JuggerStitch の市販後臨床追跡調査
半月板修復用 JuggerStitch™ 市販後の臨床フォローアップ研究
This study is a post-market follow-up study. The data collected from this study will serve the purpose of confirming the safety and performance of the JuggerStitch Device used for meniscal repair according to the product labelling (Instruction For Use).
調査の概要
詳細な説明
This study is a post-market follow-up study to fulfil the post-market surveillance obligations according to Medical Device Directive and MEDDEV 2.12/2 and the Medical Devices Regulation (MDR 2017/745). The data collected from this study will serve the purpose of confirming the safety and performance of the JuggerStitch Device used for meniscal repair according to the product labelling (IFU).
The objectives of the study are to calculate the overall clinical success rate and the performance, and confirm the safety of the JuggerStitch Meniscal Repair Device. The primary endpoint of this study is defined by the absence of reoperation due to meniscal tear. This will be measured against the success criteria of the absence of reoperation in 90.2% of the cases at one year.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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North Carolina
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Charlotte、North Carolina、アメリカ、28207
- OrthoCarolina
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Virginia
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Richmond、Virginia、アメリカ、23226
- OrthoVirginia, Inc.
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Magdeburg、ドイツ、39120
- Medizinische Fakultät der Otto-von-Guericke-Universität Magdeburg
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Lyon、フランス、69008
- Ramsay General de Sante - Hôpital Privé Jean Mermoz - Centre Orthopédique Santy
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Tokyo、日本、113-8519
- Tokyo Medical and Dental University Hospital of Medicine
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Ibaraki
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Tsukuba、Ibaraki、日本、300-3295
- Ichihara Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Subject qualifies for meniscal repair based on the physical exam and medical history and meets the approved indications for use of the study product;
- Older than 18 years and skeletally mature;
- Willing and able to comply with the study procedures;
- Subject is capable of understanding the doctor's explanations, following his instructions and is able to participate in the follow-up program;
- Subject is able to read and understand the informed consent form (ICF) and has voluntarily provided written informed consent.
Exclusion Criteria:
- Meniscal tears in the avascular zone of meniscus;
- Meniscal tears not suitable for repair because of the degree of damage(marked irregularity and complex tearing) to the meniscus body including degenerative, radial, horizontal cleavage and flap tears;
- Presence of active infection;
- If female, subject is pregnant;
- Subject is vulnerable (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant);
- The subject is unwilling or unable to give consent or to comply with the follow-up program;
- Subject meets any contraindications of the appropriate Instruction for Use.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Meniscal repair
Patients in need of meniscal repair |
Treatment of torn meniscus with JuggerStitch. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Clinical Success
時間枠：From the date of surgery through the participant's last available follow-up; minimum follow-up of 1 year and mean follow-up of 3.2 years
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The absence of reoperation due to meniscal tear. This will be measured against the success criteria of the absence of reoperation in 90.2% of the cases at 1 year. Clinical success was defined as the absence of reoperation of the index knee due to a meniscal tear from the date of surgery through the participant's last available follow-up. All participants included in the analysis had at least 1 year of follow-up, and follow-up beyond 1 year was included when available. |
From the date of surgery through the participant's last available follow-up; minimum follow-up of 1 year and mean follow-up of 3.2 years
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of Adverse Events
時間枠：From the date of surgery through the participant's last available follow-up; minimum follow-up of 1 year and mean follow-up of 3.2 years
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The total number of adverse events reported from the date of surgery through each participant's last available follow-up was assessed to evaluate the safety of the JuggerStitch Meniscal Repair Device. Events were included regardless of seriousness or assessed relationship to the device, instrumentation, or procedure. |
From the date of surgery through the participant's last available follow-up; minimum follow-up of 1 year and mean follow-up of 3.2 years
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Lysholm Knee Scoring Scale Score
時間枠：Pre-operatively, 6 weeks, 6 months and 1 year post-surgery
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The Lysholm Knee Scoring Scale assesses knee symptoms and function based on pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. The total score ranges from 0 to 100, with higher scores indicating better knee function and fewer symptoms. |
Pre-operatively, 6 weeks, 6 months and 1 year post-surgery
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Tegner Activity Scale Score
時間枠：Preoperatively and at 6 weeks, 6 months, and 1 year postoperatively
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The Tegner Activity Scale assesses participation in work and sports activities. Scores range from 0 to 10, where 0 indicates sick leave or disability because of knee problems and 10 indicates participation in competitive elite sports. Higher scores indicate a higher level of physical activity. |
Preoperatively and at 6 weeks, 6 months, and 1 year postoperatively
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International Knee Documentation Committee Subjective Knee Evaluation Form Score
時間枠：Preoperatively and at 6 weeks, 6 months, and 1 year postoperatively
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The International Knee Documentation Committee Subjective Knee Evaluation Form assesses knee symptoms, function, and ability to participate in sports activities. The total score ranges from 0 to 100, with higher scores indicating fewer symptoms, better knee function, and a better outcome. |
Preoperatively and at 6 weeks, 6 months, and 1 year postoperatively
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Number of Participants by Joint Line Tenderness Test Result
時間枠：Preoperatively and at 6 weeks, 6 months, and 1 year postoperatively
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The Joint Line Tenderness Test was performed during clinical examination by palpating the medial and lateral joint lines of the operated knee. The test was considered positive when palpation elicited joint line pain or tenderness and negative when no joint line pain or tenderness was elicited. Results are reported as the number of participants with positive and negative findings at each assessment. |
Preoperatively and at 6 weeks, 6 months, and 1 year postoperatively
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Number of Participants by McMurray Test Result
時間枠：Preoperatively and at 6 weeks, 6 months, and 1 year postoperatively
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The McMurray Test was performed during the clinical examination of the operated knee using knee flexion and extension with tibial rotation and applied varus or valgus stress. The test was considered positive when pain, snapping, an audible or palpable click, or locking suggestive of meniscal pathology was elicited. The test was considered negative when none of these findings was present. Results are reported as the number of participants with positive and negative test findings at each assessment. |
Preoperatively and at 6 weeks, 6 months, and 1 year postoperatively
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協力者と研究者
スポンサー
捜査官
- スタディチェア：Kim Blick、Zimmer Biomet
- スタディチェア：Nesma Bayrich, DDS、Zimmer Biomet
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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