Clinical trial NCT05603728: Exactech Shoulder Post Market Clinical Follow-up Study
Official title: An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Shoulder Arthroplasty Clinical and Radiographic Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteo Arthritis Shoulders
Osteonecrosis
Rotator Cuff Tears
Rotator Cuff Tear Arthropathy
Ankylosing Spondylitis
Post-traumatic Osteoarthritis
Rheumatoid Arthritis
Fracture
Infections
Lead sponsor: Exactech
Sponsor class: INDUSTRY
First posted: 2022-11-03
Enrollment: 20000
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who meet eligibility criteria - Patients who consent to participate to return for follow-up visits out to 10 years or longer

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Constant
timeFrame: Through study completion, an average of 1 per year
measure: ASES
timeFrame: Through study completion, an average of 1 per year
measure: Oxford Score (may be used as an optional form for surgeons in the United Kingdom)
timeFrame: Through study completion, an average of 1 per year
measure: TESS (may be used as specific forms related to the pre-operative condition/diagnosis)
timeFrame: Through study completion, an average of 1 per year
measure: MSTS (may be used as specific forms related to the pre-operative condition/diagnosis)
timeFrame: Through study completion, an average of 1 per year
Secondary outcomes:
Other outcomes:
Locations:
city: Laguna Woods
country: United States
facility: South County Orthopedic Specialists
state: California
city: Redwood City
country: United States
facility: Stanford Health Care
state: California
city: Stockton
country: United States
facility: Alpine Orthopaedic Medical Group
state: California
city: Denver
country: United States
facility: Western Orthopaedics
state: Colorado
city: Fort Collins
country: United States
facility: Orthopaedic and Spine Center of the Rockies
state: Colorado
city: Gainesville
country: United States
facility: UF Health Orthopaedics and Sports Medicine Institute
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Palm Beach Gardens
country: United States
facility: Palm Beach Orthopaedic Institute
state: Florida
city: Palm Beach Gardens
country: United States
facility: Florida Atlantis Orthopedics
state: Florida
city: Tampa
country: United States
facility: Orthopaedic Medical Group of Tampa Bay
state: Florida
city: Augusta
country: United States
facility: Orthopedic and Sports Medicine
state: Georgia
city: Rockford
country: United States
facility: OrthoIllinois
state: Illinois
city: Schaumburg
country: United States
facility: Barrington Orthpedic Specialists
state: Illinois
city: Detroit
country: United States
facility: Henry Ford Health
state: Michigan
city: New York
country: United States
facility: Hospital for Joint Diseases - NYU Langone Health
state: New York
city: New York
country: United States
facility: Lenox Health Greenwich Village
state: New York
city: Asheville
country: United States
facility: Southeastern Sports Medicine and Orthopedics
state: North Carolina
city: Durham
country: United States
facility: Duke Department of Orthopedic Surgery
state: North Carolina
city: Akron
country: United States
facility: Crystal Clinic Orthopaedic
state: Ohio
city: Charleston
country: United States
facility: Charleston Orthopaedic Associates
state: South Carolina
city: Greenville
country: United States
facility: Steadman Hawkins Clinic of the Carolinas
state: South Carolina
city: Franklin
country: United States
facility: Bone and Joint Institute of Tenessee
state: Tennessee
city: Virginia Beach
country: United States
facility: Atlantic Orthopaedics Specialists
state: Virginia
city: Pewaukee
country: United States
facility: Orthopaedic Associates of Wisconsin
state: Wisconsin
city: London
country: Canada
facility: St Joseph's Health Care
state: Ontario
city: Limoges
country: France
facility: Clinique Chenieux
city: Mérignac
country: France
facility: Centre de l'arthrose
city: Rennes
country: France
facility: Clinique Mutualiste La Sagesse
city: Catania
country: Italy
facility: Policlinico Morgagni
city: Eboli
country: Italy
facility: Campolongo Hospital
city: Reading
country: United Kingdom
facility: Circle Health Group
state: Berks
city: Yeovil
country: United Kingdom
facility: Yeovil District Hospital NHS Foundation Trust
state: Summerset
city: Bath
country: United Kingdom
facility: The Sulis Hospital Bath
city: Bedford
country: United Kingdom
facility: Bedford Hospital
city: Ipswich
country: United Kingdom
facility: Ipswich Hospital
city: Leicester
country: United Kingdom
facility: Leicester General Hospital
city: Manchester
country: United Kingdom
facility: University Hospital South Manchester
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospital
Study officials:
affiliation: UF Health Orthopaedics and Sports Medicine Institute
name: Jonathan Wright, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital for Joint Diseases - NYU Langone Health
name: Young Kwon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Charleston Orthopaedic Associates
name: Richard Friedman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Southeastern Orthopedics and Spine
name: Richard Jones, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Florida Atlantis Orthopaedics
name: Howard Routman, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Palm Beach Orthopaedic Institute
name: Ryan Simovitch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford Health Care
name: Geoffrey Abrams, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre de l'Arthrose
name: Pierre Henri Flurin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique Chenieux
name: Yann Marczuk, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Circle Health Group
name: Harry Brownlow, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yeovil District Hospital NHS Foundation
name: Oliver Donaldson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ipswich Hospital
name: Chris Roberts, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital South Manchester
name: Chris Peach, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Policlinico Morgagni
name: Angelo Di Giunta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Campolongo Hospital
name: Alfonso Romano, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Orthopaedic and Spine Center of the Rockies
name: Sean Grey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Altantic Orthopaedics Specialists
name: Chad Manke, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Orthopaedic Associates of Wisconsin
name: Rick Papandrea, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Sulis Hospital Bath
name: Andrew Chambler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Crystal Clinic Orthopaedic
name: Curt Noel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Orthopedic and Sports Medicine
name: Stephen Parada, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: South County Orthopedic Specialists
name: Ari Youderian, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bone and Joint Institute of Tennessee
name: Ian Byram, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique Mutualiste la Sagesse
name: Tewfik Benkalfate, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lenox Health Greenwich Village
name: Peter McCann, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Henry Ford Health
name: Stephanie Muh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Bradley Schoch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Steadman Hawkins Clinic of the Carolinas
name: Stephan Pill, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: OrthoIllinois
name: Scott Trenhaile, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Orthopaedic Medical Group of Tampa Bay
name: Bryan Butler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nottingham City Hospital
name: Ben Gooding, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Altantic Orthopaedics Specialist
name: Brad Carofino, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Western Orthopaedics
name: Ben Sears, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St Joseph's Health Care
name: Kenneth Faber, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alpine Orthopaedic Medical Group
name: Jaicharan Iyengar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke Department of Orthopedic Surgery
name: Oke Anakwenze, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Barrington Orthopedic
name: Thomas Obermeyer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Leicester General Hospital
name: Alison Armstrong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bedford Hospital
name: George Malal, MD
role: PRINCIPAL_INVESTIGATOR
References: