PMCF Study on the Safety, Performance and Clinical Benefits Data of the Anatomical Shoulder Bipolar System

Официальное название

Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Anatomical Shoulderᵀᴹ Bipolar System (Implants and Instrumentation) - A Retrospective and Prospective Consecutive Series Study

Обзор

The study is a monocentric, retrospective and prospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to collect long-term data confirming safety, performance and clinical benefits of the Anatomical Shoulder Bipolar System (Implants and Instrumentation) when used as a salvage solution in shoulder replacement. The primary objective is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified. The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcome measures (PROMs) as well as radiographic outcomes.

Подробное описание

The Anatomical Shoulder Bipolar System is intended for hemi shoulder replacement as a salvage solution in situations, where a Zimmer Anatomical Shoulder Inverse/Reverse prosthesis was originally planned, but it is intra-operatively found that the attachment of the Zimmer Anatomical Shoulder Inverse/Reverse glenoid fixation is not possible. The system is intended for long-term implantation into the human shoulder joint.

One site will be involved in this study. The aim is to include a maximum of 40 consecutive series cases who received the Anatomical Shoulder Bipolar starting from 2009 until 2020. All potential study subjects will be required to participate in the Informed Consent Process.

Baseline data from the preop, intraop and immediate post-op intervalls will be available in medical notes and collected retrospectively. During follow-up visits at 1, 2, 5, 7 and 10 years post-op (depending on patients' date of surgery), the patient will be asked to complete patient questionnaires. Moreover, a clinical assessment and a radiographic evaluation will be conducted. In addition, any complications and adverse events will also be collected during these follow-up visits.

Первичные конечные точки

• Incidence and frequency of revisions [Product safety based on implant survivorship] [Срок оценки: From operation to study completion, 1-10 years]

Вторичные конечные точки (4)

• Constant and Murley Score [Срок оценки: From post-operative to final follow-up visit, 1-10 years]
• Oxford Shoulder Score [Срок оценки: From post-operative to final follow-up visit, 1-10 years]
• EuroQol Five Dimensions Questionnaire [Срок оценки: From post-operative to final follow-up visit, 1-10 years]
• X-rays [Срок оценки: From post-operative to final follow-up visit, 1-10 years]

Критерии участия

Критерии включения

• The Anatomical Should Bipolar Adaptor is indicated for hemi shoulder replacement as a salvage solution in situations, where a Zimmer Anatomical Shoulder Inverse/Reverse prosthesis was originally planned, but it is intra-operatively found that the attachment of the Zimmer Anatomical Shoulder Inverse/Reverse glenoid fixation is not possible
• Patient should have received the Anatomical Shoulder Bipolar System
• Patient should have signed the Informed Consent Form
• Patient is 18-100 years of age, inclusive
• Patient is skeletally mature

Критерии исключения

• Patients who are not willing to return for study required follow-up visits and/or are not willing to comply with the follow-up schedule
• Patients who have any condition which would in the judgement of the Investigator place the patient at undue risk or interfere with the study. Any patient who is institutionalized, or is a known drug abuser, a known alcoholic or anyone who cannot understand what is required of them
• Patient is known to be pregnant or breastfeeding
• Musculoskeletal situation that enables the application of a regular hemi or total shoulder system
• Good quantity or quality of the glenoid bone, where the fixation of a Zimmer Anatomical Shoulder Inverse/Reverse glenoid fixation is possible
• Patient's physical conditions that would impair achieving adequate implant support, and/or prevent the use of an appropriately sized implant (e.g. due to insufficient quality or quantity of bone).
• Signs of infection
• Non-functional deltoid muscle
• Charcot's shoulder (neuroarthropathy)
• Presence of significant injury to the upper brachial plexus
• Any neuromuscular or vascular disease compromising the affected limb that would endanger the success of the intervention

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 1 центр

• Helios ENDO-Klinik — Hamburg

Идентификаторы

NCT: NCT05358574 · MDRG2017-89MS-130E

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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