Estudio de seguimiento clínico posterior a la comercialización de JuggerStitch
JuggerStitch™ para reparación de meniscos Estudio de seguimiento clínico posterior a la comercialización
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).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Magdeburg, Alemania, 39120
- Medizinische Fakultät der Otto-von-Guericke-Universität Magdeburg
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28207
- OrthoCarolina
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Virginia
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Richmond, Virginia, Estados Unidos, 23226
- OrthoVirginia, Inc.
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Lyon, Francia, 69008
- Ramsay General de Sante - Hôpital Privé Jean Mermoz - Centre Orthopédique Santy
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Tokyo, Japón, 113-8519
- Tokyo Medical and Dental University Hospital of Medicine
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Ibaraki
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Tsukuba, Ibaraki, Japón, 300-3295
- Ichihara Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Meniscal repair
Patients in need of meniscal repair |
Treatment of torn meniscus with JuggerStitch. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Clinical Success
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Adverse Events
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Kim Blick, Zimmer Biomet
- Silla de estudio: Nesma Bayrich, DDS, Zimmer Biomet
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CMG2017-14SM
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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