Sistema de Hombro Sin Vástago OsseoFit (Anatómico)
Estudio de Seguimiento Clínico Postcomercialización del Sistema de Hombro Sin Vástago OsseoFit (Anatómico)
The purpose of this clinical research protocol is to evaluate the safety, efficacy, and long-term outcomes of the OsseoFit Stemless Shoulder System (Anatomic) in patients with a primary diagnosis of osteoarthritis. The study aims to assess the intraoperative characteristics, postoperative complications, functional outcomes, and radiographic findings associated with the use of the stemless implant system. Ultimately, this research aims to improve patient outcomes, enhance surgical techniques, and inform clinical decision-making in the treatment of shoulder pathology.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The objectives of this study are to confirm the safety, performance, and clinical benefits of the OsseoFit Stemless Shoulder System (implants and instruments) in primary total shoulder arthroplasty (anatomic). Safety of the system will be assessed by monitoring the frequency and incidence of adverse events. The performance and clinical benefits will be evaluated by assessment of the overall pain and functional performance, survivorship, quality of life, and radiographic parameters for all enrolled study participants.
The primary endpoint is the improvement in the American Shoulder and Elbow Surgeons (ASES) Shoulder score between the pre-operative period (baseline) and 2 years of follow up.
The key secondary endpoint is the survival of the implant system at 10 years, which is based on removal of any part of the study device and will be determined using Kaplan Meier method.
The safety of the system will be assessed by monitoring the frequency and incidence of adverse events.
The secondary endpoint evaluation will also assess the overall pain/functional performance (ASES, Constant Murley Shoulder Score, and ROM), quality of life, satisfaction, and radiographic parameters of all enrolled study participants.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
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New Jersey
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Florham Park, New Jersey, Estados Unidos, 07932
- Summit Medical Group P.A. dba Summit
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New York
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Buffalo, New York, Estados Unidos, 14228
- The Research Foundation for the State University of New York
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
The OsseoFit Stemless Shoulder implants are intended for shoulder joint arthroplasty. OsseoFit™ Stemless Shoulder humeral components have a porous surface and are indicated for uncemented biological fixation applications.
Compatible Glenoid components are intended to be implanted with bone cement. The porous posts may be inserted without bone cement.
Compatible Comprehensive Convertible Glenoid components are intended for cementless applications with the addition of screw fixation.
Descripción
Inclusion Criteria:
- Patient must be 20 years of age or older.
- The patient must be anatomically and structurally suited, as evident by scapula and proximal humerus closure, to receive the implants.
- Patient planned to receive OsseoFit™ anchor with uncemented fixation.
- Patient planned to receive a Modular Alliance Glenoid with bone cement. The porous posts must be coated with Porous Plasma Spray (PPS) and may be inserted without bone cement.
- Patient planned to receive shoulder arthroplasty due to osteoarthritis.
- Patient must be able and willing to complete the protocol required follow-up schedule.
- Patient must be able and willing to sign the IRB approved consent.
Exclusion Criteria:
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Patient is unwilling or unable to give consent or to comply with the follow-up program.
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Patient has any condition which would in the judgement of the Investigator, place the patient at undue risk or interfere with the study.
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Patient is known to be pregnant or breastfeeding.
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Patient is a vulnerable participant (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, and/or anticipated to be non-compliant).
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Patient is uncooperative or patient with neurologic disorders who is incapable or unwilling to follow directions.
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Patient has any neuromuscular disease compromising the affected limb.
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Patient has any sign of infection affecting the shoulder joint or in its proximity which may spread to the implant site. This may include:
- Local/systemic infection
- Sepsis
- Osteomyelitis
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Patient presents with Osteomalacia.
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Patient presents with a humeral bone fracture.
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Patient presents with malunion or non-union of the tuberosities of the proximal humerus.
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Patient has had a previous operative shoulder prosthesis (stem or stemless).
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Patient has irreparable cuff tear.
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Patient presents with inadequate humeral bone, which in the opinion of the Investigator, may lead to poor implant fixation. This may include but is not limited to:
- Osteoporosis
- Extensive Avascular Necrosis
- Rheumatoid Arthritis
- Metaphyseal bony defects (including large cysts)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
OsseoFit Stemless Inlay
Subjects who were implanted with the Inlay variant of the Osseofit Stemless Shoulder System. |
Inlay implants have a dished superior portion with a shorter fin length to allow the implant to sit within the bone. |
|
OsseoFit Stemless Onlay
Subjects who were implanted with the Onlay variant of the Osseofit Stemless Shoulder System. |
The Onlay implants sit on top of the prepared bone. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
the American Shoulder and Elbow Surgeons (ASES) Shoulder Score
Periodo de tiempo: 2 years
|
The primary endpoint is the American Shoulder and Elbow Surgeons (ASES) Shoulder Score. Improvement from baseline to 2 years will be evaluated using the overall mean change, with effectiveness demonstrated if the mean improvement exceeds the MCID of 10.8 points. The primary endpoint analysis will use the ITT population with all available data and no imputation. Hypotheses: H0: μCFB ≤ 10.8; H1: μCFB > 10.8, where μCFB is the mean ASES change (2 years minus baseline). The MCID of 10.8 was established using the 0.5 SD distribution method based on psychometric evaluation of ASES scores from 3,667 shoulder arthroplasty patients with ≥2-year follow-up. |
2 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Implant Survival
Periodo de tiempo: 10 Years
|
Based on removal of any part of the study device and will be determined using Kaplan Meier method. |
10 Years
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ASES
Periodo de tiempo: 6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
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The American Shoulder and Elbow Surgeons Shoulder Score (ASES) was designed to assess the condition of the shoulder, regardless of disease pathology. It consists of two equally weighted components: pain (50 points) and function/disability (50 points). The pain sub-score is calculated from a single question VAS tool. The function/disability sub-score is calculated from a 10 question, 4-point Likert scale. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition. |
6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
|
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Constant Murley
Periodo de tiempo: 6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
|
The Constant-Murley score (CMS) is a patient-reported outcome questionnaire that comprises outcome measures of freedom from pain (15 points), full range of function (20 points), active range of movement (40 points), and full strength (25 points). The total score is an aggregate of the individual outcome measures. The minimum score is 0 (worst outcome) and the maximum score possible is 100 points (best outcome). |
6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
|
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EQ-5D-5L composite
Periodo de tiempo: 6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
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The EQ-5D is a standardized instrument widely used to measure health status. It is a self-reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS). The questionnaire includes 5 questions referring to mobility, self-care, daily/usual activities, pain/discomfort and anxiety/depression. For EQ-5D-5L, each question can be answered in five ways, indicating no, slight, moderate, severe or extreme pain. In the derived EQ-5D-5L score, the highest score is 1 and the lowest score is -0.573. Negative numbers correspond to a self-assessed health state worse than being dead. The VAS is a vertical scale ranging from 0 ('The worst health you can imagine') to 100 ('The best health you can imagine') where the patient reports his/her self-rated health. |
6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
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SANE
Periodo de tiempo: 6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
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The Single Assessment Numerical Evaluation (SANE) score is a single point, subjective estimate of a patient's condition. The patient is asked to rate their progress and current state on a scale of 0% - 100% of normal (e.g. How would you rate your shoulder today as a percentage of normal?) with 100% being considered normal. |
6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
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Patient Satisfaction
Periodo de tiempo: 6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
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Single-item satisfaction question - How satisfied are you with your shoulder replacement (so far)? 5 answer choices: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied |
6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
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Frequency and Incidence of Adverse Events (Safety)
Periodo de tiempo: 6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
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The frequency and incidence of adverse events, serious adverse events, adverse device effects, serious adverse device effects, and unanticipated serious adverse device effects as well as device deficiencies. |
6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
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Radiographic Performance [Radiolucency]
Periodo de tiempo: 6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
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X-rays will be evaluated for radiolucency lines to show the number of subjects with radiolucency. Radiolucency refers to structures that are less dense and permit the x-ray beam to pass through them. Radiolucent structures appear dark or black in the radiographic image. |
6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
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Radiographic Performance [Osteolysis]
Periodo de tiempo: 6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
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X-rays will be evaluated for osteolysis to show the number of subjects with osteolysis. Osteolysis is a progressive condition where bone tissue is destroyed. In this process, bones lose minerals (mostly calcium), softens, degenerates and become weaker. |
6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
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Radiographic Performance [Heterotopic Ossification]
Periodo de tiempo: 6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
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X-rays will be evaluated for heterotopic ossification to show the number of subjects with heterotopic ossification. Heterotopic ossification refers to the presence of bone in soft tissue where bone normally does not exist (extraskeletal bone). |
6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
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Radiographic Performance [Humeral Component Subsidence]
Periodo de tiempo: 6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
|
X-rays will be evaluated for humeral component subsidence to show the number of subjects with subsidence. Component Subsidence refers to the presence of the device component gradually sinking or caving into the bone structure. |
6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
|
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Radiographic Performance [Humeral Component Migration]
Periodo de tiempo: 6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
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X-rays will be evaluated for humeral component migration to show the number of subjects with migration. Component migration refers to the presence of the device component gradually moving anteriorly, posteriorly, superiorly, or inferiorly in relation to original placement. |
6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Jim Nevelos, Zimmer Biomet
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
- CMU2024-23E
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.
producto fabricado y exportado desde los EE. UU.
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