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NCT05615246 | RECRUITING | Osteoarthritis Shoulder

Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
Sponsor:

Exactech

Brief Summary:

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.

Condition or disease

Osteoarthritis Shoulder

Rheumatoid Arthritis

Oncology

Study Type : OBSERVATIONAL
Estimated Enrollment : 100 participants
Official Title : An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty
Actual Study Start Date : 2018-09-05
Estimated Primary Completion Date : 2030-12-31
Estimated Study Completion Date : 2031-09-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 21 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)

Location Details

NCT05615246

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How to Participate

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Locations

RECRUITING

United States, Colorado

Western Orthopaedics Research and Education Foundation

Denver, Colorado, United States, 80218