Meniscus TearNCT05370937
Clınıcal Results of Evelator and Free Knot Methods In Medial Menıscus Posterior Root Tears
A study testing ARTROSCOPİC SURGERY WITH ELEVATOR SYSTEM and ARTROSCOPİC SURGERY WITHOUT ELEVATOR SYSTEM in people with Meniscus Tear and Meniscus Lesion, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meniscus Tear, Meniscus Lesion
- What is being tested?
- ARTROSCOPİC SURGERY WITH ELEVATOR SYSTEM and ARTROSCOPİC SURGERY WITHOUT ELEVATOR SYSTEM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Oct 2021to 16 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Meniscus Tear, Meniscus Lesion
- Being tested
- ARTROSCOPİC SURGERY WITH ELEVATOR SYSTEM, ARTROSCOPİC SURGERY WITHOUT ELEVATOR SYSTEM
- Keywords
- medial meniscus posterior root tear, transtibial pullout system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARTROSCOPİC SURGERY WITH ELEVATOR SYSTEMProcedure or surgery
TRANSTİBİAL PULL OUT REPAİR FOR MEDİAL MENİSCUS POSTERİOR ROOT TEARS
ARTROSCOPİC SURGERY WITHOUT ELEVATOR SYSTEMProcedure or surgery
TRANSTİBİAL PULL OUT REPAİR FOR MEDİAL MENİSCUS POSTERİOR ROOT TEARS WITH ELEVATOR SYSTEM
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Procedure: ARTROSCOPİC SURGERY WITHOUT ELEVATOR SYSTEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediately before the surgery to 12-month post-operative period
Visual analoque score
(0-10, 0=no pain, 10=worst imaginable pain)
Measured: 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.
Measured: immediately before the surgery to 12-month post-operative period
Secondary outcomes (3)
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
Measured: immediately before the surgery to 12-month post-operative period
Kellgren Lawrence
The Kellgren and Lawrence system is a common method of classifying the severity of osteoarthritis (OA) using five grades
Measured: immediately before the surgery to 12-month post-operative period
Outer Bridge
Outer Bridge classification is a grading system for joint cartilage breakdown.grade: 0 normal-grade 4 - more cartilage damage
Measured: immediately before the surgery to 12-month post-operative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start16 Oct 2021
- Primary completion16 Mar 2023
- Study completion16 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscus TearStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, güneş sarıkaya, Ataturk University
- Investigators
- AHMET EMRE PAKSOY, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370937
- Sponsor's protocol ID
- 31.03.2022
- Status last verified
- Oct 2023
- First submitted
- 11 Apr 2022
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I will share this data when the work is complete
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clınıcal Results of Evelator and Free Knot Methods In Medial Menıscus Posterior Root Tears
- ClinicalTrials.gov ID
- NCT05370937
- Acronym / sponsor ID
- 31.03.2022
- Conditions
- Meniscus Tear, Meniscus Lesion
- Keywords
- medial meniscus posterior root tear, transtibial pullout system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 16 Oct 2021 (actual)
- Primary completion
- 16 Mar 2023 (actual)
- Study completion
- 16 Apr 2023 (actual)
- First posted
- 12 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ELEVATOR | Active comparator | Procedure: ARTROSCOPİC SURGERY WITH ELEVATOR SYSTEMAfter 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 comparator | Procedure: ARTROSCOPİC SURGERY WITHOUT ELEVATOR SYSTEMThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARTROSCOPİC SURGERY WITH ELEVATOR SYSTEMTRANSTİBİAL PULL OUT REPAİR FOR MEDİAL MENİSCUS POSTERİOR ROOT TEARS | Procedure or surgery | ELEVATOR |
| ARTROSCOPİC SURGERY WITHOUT ELEVATOR SYSTEMTRANSTİBİAL PULL OUT REPAİR FOR MEDİAL MENİSCUS POSTERİOR ROOT TEARS WITH ELEVATOR SYSTEM | Procedure or surgery | FREE KNOT |
Primary outcome
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.
Visual analoque score
Time frame: immediately before the surgery to 12-month post-operative period
(0-10, 0=no pain, 10=worst imaginable pain)
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.
3 secondary outcomes
meniscal extrusion on mrı
Time frame: immediately before the surgery to 12-month post-operative period
Kellgren Lawrence
Time frame: immediately before the surgery to 12-month post-operative period
Outer Bridge
Time frame: immediately before the surgery to 12-month post-operative period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: No. I will share this data when the work is complete
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AHMET EMRE PAKSOY principal investigator
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARTROSCOPİC SURGERY WITH ELEVATOR SYSTEM and ARTROSCOPİC SURGERY WITHOUT ELEVATOR SYSTEM in people with Meniscus Tear and Meniscus Lesion, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lysholm score (time frame: immediately before the surgery to 12-month post-operative period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.