INHANCE Stemless Reverse Shoulder IDE

Официальное название

Randomized, Prospective, Multi-Center Study of the INHANCE Stemless Total Reverse Shoulder System

Обзор

2:1 Randomized, Controlled, Multi-Center, Prospective, Pre-Market Study of the INHANCE Stemless Reverse Cementless Total Shoulder.

Подробное описание

There is one primary effectiveness endpoint and there are three primary safety endpoints:

1. Primary effectiveness endpoint - Adjusted Constant-Murley Change from Baseline (ACM CFB) at 2 years post-operative 2. Primary safety endpoint(s):

1. No revision, removal, reoperation, supplemental fixation, or other intervention for any system component 2. No humeral or glenoid radiolucent line \>2 mm is present in 50% or more zones at 2 years 3. No conclusive evidence of migration and tilt (\>5mm migration and \>10° tilt) of the humeral or glenoid component at 2 years

The study will be successful if the primary effectiveness endpoint non-inferiority analysis is successfully demonstrated, and no significant difference is seen on any of the 3 primary safety endpoints.

Вмешательства

• Устройство Reverse Total Shoulder
  Uncemented Reverse Total Shoulder

Первичные конечные точки

• Constant Murley Score (CMS) [Срок оценки: Pre-op, 2 years]
• Removal of any system component [Срок оценки: 2 year]
• Revision of any system component [Срок оценки: 2 year]
• Reoperation of any system component [Срок оценки: 2 year]
• Supplemental Fixation of any system component [Срок оценки: 2 year]
• Radiolucent Lines (Humeral & Glenoid) [Срок оценки: 2 year]
• Migration and Tilt (Humeral & Glenoid) [Срок оценки: 2 year]

Вторичные конечные точки (6)

• Constant Murley Score (CMS) [Срок оценки: Pre-op, 3-month, 6-month, 1 year, 2 year]
• EQ-5D-5L and EQ-VAS [Срок оценки: Pre-op, 3-month, 6-month, 1 year, 2 year]
• Simple Shoulder Test [Срок оценки: Pre-op, 3-month, 6-month, 1 year, 2 year]
• Single Assessment Numeric Evaluation (SANE) Score [Срок оценки: Pre-op, 3-month, 6-month, 1 year, 2 year]
• Survivorship [Срок оценки: 2 year]
• Complications [Срок оценки: 2 year]

Критерии участия

Критерии включения

• Individuals requiring reverse total shoulder replacement for a severely painful, disabling, arthritic joint (i.e. osteoarthritis, post-traumatic arthritis and rotator cuff arthropathy).
• Individuals who are anatomically and structurally suited to receive the implants and have a functional deltoid muscle.
• Individuals who are able to read and comprehend the informed patient consent document and are willing and able to provide informed patient consent for participation in the study and have authorized the transfer of their information to DePuy Synthes.
• Individuals who are willing and able to return for follow-up as specified by the study protocol.
• Individuals who are a minimum age of 22 years at the time of consent.
• Individuals who are willing and able to complete the Patient Reported Outcome Measure questionnaires (PROMs) as specified by the study protocol.

Критерии исключения

• BMI > 40 kg/m2
• Individuals have active, uncontrolled local infection or systemic infection.
• Patients who have not reached skeletal maturity, regardless of age.
• Either preoperatively or intraoperatively and per standard of care medical assessment, bone stock in the proximal humerus or glenoid fossa is determined to be inadequate for supporting the INHANCE humeral stemless components (NOTE: exclusion applies to both arms of the study, i.e., bone stock to be evaluated independent of randomized treatment assignment).
• Intraoperatively and per treating physician's assessment of bone quality, bone is determined to be too soft or porous to support the implant or that is too hard or brittle to allow for proper bone preparation and fixation, i.e. osteoporosis or sclerotic bone, or tumor(s) of the supporting bone structure, where there could be considerable migration of the prosthesis and/or a chance of fracture of the humerus or glenoid.
• Fractures of the proximal humerus that could compromise the fixation of the INHANCE reverse humeral stemless components.
• Patients who have undergone previous treatment on the study shoulder that may compromise fixation of the INHANCE reverse humeral stemless component.
• Revision of a failed hemi, total or reverse shoulder arthroplasty.
• Patient is receiving, or is scheduled to receive, treatment that the Investigator considers could affect bone quality, such as chemotherapy or high dose corticosteroids.
• Individuals who are bedridden per the Investigator's determination.
• Individuals that have participated in a clinical investigation with an investigational product (drug or device) in the last three months.
• Individuals currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
• Individuals, in the opinion of the Investigator, who are drug or alcohol abusers or have psychological disorders that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements.
• Patients with a known medical condition that the Investigator believes would impact the study outcomes (including, but not limited to osteomyelitis, Paget's disease, neuropathies such as Charcot's disease, metastatic or neoplastic disorders).
• Patient has a medical condition with less than 2 years life expectancy.
• Patients who are known to be pregnant or breastfeeding.
• Known polyethylene and/or metal sensitivity or allergy.
• Contralateral side has been enrolled in the study or has received a total shoulder operation within the last 6 months
• Otherwise determined by the investigator to be medically unsuitable for participation in this study
• Patient is a member of a vulnerable population (i.e., incarcerated individuals - those incarcerated for at least one month and considered to be an inmate)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 19 центров

• Hoag Orthopedic Institute — Irvine
• Cedars Sinai Medical Center — Los Angeles
• Orthopedic Center of Palm Beach County — Atlantis
• Hospital for Special Surgery — West Palm Beach
• Boston Bone & Joint Institute BBJI Formerly BSSC — Waltham
• Trinity Health Grand Rapids — Grand Rapids
• Missouri Orthopaedic Institute (MOI) — Columbia
• OrthoCarolina Research Institute Charlotte — Charlotte
• … и ещё 11 центров

Идентификаторы

NCT: NCT06323980 · DSM202108 · DSM202108

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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