治験レーダーAI
治験 NCT07388290（対象：半月板断裂）は募集準備中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。
フィルター基準に一致する試験が1件見つかりました
タイル表示
検索に戻る

The Effect of Centralization on Medial Meniscal Extrusion for Medial Meniscus Posterior Root Tear Repair 54

募集準備中
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07388290 は 介入研究 臨床試験 で、半月板断裂 に関するものです。現在は 募集準備中 で、2026年3月1日 に開始予定です。54 名の参加者 の募集が計画されています。この試験は メイヨー・クリニック によって主導され、2030年3月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年2月5日 です。
概要
The purpose of this research is to determine if meniscus root repair with or without centralization will have an impact on postoperative pain, function, activity levels, patient satisfaction, and incidence of revision meniscus surgery.
公式タイトル

The Effect of Centralization on Medial Meniscal Extrusion for Medial Meniscus Posterior Root Tear Repair

疾患名
半月板断裂
その他の研究識別子
  • 25-011455
NCT番号
NCT07388290
開始日
2026-03
最終更新日
2026-02-05
終了予定日
2030-03
目標参加者数
54
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集準備中
キーワード
Meniscus tear
Meniscus extrusion
Medial meniscus root repair
Meniscus centralization
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
なし（非盲検）
群（アーム）／介入
参加グループ/群介入/治療法
実験的Repair with meniscus centralization
Medial meniscus posterior root tear (MMPRT) surgical repair with meniscus centralization
Medial meniscus posterior root tear (MMPRT) repair with meniscus centralization
The centralization technique involves placement of 1.8-mm Knotless FiberTak suture anchors along the periphery of the tibial plateau, starting from the posteromedial corner and progressing anteriorly. The anchors are deployed using a curved drill guide, and sutures are passed in a mattress configuration to re-tension the meniscotibial ligament to centralize the meniscus. Once centralization is complete, the posterio...もっと見る
実薬対照薬Repair without centralization
Medial meniscus posterior root tear (MMPRT) surgical repair without centralization
Medial meniscus posterior root tear (MMPRT) repair without meniscus centralization
The posterior root tear is repaired using an anatomic suture anchor for aperture medial meniscus root fixation.
主要評価項目
評価指標指標の説明時間枠
Meniscus extrusion measurement
Meniscus extrusion is measured in millimeters (mm) on coronal MRI at the level of the tibial spine
Baseline (Preoperatively), 6 months
副次評価項目
評価指標指標の説明時間枠
Change in Kellgren-Lawrence grade on X-ray
The Kellgren-Lawrence (KL) system is a 0-4 scale used to grade the severity of knee osteoarthritis (OA) based on X-ray. It ranges from Grade 0 (no changes) to Grade 4 (severe).
Baseline (Screening), 12 months, 24 months
Change in Tegner Activity Score
The Tegner Activity Questionnaire is a 1-item questionnaire rating physical activity from 0 (Disabled) to 10 (Elite competitive athlete). Total scores range from 0 - 10, with higher scores indicating a higher level of activity.
Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months
Change in Visual Analog Scale (VAS) Questionnaire score
The VAS is a 2-item questionnaire assessing pain using a scale of 0 (No pain) to 10 (Worst pain). Total scores range from 0 - 10, lower scores indicating lower pain and higher scores indicating greater pain.
Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months
Change in Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS, JR) Questionnaire score
The KOOS JR is a questionnaire designed to measure outcomes for patients with knee replacements. Questions focus on knee stiffness, pain, and function for daily activities and are assessed on a 5 point Likert-scale between 0 (None) and 4 (Extreme). Total scores range from 0 - 28, with higher scores indicating a greater impact of pain on daily functioning.
Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months
Change in International Knee Documentation Committee (IKDC) Questionnaire score
The International Knee Documentation Committee (IKDC) Subjective Knee Evaluation assesses overall function over 3 domains: symptoms, athletic activity, and knee function. Higher scores indicate higher levels of function and lower levels of symptoms.
Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months
Change in Likert Knee Questionnaire score
The Likert Knee Questionnaire is a 1-item survey asking the patient to rate knee pain post-surgery on a Likert scale where 0 (Much better than before surgery) and 5 (Much worse than before surgery).
Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months
Surgery Satisfaction Questionnaire
The Surgery Satisfaction Questionnaire is a 1-item survey asking the patient to rate satisfaction with knee surgery on a Likert scale where 0 (Not at all) and 10 (Most Satisfied).
2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months
参加アシスタント
適格基準

対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
  • Type 2 Medial Meniscus Posterior Root Tear demonstrated on MRI
  • Notable extrusion (>3 mm) on preoperative MRI
  • Patient able to consent for themselves
  • Patient agrees to comply with trial schedules and plan

Pre-operative Exclusion:

  • Concomitant ligamentous or meniscal procedures
  • Meniscal extrusion > 6 mm on pre-operative MRI
  • Kellgren-Lawrence grade > 2
  • Varus malalignment > 10 degrees
  • Asymmetric varus alignment > 5 degrees
  • Varus thrust while weightbearing
  • Grade 3 bipolar medial compartment changes (isolated grade 3 changes on single articular surface with ≤ grade 2 changes on the opposing surface remains eligible)
  • Previous surgery of the affected knee
  • Associated fractures requiring surgery
  • Concurrent Vascular injuries
  • Hypermobility/Ehlers-Danlos Syndrome
  • Inflammatory or autoimmune disease
  • Severe mental/physical disability precluding post operative rehabilitation demands
  • Contraindications to MRI
  • Pregnant women

Arthroscopy Inclusion Criteria:

  • Complete radial tears within 9 mm of medial meniscus posterior root
  • ICRS Grade 3 or better

  • Requiring concomitant procedures other than MMPRT
  • ICRS Grade 4 changes
Mayo Clinic logoメイヨー・クリニック
責任者
Aaron Krych, 主任研究者, Principal Investigator, Mayo Clinic
試験中央連絡先
連絡先: Sejal Dave, 507-266-9085, [email protected]
3 1カ国の場所

Colorado

The Steadman Clinic, West Vail, Colorado, 81657, United States

Florida

Hospital for Special Surgery at Naples Comprehensive Health (HSS at NCH),, Naples, Florida, 34110, United States

Minnesota

Mayo Clinic, Rochester, Minnesota, 55902, United States