Exactech Shoulder Post Market Clinical Follow-up Study

Description

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.

Conditions

Osteo Arthritis Shoulders, Osteonecrosis, Rotator Cuff Tears, Rotator Cuff Tear Arthropathy, Ankylosing Spondylitis, Post-traumatic Osteoarthritis, Rheumatoid Arthritis, Fracture, Infections

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Study Overview

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Study Details

Study overview

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.

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

Exactech Shoulder Post Market Clinical Follow-up Study

Condition
Osteo Arthritis Shoulders
Intervention / Treatment

-

Contacts and Locations

Laguna Woods

South County Orthopedic Specialists, Laguna Woods, California, United States, 92637

Redwood City

Stanford Health Care, Redwood City, California, United States, 94063

Denver

Western Orthopaedics, Denver, Colorado, United States, 80218

Fort Collins

Orthopaedic and Spine Center of the Rockies, Fort Collins, Colorado, United States, 80525

Gainesville

UF Health Orthopaedics and Sports Medicine Institute, Gainesville, Florida, United States, 32607

Jacksonville

Mayo Clinic, Jacksonville, Florida, United States, 32224

Palm Beach Gardens

Palm Beach Orthopaedic Institute, Palm Beach Gardens, Florida, United States, 33401

Palm Beach Gardens

Florida Atlantis Orthopedics, Palm Beach Gardens, Florida, United States, 33410

Tampa

Orthopaedic Medical Group of Tampa Bay, Tampa, Florida, United States, 33619

Augusta

Orthopedic and Sports Medicine, Augusta, Georgia, United States, 30909

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Exactech,

Jonathan Wright, MD, PRINCIPAL_INVESTIGATOR, UF Health Orthopaedics and Sports Medicine Institute

Young Kwon, MD, PRINCIPAL_INVESTIGATOR, Hospital for Joint Diseases - NYU Langone Health

Richard Friedman, MD, PRINCIPAL_INVESTIGATOR, Charleston Orthopaedic Associates

Richard Jones, MD, PRINCIPAL_INVESTIGATOR, Southeastern Sports Medicine and Orthopedics

Howard Routman, DO, PRINCIPAL_INVESTIGATOR, Florida Atlantis Orthopaedics

Ryan Simovitch, MD, PRINCIPAL_INVESTIGATOR, Palm Beach Orthopaedic Institute

Geoffrey Abrams, MD, PRINCIPAL_INVESTIGATOR, Stanford Health Care

Pierre Henri Flurin, MD, PRINCIPAL_INVESTIGATOR, Centre de l'Arthrose

Yann Marczuk, MD, PRINCIPAL_INVESTIGATOR, Clinique Chenieux

Stephane Menager, MD, PRINCIPAL_INVESTIGATOR, Cite Sante

Ahmed Juanroyee, MD, PRINCIPAL_INVESTIGATOR, Gloucester Royal Hospital Foundation Trust

Harry Brownlow, MD, PRINCIPAL_INVESTIGATOR, Circle Health Group

Oliver Donaldson, MD, PRINCIPAL_INVESTIGATOR, Yeovil District Hospital NHS Foundation

Chris Roberts, MD, PRINCIPAL_INVESTIGATOR, Ipswitch Hospital

Chris Peach, MD, PRINCIPAL_INVESTIGATOR, University Hospital South Manchester

Angelo Di Giunta, MD, PRINCIPAL_INVESTIGATOR, Policlinico Morgagni

Alfonso Romano, MD, PRINCIPAL_INVESTIGATOR, Campolongo Hospital

Sean Grey, MD, PRINCIPAL_INVESTIGATOR, Orthopaedic and Spine Center of the Rockies

Chad Manke, MD, PRINCIPAL_INVESTIGATOR, Altantic Orthopaedics Specialists

Rick Papandrea, MD, PRINCIPAL_INVESTIGATOR, Orthopaedic Associates of Wisconsin

Andrew Chambler, MD, PRINCIPAL_INVESTIGATOR, The Sulis Hospital Bath

Curt Noel, MD, PRINCIPAL_INVESTIGATOR, Crystal Clinic Orthopaedic

Stephen Parada, MD, PRINCIPAL_INVESTIGATOR, Orthopedic and Sports Medicine

Ari Youderian, MD, PRINCIPAL_INVESTIGATOR, South County Orthopedic Specialists

Ian Byram, MD, PRINCIPAL_INVESTIGATOR, Bone and Joint Institute of Tennessee

Tewfik Benkalfate, MD, PRINCIPAL_INVESTIGATOR, Clinique Mutualiste la Sagesse

Peter McCann, MD, PRINCIPAL_INVESTIGATOR, Lenox Health Greenwich Village

Stephanie Muh, MD, PRINCIPAL_INVESTIGATOR, Henry Ford Health

Bradley Schoch, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Stephan Pill, MD, PRINCIPAL_INVESTIGATOR, Steadman Hawkins Clinic of the Carolinas

Scott Trenhaile, MD, PRINCIPAL_INVESTIGATOR, OrthoIllinois

Bryan Butler, MD, PRINCIPAL_INVESTIGATOR, Orthopaedic Medical Group of Tampa Bay

Ben Gooding, MD, PRINCIPAL_INVESTIGATOR, Circle Nottingham Limited

Brad Carofino, MD, PRINCIPAL_INVESTIGATOR, Altantic Orthopaedics Specialist

Ben Sears, MD, PRINCIPAL_INVESTIGATOR, Western Orthopaedics

Study Record Dates

2031-09-30