Seguridad y rendimiento de los anclajes de sutura MICRORAPTOR™ en hombro y cadera
Estudio de seguimiento clínico prospectivo multicéntrico posterior a la comercialización para evaluar la seguridad y el rendimiento de los anclajes de sutura MICRORAPTOR REGENESORB, REGENESORB sin nudos y PEEK sin nudos (y suturas MINITAPE) en la reparación de inestabilidad artroscópica de hombro y cadera
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- University of Colorado
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Colorado Springs, Colorado, Estados Unidos, 80920
- Colorado Springs Orthopaedic Group
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Florida
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Oakland Park, Florida, Estados Unidos, 33334
- Holy Cross Orthopedic Institute
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Georgia
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Brookhaven, Georgia, Estados Unidos, 30329
- Emory University - Brookhaven
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Maryland
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Annapolis, Maryland, Estados Unidos, 21401
- Luminis Health Research Institute
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Ohio
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Columbus, Ohio, Estados Unidos, 43202
- Ohio State University Wexner Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73114
- Oklahoma Sports and Science Orthopedics / The Physician's Group
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South Carolina
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Columbia, South Carolina, Estados Unidos, 29203
- Palmetto/Prisma Health - University of South Carolina Orthopaedics
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Greenville, South Carolina, Estados Unidos, 29615
- Steadman Hawkins Clinic of the Carolinas
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Virginia
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Virginia Beach, Virginia, Estados Unidos, 23452
- Atlantic Orthopaedic Specialists
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Woodbridge, Virginia, Estados Unidos, 22191
- Center for Advanced Orthopaedics / Nova Orthopedic & Spine Care
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Wisconsin
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Ashland, Wisconsin, Estados Unidos, 54806
- Memorial Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
El sujeto requiere la reinserción del tejido blando al hueso para las siguientes indicaciones:
- Hombro: estabilización capsular para reparación de Bankart, inestabilidad anterior del hombro, reparaciones de lesiones SLAP, reconstrucciones de desplazamiento capsular o capsulolabral, tenodesis del bíceps, reparaciones del manguito rotador (anclajes sin nudo solamente)
- Cadera - Reparación/reconstrucción del labrum acetabular
Descripción
Criterios de inclusión:
El sujeto requiere la reinserción del tejido blando al hueso para las siguientes indicaciones:
- Hombro: estabilización capsular para reparación de Bankart, inestabilidad anterior del hombro, reparaciones de lesiones SLAP, reconstrucciones de desplazamiento capsular o capsulolabral, tenodesis del bíceps, reparaciones del manguito rotador (anclajes sin nudo solamente)
- Cadera - Reparación/reconstrucción del labrum acetabular
- El sujeto ha dado su consentimiento para participar en el estudio mediante la firma del formulario de consentimiento informado aprobado por la CE.
- El sujeto tiene ≥18 años de edad en el momento de la cirugía.
- Dispuesto y capaz de hacer todas las visitas de estudio requeridas.
- Capaz de seguir instrucciones.
Criterio de exclusión:
- Hipersensibilidad conocida al material del implante. Cuando se sospeche sensibilidad del material, se deben realizar las pruebas adecuadas y descartar la sensibilidad antes de la implantación.
- Condiciones patológicas del hueso, como cambios quísticos u osteopenia severa, que comprometerían la fijación segura del anclaje.
- Condiciones patológicas en los tejidos blandos a unir que dificultarían la fijación segura por sutura.
- Superficie ósea conminuta, que comprometería la fijación segura del anclaje.
- Condiciones físicas que eliminarían, o tenderían a eliminar, el soporte de anclaje adecuado o retardarían la curación.
- La presencia de infección.
- Condiciones que limitarían la capacidad o voluntad del sujeto para restringir actividades o seguir instrucciones durante el período de curación.
- Actualmente usa productos de tabaco (cigarrillos, tabaco sin humo, cigarrillos electrónicos, vapeo, etc.).
- Cirugía bilateral concurrente.
- Implantación previa de MICRORAPTOR REGENESORB, MICRORAPTOR Knotless REGENESORB o MICRORAPTOR Knotless PEEK.
- Participación en el período de tratamiento de otro ensayo clínico dentro de los treinta (30) días de la Visita 1, o durante el estudio.
- Mujeres embarazadas o lactantes.
- Antecedentes de mala adherencia al tratamiento médico.
- Cirugías ipsilaterales previas realizadas en el espacio articular.
- Sujetos con una condición médica o física que, en opinión del investigador, impediría la participación segura de sujetos en el estudio.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Otro
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Anclaje de sutura MICRORAPTOR™ REGENESORB™
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El anclaje de sutura MICRORAPTOR™ REGENESORB™ de Smith & Nephew es un dispositivo de fijación diseñado para proporcionar una unión segura del tejido blando al hueso.
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Anclaje de sutura REGENESORB™ sin nudos MICRORAPTOR™
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El anclaje de sutura REGENESORB™ sin nudos MICRORAPTOR™ es un dispositivo de fijación que consiste en un anclaje en un insertador y un enhebrador de sutura.
El anclaje consta de los siguientes componentes: un cuerpo de anclaje proximal (REGENESORB™) y una punta de anclaje distal de PEEK (poliéter éter cetona) no absorbible.
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Anclaje de sutura de PEEK sin nudos MICRORAPTOR™
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El anclaje de sutura de PEEK sin nudos MICRORAPTOR™ es un dispositivo de clase IIb, que consta de un anclaje en un insertador y un enhebrador de sutura.
El anclaje consta de los siguientes componentes: un cuerpo de anclaje proximal (PEEK) y una punta de anclaje distal de PEEK no absorbible.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Repair Failure Rate at 6 Months
Periodo de tiempo: 6 months
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Repair failure at 6 months was determined by physician diagnosis of recurrent shoulder dislocation, subluxation, and patient symptoms (e.g., pain).
In the event of suspected repair failure, MRI or CT scan must confirm the root cause (i.e., intraarticular labrum failure or fixation repair failure) and assess glenoid bone loss.
The repair failure rate was defined as the number of participants with confirmed repair failure divided by the total number of participants in the study device group at the 6-month follow-up.
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6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Repair Failure Rate at 12 Months
Periodo de tiempo: 12 months
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Repair failure at 12 months was determined by physician diagnosis of recurrent shoulder dislocation, subluxation, and patient symptoms (e.g., pain).
In the event of suspected repair failure, MRI or CT scan must confirm the root cause (i.e., intraarticular labrum failure or fixation repair failure) and assess glenoid bone loss.
The repair failure rate was defined as the number of participants with confirmed repair failure divided by the total number of participants in the study device group at the 12-month follow-up.
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12 months
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Visual Analogue Scale (VAS) Pain Change From Baseline
Periodo de tiempo: Baseline to 6 months, 12 months, and 24 months
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Pain was assessed using a Visual Analogue Scale (VAS) where participants indicated their pain level by marking a point that represented their perceived pain intensity.
Scores ranged from 0 to 100, with 0 representing no pain and 100 representing the worst imaginable pain (i.e., a worse outcome).
A decrease in VAS Pain score indicated a reduction in pain (i.e., a better outcome) and an increase indicated worsening in pain (i.e., a worse outcome).
The mean change in pain score was recorded on the VAS from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group.
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Baseline to 6 months, 12 months, and 24 months
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Repair Failure Rate at 24 Months (MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor ONLY)
Periodo de tiempo: 24 months
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Repair failure at 24 months was collected only for participants that received the MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor.
Repair failure was determined by physician diagnosis of recurrent shoulder dislocation, subluxation, and patient symptoms (e.g., pain).
In the event of suspected repair failure, MRI or CT scan must confirm the root cause (i.e., intraarticular labrum failure or fixation repair failure) and assess glenoid bone loss.
The repair failure rate was defined as the number of participants with confirmed repair failure divided by the total number of participants in the study device group at the 24-month follow-up.
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24 months
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Anchor Absorption/Replacement by Bone (MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor ONLY): Acetabular Labral Condition
Periodo de tiempo: Baseline, 6 months, and 24 months
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Hip Magnetic Resonance Imagining (MRI) was performed on participants that received the MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor to determine anchor absorption/replacement by bone at baseline, 6 months, and 24 months based on acetabular labral condition classification. The number of participants acetabular labral condition was classified as one of the following:
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Baseline, 6 months, and 24 months
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Anchor Absorption/Replacement by Bone (MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor ONLY): Joint Effusion
Periodo de tiempo: Baseline, 6 months, and 24 months
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Hip Magnetic Resonance Imagining (MRI) was performed on participants that received the MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor to determine anchor absorption/replacement by bone at baseline, 6 months, and 24 months based on joint effusion classification. The number of participants joint effusion was classified as one of the following:
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Baseline, 6 months, and 24 months
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Anchor Absorption/Replacement by Bone (MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor ONLY): Bone Marrow Edema
Periodo de tiempo: Baseline, 6 months, and 24 months
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Hip Magnetic Resonance Imagining (MRI) was performed on participants that received the MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor to determine anchor absorption/replacement by bone at baseline, 6 months, and 24 months based on the presence of bone marrow edema.
The number of participants with bone marrow edema were categorized as 'Absent' or 'Present'.
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Baseline, 6 months, and 24 months
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Rowe Shoulder Score Change From Baseline (Shoulder Participants ONLY)
Periodo de tiempo: Baseline to 6 months, 12 months, and 24 months
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The Rowe shoulder score for shoulder instability evaluated using a 3-item instrument completed by the investigator or qualified, delegated study staff. Its questions addressed the categories of shoulder stability (0 to 50 points), motion (0 to 20 points), and function (0 to 30 points). Scores ranged from 0 to 100 with a score of 90-100 points indicating an excellent evaluation, 75-89 points indicating a good evaluation, 51-74 points indicating a fair evaluation, and =< 50 points indicating a poor evaluation. An increase in Rowe score indicated reduced shoulder instability (i.e., a better outcome) and a decrease indicated worsening instability (i.e., a worse outcome). The mean change in score was recorded from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group. |
Baseline to 6 months, 12 months, and 24 months
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Western Ontario Shoulder Instability Index (WOSI) Score Change From Baseline (Shoulder Participants ONLY)
Periodo de tiempo: Baseline to 6 months, 12 months, and 24 months
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Western Ontario Shoulder Instability Index (WOSI) was a participant completed instrument. Its categories included "physical symptoms", "sports, recreation, work", "pain", "lifestyle", and "emotion", with questions within each category scored from 0 to 100 using a visual analog scale. Scores were combined to produce an overall score that ranged from 0 to 2100 with a score of 0 indicating better shoulder function and 2100 indicating worse shoulder function. A decrease in WOSI score indicated improving shoulder function (i.e., a better outcome) and an increase indicated worsening shoulder function (i.e., a worse outcome). The mean change in score was recorded from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group. |
Baseline to 6 months, 12 months, and 24 months
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Constant-Murley Shoulder Scale Change From Baseline (Should Participants ONLY)
Periodo de tiempo: Baseline to 6 months, 12 months, and 24 months
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Constant-Murley Shoulder (CMS) scale assesses four aspects related to shoulder pathology: pain, activities of daily living (ADL), range of motion (ROM), and strength. The total score ranged from 0 to 100, with a higher score indicating better shoulder function. An increase in CMS score indicated improving shoulder function (i.e., a better outcome) and a decrease indicated worsening function (i.e., a worse outcome). The mean change in score was recorded from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group. |
Baseline to 6 months, 12 months, and 24 months
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Hip Outcome Score Activities of Daily Living (HOS-ADL) Score Change in Baseline (Hip Participants ONLY)
Periodo de tiempo: Baseline to 6 months, 12 months, and 24 months
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The Hip Outcome Score Activities of Daily Living (HOS-ADL) subscale consisted of 17 items that addressed specific activities related to hip function. Scores ranged from 0 to 100 with 0 representing the least function and 100 representing the most function. An increase in HOS-ADL score indicated improved hip function (i.e., a better outcome) and a decrease indicated worsening function (i.e., a worse outcome). The mean change in score was recorded from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group. |
Baseline to 6 months, 12 months, and 24 months
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Modified Harris Hip Score (mHHS) Change From Baseline (Hip Participants ONLY)
Periodo de tiempo: Baseline to 6 months, 12 months, and 24 months
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Modified Harris Hip Score (mHHS) is a joint specific score covering domains of pain, function, functional activities, absence of deformity, and hip range of motion. Scores ranged from 0 to 100, with 0 representing worse disability and 100 representing less disability. An increase in mHHS indicated improved hip joint function (i.e., a better outcome) and a decrease indicated worsening function (i.e., a worse outcome). The mean change in score was recorded from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group. |
Baseline to 6 months, 12 months, and 24 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Mary Ozokwere, Smith & Nephew, Inc.
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2018.20.SMD.MRPTKT.PRO
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.
producto fabricado y exportado desde los EE. UU.
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