MDR - Comprehensive Reverse/Versa Dial Ti Glenosphere

Официальное название

Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Comprehensive Versa-Dial Reverse Titanium (Ti) Glenosphere in Primary, Fracture and Revision Total Shoulder Arthroplasty

Обзор

The objective of this retrospective/prospective consecutives series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Versa-Dial Reverse Ti Glenosphere when used for primary total shoulder arthroplasty (implants and instrumentation) at a 1,2,3,5,7, and 10- year follow-up\* to meet EU Medical Device and other Regulatory Requirements for Post-Market Surveillance. Because Comprehensive Versa-Dial Reverse Ti Glenospheres have only been on the market since 2009, a prospective aspect to the study will be utilized as well to collect long-term data. \*The most recent available data will be used. If any of the listed time points are not available, data will be used from last available time point and follow-up will move forward at the closest available time point.

Подробное описание

The objective of this retrospective/prospective consecutives series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Versa-Dial Reverse Ti Glenosphere when used for primary total shoulder arthroplasty (implants and instrumentation) at a 1,2,3,5,7, and 10- year follow-up\* to meet EU Medical Device and other Regulatory Requirements for Post-Market Surveillance. Because Comprehensive Versa-Dial Reverse Ti Glenospheres have only been on the market since 2009, a prospective aspect to the study will be utilized as well to collect long-term data.

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 either implant or instrumentation should be specified.

The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs).

\*The most recent available data will be used. If any of the listed time points are not available, data will be used from last available time point and follow-up will move forward at the closest available time point.

Вмешательства

• Устройство Comprehensive Reverse Versa-Dial Titanium Glenosphere
  Implant used for patients with allergy to typical device material metals to repair shoulder malfunction/disease.

Первичные конечные точки

• Product Safety assessed through the incidence and frequency of revisions, complications and adverse events [Срок оценки: Out to 10 years]

Вторичные конечные точки (2)

• Product Clinical Benefits and Performance evaluated through the Oxford Shoulder Scale OSS or Oxford Shoulder Questionnaire. [Срок оценки: Out to10 years]
• Product Clinical Benefits and Performance evaluated through the Patient Assessment Questionnaire [Срок оценки: Out to 10 years]

Критерии участия

Критерии включения

• Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.

Interlok™ finish humeral stems are intended for cemented use and the MacroBond™ coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

\*\*\* For the specific components, Titanium (Ti) Glenospheres are intended for patients with Cobalt Alloy material sensitivity.

Критерии исключения

• Absolute contraindications include infection, sepsis, and osteomyelitis.

Relative contraindications include:

• Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.
• Osteoporosis.
• Metabolic disorders which may impair bone formation.
• Osteomalacia.
• Distant foci of infections which may spread to the implant site.
• Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.
• Patient is a prisoner.
• Current alcohol or drug abuser.
• If female, patient is known to be pregnant or breastfeeding.
• Patient has a psychiatric illness or cognitive deficit that will not allow from proper informed consent.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 2 центра

• Norton Orthopaedic and Sports Medicine — Louisville
• University of Buffalo — Buffalo

Идентификаторы

NCT: NCT04003272 · MDRG2017-89MS-40E

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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