Exactech Shoulder Post Market Clinical Follow-up Study

Last updated: February 26, 2025
Sponsor: Exactech
Overall Status: Active - Recruiting

Phase

N/A

Condition

Rheumatoid Arthritis

Osteomyelitis

Arthritis And Arthritic Pain

Treatment

N/A

Clinical Study ID

NCT05603728
CR09-005
  • Ages > 21
  • All Genders

Study 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

Inclusion Criteria:

  • Patient is indicated for shoulder arthroplasty (or has previously undergone shoulderarthroplasty)

  • 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 visitrequirements

  • Patient is willing and able to read and sign a study informed consent form

Exclusion

Exclusion Criteria:

  • Osteomyelitis of the proximal humerus or scapula; if a systemic infection or asecondary remote infection is suspected or confirmed, implantation should be delayeduntil infection is resolved

  • Inadequate or malformed bone that precludes adequate support or fixation of theprosthesis

  • Medial humeral bone loss resulting in compromised humeral stem fixation

  • Proximal humeral bone loss extending distal to the surgical neck where there iscompromised 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 earlyfailure of the system

  • The patient is unwilling or unable to comply with the post-operative careinstructions

  • Alcohol, drug, or other subtance abuse

  • Any disease state that could adversaly affect the function or longevity of theimplant

  • Patient is pregnant

  • Patient is a prisoner

  • Patient is contraindicated for the surgery

  • Revision cases in which a stemmed humeral component was used (Stemless ShoulderSystem)

  • 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 ofthe glenohumeral joint and a grossly deficient, irreparable rotator cuff resultingin superior migration of the humeral head (reverse total shoulder arthroplasty) (Stemless Shoulder System)

Study Design

Total Participants: 20000
Study Start date:
January 01, 2010
Estimated Completion Date:
December 31, 2031

Connect with a study center

  • St Joseph's Health Care

    London, Ontario N6A 4V2
    Canada

    Active - Recruiting

  • Cite Sante

    Cavaillon, 84300
    France

    Site Not Available

  • Clinique Chenieux

    Limoges, 87039
    France

    Active - Recruiting

  • Centre de l'arthrose

    Mérignac, 33700
    France

    Active - Recruiting

  • Clinique Mutualiste La Sagesse

    Rennes, 35043
    France

    Active - Recruiting

  • Policlinico Morgagni

    Catania, 95125
    Italy

    Active - Recruiting

  • Campolongo Hospital

    Eboli, 84025
    Italy

    Active - Recruiting

  • Circle Health Group

    Reading, Berks RG2 7AU
    United Kingdom

    Active - Recruiting

  • Yeovil District Hospital NHS Foundation Trust

    Yeovil, Summerset BA21 4AT
    United Kingdom

    Active - Recruiting

  • The Sulis Hospital Bath

    Bath, BA2 8SQ
    United Kingdom

    Active - Recruiting

  • Bedford Hospital

    Bedford, MK42 9DJ
    United Kingdom

    Active - Recruiting

  • Gloucester Royal Hospital Foundation Trust

    Gloucester, GL1 3NN
    United Kingdom

    Site Not Available

  • Ipswich Hospital

    Ipswich, IP4 5PD
    United Kingdom

    Active - Recruiting

  • Leicester General Hospital

    Leicester, LE5 4PW
    United Kingdom

    Active - Recruiting

  • University Hospital South Manchester

    Manchester, M23 9LT
    United Kingdom

    Active - Recruiting

  • Nottingham University Hospital

    Nottingham,
    United Kingdom

    Active - Recruiting

  • South County Orthopedic Specialists

    Laguna Woods, California 92637
    United States

    Active - Recruiting

  • Stanford Health Care

    Redwood City, California 94063
    United States

    Active - Recruiting

  • Alpine Orthopaedic Medical Group

    Stockton, California 95204-5508
    United States

    Active - Recruiting

  • Western Orthopaedics

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Orthopaedic and Spine Center of the Rockies

    Fort Collins, Colorado 80525
    United States

    Active - Recruiting

  • UF Health Orthopaedics and Sports Medicine Institute

    Gainesville, Florida 32607
    United States

    Active - Recruiting

  • Mayo Clinic

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • Florida Atlantis Orthopedics

    Palm Beach Gardens, Florida 33410
    United States

    Active - Recruiting

  • Palm Beach Orthopaedic Institute

    Palm Beach Gardens, Florida 33401
    United States

    Active - Recruiting

  • Orthopaedic Medical Group of Tampa Bay

    Tampa, Florida 33619
    United States

    Active - Recruiting

  • Orthopedic and Sports Medicine

    Augusta, Georgia 30909
    United States

    Active - Recruiting

  • OrthoIllinois

    Rockford, Illinois 61107
    United States

    Active - Recruiting

  • Barrington Orthpedic Specialists

    Schaumburg, Illinois 60195
    United States

    Active - Recruiting

  • Henry Ford Health

    Detroit, Michigan 48067
    United States

    Active - Recruiting

  • Hospital for Joint Diseases - NYU Langone Health

    New York, New York 10003
    United States

    Active - Recruiting

  • Lenox Health Greenwich Village

    New York, New York 10011
    United States

    Active - Recruiting

  • Southeastern Sports Medicine and Orthopedics

    Asheville, North Carolina 28803
    United States

    Active - Recruiting

  • Duke Department of Orthopedic Surgery

    Durham, North Carolina 27705
    United States

    Active - Recruiting

  • Crystal Clinic Orthopaedic

    Akron, Ohio 44333
    United States

    Active - Recruiting

  • Charleston Orthopaedic Associates

    Charleston, South Carolina 29414
    United States

    Active - Recruiting

  • Steadman Hawkins Clinic of the Carolinas

    Greenville, South Carolina 29615
    United States

    Active - Recruiting

  • Bone and Joint Institute of Tenessee

    Franklin, Tennessee 37067
    United States

    Active - Recruiting

  • Atlantic Orthopaedics Specialists

    Virginia Beach, Virginia 23320
    United States

    Active - Recruiting

  • Orthopaedic Associates of Wisconsin

    Pewaukee, Wisconsin 53072
    United States

    Active - Recruiting

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