Étude de suivi clinique post-commercialisation JuggerStitch
JuggerStitch™ pour la réparation méniscale Étude de suivi clinique post-commercialisation
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).
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Magdeburg, Allemagne, 39120
- Medizinische Fakultät der Otto-von-Guericke-Universität Magdeburg
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Lyon, France, 69008
- Ramsay General de Sante - Hôpital Privé Jean Mermoz - Centre Orthopédique Santy
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Tokyo, Japon, 113-8519
- Tokyo Medical and Dental University Hospital of Medicine
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Ibaraki
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Tsukuba, Ibaraki, Japon, 300-3295
- Ichihara Hospital
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North Carolina
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Charlotte, North Carolina, États-Unis, 28207
- OrthoCarolina
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Virginia
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Richmond, Virginia, États-Unis, 23226
- OrthoVirginia, Inc.
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Meniscal repair
Patients in need of meniscal repair |
Treatment of torn meniscus with JuggerStitch. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Clinical Success
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Number of Adverse Events
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Kim Blick, Zimmer Biomet
- Chaise d'étude: Nesma Bayrich, DDS, Zimmer Biomet
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CMG2017-14SM
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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