Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)

Exactech

Status: Terminated

Conditions: Oncology; Osteoarthritis Shoulder; Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT05615246

CR18-001

Details and patient eligibility

About

The objective of this study is to collect and evaluate long-term clinical outcomes data in order to better understand the safety and performance of the Equinoxe Humeral Reconstruction Prosthesis in shoulder arthroplasty over time. This study will follow subjects for a period of up to 10 years post-surgery.

Enrollment: 4 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient is indicated for shoulder arthroplasty (or has previously undergone shoulder arthroplasty)
• Patient is at least 21 years of age
• 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

Exclusion criteria

• Osteomyelitis of the proximal humerus or scapula; if a systemic infection or a secondary remote infection is suspected or confirmed, implentation should be delayed until infection is resolved
• Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis
• Neuromuscular disorders that do not allow control of the joint
• SIgnigicant 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 adversely affect the function or longevity of the implant
• Patient is pregnant
• Patient is a prisoner
• Patient has a physical or mental condition that would invalidate the results