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Exactech Shoulder Post Market Clinical Follow-up Study

Sponsored by Exactech

About this study

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.

Where this study is enrolling (22)

  • South County Orthopedic Specialists

    Laguna Woods, California

    Call 949-586-3200

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  • Stanford Health Care

    Redwood City, California

    Call 650-723-5643

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  • Western Orthopaedics

    Denver, Colorado

    Call 303-321-1333

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  • Orthopaedic and Spine Center of the Rockies

    Fort Collins, Colorado

    Call 940-419-7050

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  • Mayo Clinic

    Jacksonville, Florida

    Call 904-953-2000

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Show all 22 locations

  • Florida Atlantis Orthopedics

    Palm Beach Gardens, Florida

    Call 561-627-8500

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  • Orthopaedic Medical Group of Tampa Bay

    Tampa, Florida

    Call 813-684-2663

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  • UF Health Orthopaedics and Sports Medicine Institute

    Gainesville, Florida

    Call 352-273-7001

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  • HSS Florida

    West Palm Beach, Florida

    Call 561-657-4610

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  • Orthopedic and Sports Medicine

    Augusta, Georgia

    Call 706-223-1493

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  • Barrington Orthpedic Specialists

    Schaumburg, Illinois

    Call (847) 285-4200

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  • OrthoIllinois

    Rockford, Illinois

    Call 815-398-9491

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  • Henry Ford Health

    Detroit, Michigan

    Call 800-436-7936

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  • Hospital for Joint Diseases - NYU Langone Health

    New York, New York

    Call 212-598-6000

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  • Lenox Health Greenwich Village

    New York, New York

    Call 646-665-6000

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  • Southeastern Sports Medicine and Orthopedics

    Asheville, North Carolina

    Call 828-274-4555

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  • Crystal Clinic Orthopaedic

    Akron, Ohio

    Call 330-668-4040

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  • Charleston Orthopaedic Associates

    Charleston, South Carolina

    Call 843-769-2000

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  • Steadman Hawkins Clinic of the Carolinas

    Greenville, South Carolina

    Call 864-454-7422

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  • Bone and Joint Institute of Tenessee

    Franklin, Tennessee

    Call 615-791-2630

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  • Atlantic Orthopaedics Specialists

    Virginia Beach, Virginia

    Call 757-321-3300

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  • Orthopaedic Associates of Wisconsin

    Pewaukee, Wisconsin

    Call 262-303-5055

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Who can participate

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)

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.