Clınıcal Results of Evelator and Free Knot Methods In Medial Menıscus Posterior Root Tears
1 other identifier
interventional
30
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 16, 2021
CompletedFirst Submitted
Initial submission to the registry
April 11, 2022
CompletedFirst Posted
Study publicly available on registry
May 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 16, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 16, 2023
CompletedOctober 10, 2023
October 1, 2023
1.4 years
April 11, 2022
October 7, 2023
Conditions
Keywords
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 COMPARATORAfter 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
FREE KNOT
ACTIVE COMPARATORThe 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.
Interventions
TRANSTİBİAL PULL OUT REPAİR FOR MEDİAL MENİSCUS POSTERİOR ROOT TEARS
TRANSTİBİAL PULL OUT REPAİR FOR MEDİAL MENİSCUS POSTERİOR ROOT TEARS WITH ELEVATOR SYSTEM
Eligibility Criteria
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)
Study Officials
- PRINCIPAL INVESTIGATOR
AHMET EMRE PAKSOY
Ataturk University
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