Recruiting

Observational StudyExactech Shoulder Post Market Clinical Follow-up Study

Sponsor:

Exactech

Code:

NCT05603728

Conditions

Osteo Arthritis Shoulders

Osteonecrosis

Rotator Cuff Tears

Rotator Cuff Tear Arthropathy

Ankylosing Spondylitis

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Osteo Arthritis Shoulders

Osteonecrosis

Rotator Cuff Tears

Rotator Cuff Tear Arthropathy

Ankylosing Spondylitis

Study ID

NCT05603728

Start date

Jul 19, 2007

Status verified date

Sep, 2026

Completion date

Dec 31, 2031

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

20000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

Constant [ Time Frame: Through study completion, an average of 1 per year ]
ASES [ Time Frame: Through study completion, an average of 1 per year ]
Oxford Score (may be used as an optional form for surgeons in the United Kingdom) [ Time Frame: Through study completion, an average of 1 per year ]
TESS (may be used as specific forms related to the pre-operative condition/diagnosis) [ Time Frame: Through study completion, an average of 1 per year ]
MSTS (may be used as specific forms related to the pre-operative condition/diagnosis) [ Time Frame: Through study completion, an average of 1 per year ]

Central Contacts and Locations

Central contacts

Rachael Craig

1-833-423-8482 rachael.craig@advita.com

Sandrine Angibaud

1-833-423-8482 sandrine.angibaud@advita.com

Locations

South County Orthopedic Specialists

Recruiting

Laguna Woods, California, United States, 92637

Contacts

949-586-3200

Stanford Health Care

Recruiting

Redwood City, California, United States, 94063

Contacts

Anna Ramakrishnan

650-723-5643

Alpine Orthopaedic Medical Group

Recruiting

Stockton, California, United States, 95204-5508

Western Orthopaedics

Recruiting

Denver, Colorado, United States, 80218

Contacts

Libby Mauter

303-321-1333

Orthopaedic and Spine Center of the Rockies

Recruiting

Fort Collins, Colorado, United States, 80525

Contacts

Josh Orr

940-419-7050

UF Health Orthopaedics and Sports Medicine Institute

Recruiting

Gainesville, Florida, United States, 32607

Contacts

Aimee Struk

352-273-7001

Mayo Clinic

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Jennnifer Wirtz

904-953-2000

Florida Atlantis Orthopedics

Recruiting

Palm Beach Gardens, Florida, United States, 33410

Contacts

Rachel Routman

561-627-8500

Orthopaedic Medical Group of Tampa Bay

Recruiting

Tampa, Florida, United States, 33619

Contacts

Kendra Richerdson

813-684-2663

HSS Florida

Recruiting

West Palm Beach, Florida, United States, 33401

Contacts

Meg Ryan

561-657-4610

Orthopedic and Sports Medicine

Recruiting

Augusta, Georgia, United States, 30909

Contacts

Elizabeth Barker

706-223-1493

OrthoIllinois

Recruiting

Rockford, Illinois, United States, 61107

Contacts

Timothy Nelligan

815-398-9491

Barrington Orthpedic Specialists

Recruiting

Schaumburg, Illinois, United States, 60195

Henry Ford Health

Recruiting

Detroit, Michigan, United States, 48067

Contacts

Johnny Kasto

800-436-7936

Hospital for Joint Diseases - NYU Langone Health

Recruiting

New York, New York, United States, 10003

Contacts

212-598-6000

Lenox Health Greenwich Village

Recruiting

New York, New York, United States, 10011

Contacts

Johnathan Joseph

646-665-6000

Southeastern Sports Medicine and Orthopedics

Recruiting

Asheville, North Carolina, United States, 28803

Contacts

Rebecca Rathbone

828-274-4555

Duke Department of Orthopedic Surgery

Recruiting

Durham, North Carolina, United States, 27705

Crystal Clinic Orthopaedic

Recruiting

Akron, Ohio, United States, 44333

Contacts

Ginny Texter

330-668-4040

Charleston Orthopaedic Associates

Recruiting

Charleston, South Carolina, United States, 29414

Contacts

Lisa Mock

843-769-2000

Steadman Hawkins Clinic of the Carolinas

Recruiting

Greenville, South Carolina, United States, 29615

Contacts

Kyle Adams

864-454-7422

Bone and Joint Institute of Tenessee

Recruiting

Franklin, Tennessee, United States, 37067

Contacts

Kristin Freeman

615-791-2630

Atlantic Orthopaedics Specialists

Recruiting

Virginia Beach, Virginia, United States, 23320

Contacts

Brice Snyder

757-321-3300

Orthopaedic Associates of Wisconsin

Recruiting

Pewaukee, Wisconsin, United States, 53072

Contacts

Ryann Hamm

262-303-5055

St Joseph's Health Care

Recruiting

London, Ontario, Canada, N6A 4V2

More Information

Sponsor

Exactech

Last update posted

Sep 17, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-11. This information was provided to ClinicalTrials.gov by Exactech on 2026-09-17. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.