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Completed

NCT Number: NCT05370937

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.

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Key information

Conditions

Meniscus Tear Meniscus Lesion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atatürk University

Erzurum, 25000, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • older than 18 years
  • 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

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

Treatment and study plan

ARTROSCOPİC SURGERY WITH ELEVATOR SYSTEM

Procedure

TRANSTİBİAL PULL OUT REPAİR FOR MEDİAL MENİSCUS POSTERİOR ROOT TEARS

ARTROSCOPİC SURGERY WITHOUT ELEVATOR SYSTEM

Procedure

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

Primary outcomes

  1. Lysholm score

    Time frame: immediately before the surgery to 12-month post-operative period

    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.

  2. Visual analoque score

    Time frame: immediately before the surgery to 12-month post-operative period

    (0-10, 0=no pain, 10=worst imaginable pain)

  3. Tegner Activity Score

    Time frame: immediately before the surgery to 12-month post-operative period

    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.

Secondary outcomes

  1. meniscal extrusion on mrı

    Time frame: immediately before the surgery to 12-month post-operative period

    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

  2. Kellgren Lawrence

    Time frame: immediately before the surgery to 12-month post-operative period

    The Kellgren and Lawrence system is a common method of classifying the severity of osteoarthritis (OA) using five grades

  3. Outer Bridge

    Time frame: immediately before the surgery to 12-month post-operative period

    Outer Bridge classification is a grading system for joint cartilage breakdown.grade: 0 normal-grade 4 - more cartilage damage

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 12, 2022
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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