Exactech Shoulder Post Market Clinical Follow-up Study

NCT05603728 | Recruiting

• 1 other identifier: CR09-005
• Study Type: observational
• Target: 20,000
• Locations: 5 countries
• Sites: 38

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

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

Outcome Measures

Primary Outcomes (5)

• Constant

  Constant Shoulder Score - 100 points scale about pain, Activities of daily living, Strength test, and Range of Motions questions about shoulder where 100 % corresponds to the highest pain

  Through study completion, an average of 1 per year

• ASES

  American Shoulder and Elbow Surgeons Score (ASES) - 100 points scale about shoulder pain and performance evaluation in activities of daily living where 100 indicates the best shoulder condition

  Through study completion, an average of 1 per year

• Oxford Score (may be used as an optional form for surgeons in the United Kingdom)

  Oxford Shoulder Score (OSS) - 12 questions assessing outcomes of shoulder surgery and its impact on patients' quality of life of degenerative conditions such as arthritis and rotator cuff problems - Maximum score is 60 and indicates greater degree of disability

  Through study completion, an average of 1 per year

• TESS (may be used as specific forms related to the pre-operative condition/diagnosis)

  Toronto Extremity Salvage Score (TESS) - Patient functional assessment following for surgery for musculoskeletal tumors (Humeral Reconstruction Stem only) - 100-point score where higher score indicates a better outcome

  Through study completion, an average of 1 per year

• MSTS (may be used as specific forms related to the pre-operative condition/diagnosis)

  Musculoskeletal Tumor Society (MSTS) - 30 points \[6 times (range 0-5)\], simple measure of the upper extremity function (Humeral Reconstruction Stem only) - The maximum corresponds to the best score

  Through study completion, an average of 1 per year

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Exactech: lead

Study Sites (38)

South County Orthopedic Specialists

Laguna Woods, California, 92637, United States

RECRUITING

Stanford Health Care

Redwood City, California, 94063, United States

RECRUITING

Alpine Orthopaedic Medical Group

Stockton, California, 95204-5508, United States

RECRUITING

Western Orthopaedics

Denver, Colorado, 80218, United States

RECRUITING

Orthopaedic and Spine Center of the Rockies

Fort Collins, Colorado, 80525, United States

RECRUITING

UF Health Orthopaedics and Sports Medicine Institute

Gainesville, Florida, 32607, United States

RECRUITING

Mayo Clinic

Jacksonville, Florida, 32224, United States

RECRUITING

Palm Beach Orthopaedic Institute

Palm Beach Gardens, Florida, 33401, United States

RECRUITING

Florida Atlantis Orthopedics

Palm Beach Gardens, Florida, 33410, United States

RECRUITING

Orthopaedic Medical Group of Tampa Bay

Tampa, Florida, 33619, United States

RECRUITING

Orthopedic and Sports Medicine

Augusta, Georgia, 30909, United States

RECRUITING

OrthoIllinois

Rockford, Illinois, 61107, United States

RECRUITING

Barrington Orthpedic Specialists

Schaumburg, Illinois, 60195, United States

RECRUITING

Henry Ford Health

Detroit, Michigan, 48067, United States

RECRUITING

Hospital for Joint Diseases - NYU Langone Health

New York, New York, 10003, United States

RECRUITING

Lenox Health Greenwich Village

New York, New York, 10011, United States

RECRUITING

Southeastern Sports Medicine and Orthopedics

Asheville, North Carolina, 28803, United States

RECRUITING

Duke Department of Orthopedic Surgery

Durham, North Carolina, 27705, United States

RECRUITING

Crystal Clinic Orthopaedic

Akron, Ohio, 44333, United States

RECRUITING

Charleston Orthopaedic Associates

Charleston, South Carolina, 29414, United States

RECRUITING

Steadman Hawkins Clinic of the Carolinas

Greenville, South Carolina, 29615, United States

RECRUITING

Bone and Joint Institute of Tenessee

Franklin, Tennessee, 37067, United States

RECRUITING

Atlantic Orthopaedics Specialists

Virginia Beach, Virginia, 23320, United States

RECRUITING

Orthopaedic Associates of Wisconsin

Pewaukee, Wisconsin, 53072, United States

RECRUITING

St Joseph's Health Care

London, Ontario, N6A 4V2, Canada

RECRUITING

Clinique Chenieux

Limoges, 87039, France

RECRUITING

Centre de l'arthrose

Mérignac, 33700, France

RECRUITING

Clinique Mutualiste La Sagesse

Rennes, 35043, France

RECRUITING

Policlinico Morgagni

Catania, 95125, Italy

RECRUITING

Campolongo Hospital

Eboli, 84025, Italy

RECRUITING

Circle Health Group

Reading, Berks, RG2 7AU, United Kingdom

RECRUITING

Yeovil District Hospital NHS Foundation Trust

Yeovil, Summerset, BA21 4AT, United Kingdom

RECRUITING

The Sulis Hospital Bath

Bath, BA2 8SQ, United Kingdom

RECRUITING

Bedford Hospital

Bedford, MK42 9DJ, United Kingdom

RECRUITING

Ipswich Hospital

Ipswich, IP4 5PD, United Kingdom

RECRUITING

Leicester General Hospital

Leicester, LE5 4PW, United Kingdom

RECRUITING

University Hospital South Manchester

Manchester, M23 9LT, United Kingdom

RECRUITING

Nottingham University Hospital

Nottingham, United Kingdom

RECRUITING

MeSH Terms

Conditions

Osteonecrosis; Rotator Cuff Injuries; Rotator Cuff Tear Arthropathy; Spondylitis, Ankylosing; Arthritis, Rheumatoid; Fractures, Bone; Infections

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Chondrocalcinosis; Arthritis; Joint Diseases; Crystal Arthropathies; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Ankylosis; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jonathan Wright, MD

  UF Health Orthopaedics and Sports Medicine Institute

  PRINCIPAL INVESTIGATOR

• Young Kwon, MD

  Hospital for Joint Diseases - NYU Langone Health

  PRINCIPAL INVESTIGATOR

• Richard Friedman, MD

  Charleston Orthopaedic Associates

  PRINCIPAL INVESTIGATOR

• Richard Jones, MD

  Southeastern Orthopedics and Spine

  PRINCIPAL INVESTIGATOR

• Howard Routman, DO

  Florida Atlantis Orthopaedics

  PRINCIPAL INVESTIGATOR

• Ryan Simovitch, MD

  Palm Beach Orthopaedic Institute

  PRINCIPAL INVESTIGATOR

• Geoffrey Abrams, MD

  Stanford Health Care

  PRINCIPAL INVESTIGATOR

• Pierre Henri Flurin, MD

  Centre de l'Arthrose

  PRINCIPAL INVESTIGATOR

• Yann Marczuk, MD

  Clinique Chenieux

  PRINCIPAL INVESTIGATOR

• Harry Brownlow, MD

  Circle Health Group

  PRINCIPAL INVESTIGATOR

• Oliver Donaldson, MD

  Yeovil District Hospital NHS Foundation

  PRINCIPAL INVESTIGATOR

• Chris Roberts, MD

  Ipswich Hospital

  PRINCIPAL INVESTIGATOR

• Chris Peach, MD

  University Hospital South Manchester

  PRINCIPAL INVESTIGATOR

• Angelo Di Giunta, MD

  Policlinico Morgagni

  PRINCIPAL INVESTIGATOR

• Alfonso Romano, MD

  Campolongo Hospital

  PRINCIPAL INVESTIGATOR

• Sean Grey, MD

  Orthopaedic and Spine Center of the Rockies

  PRINCIPAL INVESTIGATOR

• Chad Manke, MD

  Altantic Orthopaedics Specialists

  PRINCIPAL INVESTIGATOR

• Rick Papandrea, MD

  Orthopaedic Associates of Wisconsin

  PRINCIPAL INVESTIGATOR

• Andrew Chambler, MD

  The Sulis Hospital Bath

  PRINCIPAL INVESTIGATOR

• Curt Noel, MD

  Crystal Clinic Orthopaedic

  PRINCIPAL INVESTIGATOR

• Stephen Parada, MD

  Orthopedic and Sports Medicine

  PRINCIPAL INVESTIGATOR

• Ari Youderian, MD

  South County Orthopedic Specialists

  PRINCIPAL INVESTIGATOR

• Ian Byram, MD

  Bone and Joint Institute of Tennessee

  PRINCIPAL INVESTIGATOR

• Tewfik Benkalfate, MD

  Clinique Mutualiste la Sagesse

  PRINCIPAL INVESTIGATOR

• Peter McCann, MD

  Lenox Health Greenwich Village

  PRINCIPAL INVESTIGATOR

• Stephanie Muh, MD

  Henry Ford Health

  PRINCIPAL INVESTIGATOR

• Bradley Schoch, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Stephan Pill, MD

  Steadman Hawkins Clinic of the Carolinas

  PRINCIPAL INVESTIGATOR

• Scott Trenhaile, MD

  OrthoIllinois

  PRINCIPAL INVESTIGATOR

• Bryan Butler, MD

  Orthopaedic Medical Group of Tampa Bay

  PRINCIPAL INVESTIGATOR

• Ben Gooding, MD

  Nottingham City Hospital

  PRINCIPAL INVESTIGATOR

• Brad Carofino, MD

  Altantic Orthopaedics Specialist

  PRINCIPAL INVESTIGATOR

• Ben Sears, MD

  Western Orthopaedics

  PRINCIPAL INVESTIGATOR

• Kenneth Faber, MD

  St Joseph's Health Care

  PRINCIPAL INVESTIGATOR

• Jaicharan Iyengar, MD

  Alpine Orthopaedic Medical Group

  PRINCIPAL INVESTIGATOR

• Oke Anakwenze, MD

  Duke Department of Orthopedic Surgery

  PRINCIPAL INVESTIGATOR

• Thomas Obermeyer, MD

  Barrington Orthopedic

  PRINCIPAL INVESTIGATOR

• Alison Armstrong, MD

  Leicester General Hospital

  PRINCIPAL INVESTIGATOR

• George Malal, MD

  Bedford Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachael Craig

CONTACT

352-377-1140; rachael.craig@exac.com

Sandrine Angibaud

CONTACT

352-377-1140; sandrine.angibaud@exac.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: November 3, 2022
• Study Start: July 19, 2007
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2031
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

US (24); FR (3); IT (2); GB (8); CA (1)