CClinicalTrials.gg
CompletedNCT05370937Updated Oct 10, 2023

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

An interventional study of ARTROSCOPİC SURGERY WITH ELEVATOR SYSTEM and ARTROSCOPİC SURGERY WITHOUT ELEVATOR SYSTEM in Meniscus Tear and Meniscus Lesion, sponsored by Ataturk University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-10.

Sponsored by Ataturk University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Oct 2021, registered Apr 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Meniscus Tear
  • Meniscus Lesion

Keywords

  • medial meniscus posterior root tear
  • transtibial pullout system
03

In context

Lead sponsor

Ataturk University is the lead sponsor of 442 studies on the registry; 121 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
30 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • ProcedureARTROSCOPİC SURGERY WITH ELEVATOR SYSTEM

    TRANSTİBİAL PULL OUT REPAİR FOR MEDİAL MENİSCUS POSTERİOR ROOT TEARS

  • ProcedureARTROSCOPİC SURGERY WITHOUT ELEVATOR SYSTEM

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

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. Visual analoque score

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

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

  3. 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.

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

Secondary outcomes

  1. 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

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

  2. Kellgren Lawrence

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

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

  3. Outer Bridge

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

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

07

Study locations

1 site
  • Atatürk University
    Erzurum, 25000, Turkey
08

References and documents

Individual participant data

Plan to share: No — I will share this data when the work is complete

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05370937
Lead sponsor
Ataturk University
Responsible party
güneş sarıkaya (Principal investigator, Ataturk University) — Principal investigator
First posted
May 12, 2022
Start date
Oct 16, 2021
Primary completion
Mar 16, 2023
Completion
Apr 16, 2023
Last update
Oct 10, 2023

Study contacts

AHMET EMRE PAKSOY
principal investigator · Ataturk University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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