Exactech Shoulder Post Market Clinical Follow-up Study

Официальное название

An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Shoulder Arthroplasty Clinical and Radiographic Outcomes

Обзор

The objective of this study is to collect and evaluate long-term clinical and radiographic outcomes data in order to better understand the safety and performance of the shoulder arthroplasty over time. This study will follow subjects long-term for a minimum of 10-years, without an early-term restriction on the amount of time they will be followed.

Первичные конечные точки

• Constant [Срок оценки: Through study completion, an average of 1 per year]
• ASES [Срок оценки: Through study completion, an average of 1 per year]
• Oxford Score (may be used as an optional form for surgeons in the United Kingdom) [Срок оценки: Through study completion, an average of 1 per year]
• TESS (may be used as specific forms related to the pre-operative condition/diagnosis) [Срок оценки: Through study completion, an average of 1 per year]
• MSTS (may be used as specific forms related to the pre-operative condition/diagnosis) [Срок оценки: Through study completion, an average of 1 per year]

Критерии участия

Критерии включения

• Patient is indicated for shoulder arthroplasty (or has previously undergone shoulder arthroplasty)
• Patient is skeletelly mature
• Patient is expected to survive at least 2 years beyond surgery
• Patient is willing to participate by complying with pre- and postoperative visit requirements
• Patient is willing and able to read and sign a study informed consent form

Критерии исключения

• Osteomyelitis of the proximal humerus or scapula; if a systemic infection or a secondary remote infection is suspected or confirmed, implantation should be delayed until infection is resolved
• Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis
• Medial humeral bone loss resulting in compromised humeral stem fixation
• Proximal humeral bone loss extending distal to the surgical neck where there is compromised humeral stem fixation
• Neuromuscular disorders that do not allow control of the joint
• Significant injury to the brachial plexus
• Non-functional deltoid muscles
• Patient's age, weight, or activity level would cause the surgeon to expect early failure of the system
• The patient is unwilling or unable to comply with the post-operative care instructions
• Alcohol, drug, or other subtance abuse
• Any disease state that could adversaly affect the function or longevity of the implant
• Patient is pregnant
• Patient is a prisoner
• Patient is contraindicated for the surgery
• Revision cases in which a stemmed humeral component was used (Stemless Shoulder System)
• Metal allergy or sensitivity to the implants materials (Stemless Shoulder System)
• Acute fracture of the proximal humerus and displacement of the tuberosities, displaced three or four part fractures of the proximal humerus (hemi-arthroplasty), or acture fracture of the proximal humerus with failure of the glenohumeral joint (total anatomic shoulder arthroplasty) (Stemless Shoulder System)
• Acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty) (Stemless Shoulder System)

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 · 24 центра

• South County Orthopedic Specialists — Laguna Woods
• Stanford Health Care — Redwood City
• Alpine Orthopaedic Medical Group — Stockton
• Western Orthopaedics — Denver
• Orthopaedic and Spine Center of the Rockies — Fort Collins
• UF Health Orthopaedics and Sports Medicine Institute — Gainesville
• Mayo Clinic — Jacksonville
• Palm Beach Orthopaedic Institute — Palm Beach Gardens
• … и ещё 16 центров

Великобритания · 8 центров

• Circle Health Group — Reading
• Yeovil District Hospital NHS Foundation Trust — Yeovil
• The Sulis Hospital Bath — Bath
• Bedford Hospital — Bedford
• Ipswich Hospital — Ipswich
• Leicester General Hospital — Leicester
• University Hospital South Manchester — Manchester
• Nottingham University Hospital — Nottingham

Франция · 3 центра

• Clinique Chenieux — Limoges
• Centre de l'arthrose — Mérignac
• Clinique Mutualiste La Sagesse — Rennes

Италия · 2 центра

• Policlinico Morgagni — Catania
• Campolongo Hospital — Eboli

Канада · 1 центр

• St Joseph's Health Care — London

Идентификаторы

NCT: NCT05603728 · CR09-005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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