MDR - Comprehensive Primary/Micro Stem & Versa-Dial Ti Humeral Head

Официальное название

Comprehensive® Primary Micro Stem and Comprehensive® Anatomic Versa-Dial Titanium Humeral Heads in Primary and Revision Total Shoulder Arthroplasty

Обзор

The objective of this retrospective/prospective enrollment and prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Primary Micro Stem and Comprehensive Anatomic Versa-Dial Titanium Humeral Heads when used for primary and revision total shoulder arthroplasty (implants and instrumentation) at 1,3,5,7 and 10 years\*. Comprehensive Primary Micro Stem and Comprehensive Anatomic Versa-Dial Titanium Humeral Heads have been on the market since 2007, but have insufficient data to support 10 years of clinical history. Therefore, a prospective aspect to the study will be utilized in order to collect long-term data.

Подробное описание

The objective of this retrospective/prospective enrollment and prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Primary Micro Stem and Comprehensive Anatomic Versa-Dial Titanium Humeral Heads when used for primary and revision total shoulder arthroplasty (implants and instrumentation) at 1,2,3,5,7 and 10 years\*. Comprehensive Primary Micro Stem and Comprehensive Anatomic Versa-Dial Titanium Humeral Heads have been on the market since 2007, but have insufficient data to support 10 years of clinical history. Therefore, a prospective aspect to the study will be utilized in order to collect long-term data.

The primary objective of this study 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 Primary Micro Stem
  Patients that have been implanted with the Comprehensive Primary Micro Stem to repair shoulder malfunction/disease.
• Устройство Comprehensive Anatomic Versa-Dial Titanium Humeral Head
  Patients that have been implanted with the Comprehensive Anatomic Versa-Dial Titanium Humeral head to repair shoulder malfunction/disease.

Первичные конечные точки

• Device Safety assessed through the frequency and incidence of revisions, complications and Adverse Events [Срок оценки: Out to 10 years]

Вторичные конечные точки (2)

• Device Performance and Benefits evaluated through the Oxford Shoulder Score outcome measure. [Срок оценки: Out to 10 years]
• Device Performance and Benefits evaluated through the Patient Assessment Questionnaire. [Срок оценки: Out to 10 years]

Критерии участия

Критерии включения

• Study devices must have been implanted following the surgical technique and IFU for the Comprehensive Micro Stem and/or the Comprehensive Anatomic Versa-Dial Humeral Heads
• Patient must be 18 years of age or older.
• Patient must have undergone a primary or revision shoulder arthroplasty with the Comprehensive Micro Stem and/or the Comprehensive Anatomic Versa-Dial Humeral Heads for a cleared indication. Cleared indications include the following:

• non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
• rheumatoid arthritis,
• revision where other devices or treatments have failed,
• correction of functional deformity,
• fractures of the proximal humerus where other methods of treatment are deemed inadequate,
• difficult clinical management problems including cuff arthroplasty where other treatment methods may not be suitable or may be inadequate.

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.
• Patient is a current alcohol or drug abuser.
• Patient is known to be pregnant or breastfeeding.
• Patient has a psychiatric illness or cognitive deficit that will not allow for 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 · 4 центра

• Shoulder Clinic of Idaho — Boise
• Beaumont Health — Royal Oak
• University of Rochester — Rochester
• Department of Orthopaedics & Rehabilitation The Larner College of Medicine at The Universi — Burlington

Идентификаторы

NCT: NCT04003311 · MDRG2017-89MS-46E

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗