- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07408323
Arthroscopic Transtibial Pullout Suture Repair Versus Suture Anchor Repair in Posterior Root Tear of the Medial Meniscus
Arthroscopic Transtibial Pullout Suture Repair Versus Suture Anchor Repair in Posterior Root Tear of the Medial Meniscus: An Open-Label, Blinded-Endpoint, Randomized, Controlled Trial.
The menisci play a fundamental role in maintaining normal knee biomechanics by distributing load, absorbing shock, providing stability, and facilitating joint lubrication. Damage to the meniscus, particularly root tears, disrupts hoop tension and leads to altered joint loading patterns. This condition accelerates cartilage degeneration and predisposes patients to early-onset osteoarthritis, especially when untreated or inadequately managed.
Posterior root medial meniscus tears (PRMMTs) have gained increasing clinical attention in the past two decades. These injuries are biomechanically equivalent to a total meniscectomy because they cause extrusion of the meniscus and loss of its load- sharing capacity. PRMMTs typically affect middle-aged and older patients, often associated with degenerative changes, but can also occur in younger populations following trauma or high-impact activities.
The clinical presentation of PRMMTs is often subtle, with patients experiencing posterior knee pain, mechanical symptoms, and joint line tenderness. Magnetic resonance imaging (MRI) remains the gold standard for diagnosis, with characteristic findings such as the "ghost sign" and meniscal extrusion beyond 3 mm. However, diagnosis is frequently delayed, contributing to the progression of cartilage degeneration by the time of surgical intervention.
Several risk factors have been identified, including female gender, obesity, varus malalignment, and increased posterior tibial slope. These factors not only predispose patients to PRMMTs but also influence the prognosis following surgical repair. Given the high prevalence of these risk factors, especially in populations with rising obesity and osteoarthritis incidence, effective treatment strategies have become essential.
Surgical repair techniques have evolved significantly to restore hoop stresses and improve long-term outcomes. Two widely practiced arthroscopic methods are the transtibial pullout suture repair and the suture anchor repair. Both aim to reattach the meniscal root to its anatomical footprint, thereby restoring biomechanics and delaying degenerative progression.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Giza, Egypt
- Faculty of Medicine, for Girls, Al-Zhar University, Egpyt
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 20 and 50 years, both sexes.
- Acute or degenerative posterior root tear of the medial meniscus confirmed by MRI.
- Isolated medial meniscus root tear or tear associated with anterior cruciate ligament (ACL) injury.
- Willingness to participate and sign informed consent.
Exclusion Criteria:
- Refusal to participate.
- Knee joint malalignment (varus/valgus) confirmed clinically and radiologically.
- Osteoarthritis grade III or IV according to Kellgren-Lawrence classification.
- Irreparable or severely degenerated crushed meniscus.
- Prior ipsilateral knee fracture, infection, or tumor.
- Patients were deemed unfit for surgery or anesthesia.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arthroscopic Transtibial Pullout Suture Repair
|
Patients will have arthroscopic transtibial pullout for their Posterior Root Tear of the Medial Meniscus according to the description in the protocol
|
|
Active Comparator: Suture Anchor Repair
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patients will had this procedure according to the description in the protocol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
subjective functional improvement assessed via the Arabic validated form of the Lysholm score.
Time Frame: 1 year
|
The Lysholm score is a 100-point, patient-reported questionnaire evaluating knee ligament and meniscus injury, with higher scores indicating better function.
Score of 95-100 indicate excellent function, 84-94 indicate good function, 65-83 indicate fair function, while less than 65 indicates poor function
|
1 year
|
|
subjective functional improvement assessed via the Arabic validated form of the International Knee Documentation Committee 2000 score
Time Frame: 1 year
|
The International Knee Documentation Committee 2000 score is a 19-item patient-reported outcome measure scoring symptoms, activity, and function on a 0-100 scale.
Higher scores indicate better knee function and fewer symptoms.
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1971/4-7-2023
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Posterior Root Tear of the Medial Meniscus
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Orthox LimitedUniversity of Bristol; Avon Orthopaedic Centre, North Bristol NHS Trust, Bristol...TerminatedOther Tear of Medial Meniscus, Current InjuryUnited Kingdom
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Collegium Medicum w BydgoszczyCompletedKnee Injuries | Meniscus Lesion | Medial Meniscus TearPoland
-
Assiut UniversityCompletedMedial Meniscus, Posterior Horn DerangementEgypt
-
eMKa MED Medical CenterWroclaw Medical UniversityRecruitingMeniscus; Detachment, Current Injury | Detachment | Medial Mensical Tear | Medial Meniscus Knee InjuryPoland
-
First Affiliated Hospital of Ningbo UniversityThe First Affiliated Hospital of Xinxiang Medical CollegeEnrolling by invitationUnilateral Meniscus Tear of the Knee JointChina
-
Eskisehir Osmangazi UniversityThe Scientific and Technological Research Council of TurkeyRecruitingArthralgia | Knee Injuries | Meniscus; Degeneration | Knee Pain Swelling | Meniscus Lesion | Meniscus Tear | Knee; Injury, Meniscus (Lateral) (Medial) | Meniscus; Laceration | Meniscus Injury, TibialTurkey
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Maria-Josef-Hospital GrevenRecruitingMeniscus Lesion | Meniscal Tear | Meniscal Injuries | Partial Meniscal Loss | Lateral Meniscus Partial Loss | Medial Meniscal Partial LossGermany
-
University of Southern DenmarkOdense University Hospital; Aarhus University Hospital; Lundbeck Foundation; Aalborg... and other collaboratorsCompletedTear of Meniscus of KneeDenmark
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RTI SurgicalCompleted
Clinical Trials on Arthroscopic Transtibial Pullout Suture Repair
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Mayo ClinicEnrolling by invitation
-
Chuncheon Sacred Heart HospitalHallym UniversityCompletedRotator Cuff Tears
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Koray SahinCompletedRotator Cuff Injuries | Rotator Cuff TearsTurkey
-
Tartu University HospitalUniversity of TartuNot yet recruitingRotator Cuff Tears | Rotator Cuff Syndrome
-
Ataturk UniversityRecruitingMeniscus Injury | Meniscal ExtrusionTurkey
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Cairo UniversityCompletedPartial Thickness Articular-Side Rotator Cuff TearsEgypt
-
Pei-Yuan Lee, MDAeon Biotechnology CorporationUnknown
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Samsung Medical CenterUnknownSubscapularis Tendon Tear | Arthroscopic Repair | Arthroscopic DebridementKorea, Republic of
-
CM Chungmu HospitalCompletedRotator Cuff SyndromeKorea, Republic of
-
The Affiliated Hospital of Qingdao UniversityCompletedRotator Cuff TearsChina