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临床试验/NCT07408323
NCT07408323已完成不适用

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.

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年8月23日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
subjective functional improvement assessed via the Arabic validated form of the Lysholm score.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Arthroscopic Transtibial Pullout Suture Repair

Experimental

干预措施: Arthroscopic Transtibial Pullout Suture Repair (Procedure)

Suture Anchor Repair

Active Comparator

干预措施: Suture Anchor Repair (Procedure)

结局指标

主要结局

subjective functional improvement assessed via the Arabic validated form of the Lysholm score.

时间窗: 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

subjective functional improvement assessed via the Arabic validated form of the International Knee Documentation Committee 2000 score

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adham Tawfik

Principal Investigator

Al-Azhar University

研究点 (1)

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