RECRUITING

Exactech Shoulder Post Market Clinical Follow-up Study

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

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2010-01

Study Completion:2031-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05603728

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.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)

Inclusion Criteria

Exclusion 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)

Contacts and Locations

Study Contact

Rachael Craig

CONTACT

352-377-1140

rachael.craig@exac.com

Sandrine Angibaud

CONTACT

352-377-1140

sandrine.angibaud@exac.com

Principal Investigator

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 Locations (Sites)

South County Orthopedic Specialists

Laguna Woods, California, 92637

United States

Stanford Health Care

Redwood City, California, 94063

United States

Western Orthopaedics

Denver, Colorado, 80218

United States

Orthopaedic and Spine Center of the Rockies

Fort Collins, Colorado, 80525

United States

UF Health Orthopaedics and Sports Medicine Institute

Gainesville, Florida, 32607

United States

Mayo Clinic

Jacksonville, Florida, 32224

United States

Palm Beach Orthopaedic Institute

Palm Beach Gardens, Florida, 33401

United States

Florida Atlantis Orthopedics

Palm Beach Gardens, Florida, 33410

United States

Orthopaedic Medical Group of Tampa Bay

Tampa, Florida, 33619

United States

Orthopedic and Sports Medicine

Augusta, Georgia, 30909

United States

OrthoIllinois

Rockford, Illinois, 61107

United States

Henry Ford Health

Detroit, Michigan, 48067

United States

Hospital for Joint Diseases - NYU Langone Health

New York, New York, 10003

United States

Lenox Health Greenwich Village

New York, New York, 10011

United States

Southeastern Sports Medicine and Orthopedics

Asheville, North Carolina, 28803

United States

Crystal Clinic Orthopaedic

Akron, Ohio, 44333

United States

Charleston Orthopaedic Associates

Charleston, South Carolina, 29414

United States

Steadman Hawkins Clinic of the Carolinas

Greenville, South Carolina, 29615

United States

Bone and Joint Institute of Tenessee

Franklin, Tennessee, 37067

United States

Atlantic Orthopaedics Specialists

Virginia Beach, Virginia, 23320

United States

Orthopaedic Associates of Wisconsin

Pewaukee, Wisconsin, 53072

United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2010-01

Study Completion Date2031-09-30

Study Record Updates

Study Start Date2010-01

Study Completion Date2031-09-30

Terms related to this study

Additional Relevant MeSH Terms

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