NCT05370937

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 16, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 12, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2023

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

1.4 years

First QC Date

April 11, 2022

Last Update Submit

October 7, 2023

Conditions

Keywords

medial meniscus posterior root teartranstibial pullout system

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • meniscal extrusion on mrı

    immediately before the surgery to 12-month post-operative period

  • Kellgren Lawrence

    immediately before the surgery to 12-month post-operative period

  • Outer Bridge

    immediately before the surgery to 12-month post-operative period

Study Arms (2)

ELEVATOR

ACTIVE COMPARATOR

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

FREE KNOT

ACTIVE COMPARATOR

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

Interventions

TRANSTİBİAL PULL OUT REPAİR FOR MEDİAL MENİSCUS POSTERİOR ROOT TEARS

ELEVATOR

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

FREE KNOT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk University

Erzurum, 25000, Turkey (Türkiye)

Location

Study Officials

  • AHMET EMRE PAKSOY

    Ataturk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 11, 2022

First Posted

May 12, 2022

Study Start

October 16, 2021

Primary Completion

March 16, 2023

Study Completion

April 16, 2023

Last Updated

October 10, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

I will share this data when the work is complete

Locations