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

NCT ID: NCT05370937

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-16
• Study Completion Date: 2023-04-16

Brief 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.

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

Conditions

Meniscus Tear; Meniscus Lesion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

ARTROSCOPİC SURGERY WITH ELEVATOR SYSTEM

Intervention Type: PROCEDURE

TRANSTİBİAL PULL OUT REPAİR FOR MEDİAL MENİSCUS POSTERİOR ROOT TEARS

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.

Group Type: ACTIVE_COMPARATOR

ARTROSCOPİC SURGERY WITHOUT ELEVATOR SYSTEM

Intervention Type: PROCEDURE

TRANSTİBİAL PULL OUT REPAİR FOR MEDİAL MENİSCUS POSTERİOR ROOT TEARS WITH ELEVATOR SYSTEM

Interventions

ARTROSCOPİC SURGERY WITH ELEVATOR SYSTEM

TRANSTİBİAL PULL OUT REPAİR FOR MEDİAL MENİSCUS POSTERİOR ROOT TEARS

Intervention Type: PROCEDURE

ARTROSCOPİC SURGERY WITHOUT ELEVATOR SYSTEM

TRANSTİBİAL PULL OUT REPAİR FOR MEDİAL MENİSCUS POSTERİOR ROOT TEARS WITH ELEVATOR SYSTEM

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ataturk University

OTHER

Sponsor Role: lead

Responsible Party

güneş sarıkaya

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

AHMET EMRE PAKSOY

Role: PRINCIPAL_INVESTIGATOR

Ataturk University

Locations

Atatürk University

Erzurum, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

31.03.2022

Identifier Type: -

Identifier Source: org_study_id