVATOR SYSTEM

Locations

Country	Name	City	State
Turkey	Atatürk University	Erzurum

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Visual analoque score	(0-10, 0=no pain, 10=worst imaginable pain)	immediately before the surgery to 12-month post-operative period
Primary	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	meniscal extrusion on mri	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
Secondary	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
Secondary	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