Exactech Shoulder Post Market Clinical Follow-up Study

This study is observing people who have had or will have shoulder arthroplasty (shoulder replacement surgery) to understand how well the Exactech shoulder replacement works over a long time. It aims to collect information on its safety and performance. You might be able to join if you are at least 21 years old, are expected to live for at least two more years, and are willing to attend follow-up visits. The study will measure your shoulder function and pain using scores like the Constant and ASES scores to see how well the shoulder replacement is performing. The current recruitment status is unclear.

Study design
This is an observational study, meaning researchers will collect information without giving you a specific treatment. It plans to include 20,000 participants.
What's involved
You would need to attend pre- and postoperative visits and comply with their requirements. The study will follow you for a minimum of 10 years, with no early end date.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for a minimum of 10 years, and potentially longer, with assessments like Constant and ASES scores measured about once a year throughout the study.

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NCT05603728

Exactech Shoulder Post Market Clinical Follow-up Study

Recruiting
Not specifiedAges 21+Observational
Exactech
~20,000 participants
Updated 2025-12-15 on ClinicalTrials.gov

At a glance

Recruiting sites
38 of 38 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Constant
Measured over Through study completion, an average of 1 per year
+4 more outcomes measured
Osteo Arthritis Shoulders
Osteonecrosis
Rotator Cuff Tears
Rotator Cuff Tear Arthropathy
Ankylosing Spondylitis
Post-traumatic Osteoarthritis
Rheumatoid Arthritis
Fracture
Infections
38 sites across 19 states
United Kingdom6
Florida5
California3
France3
Colorado2
Illinois2
New York2
North Carolina2
  • Jonathan Wright, MD · PRINCIPAL_INVESTIGATOR · UF Health Orthopaedics and Sports Medicine Institute
  • Young Kwon, MD · PRINCIPAL_INVESTIGATOR · Hospital for Joint Diseases - NYU Langone Health
  • Richard Friedman, MD · PRINCIPAL_INVESTIGATOR · Charleston Orthopaedic Associates
  • Richard Jones, MD · PRINCIPAL_INVESTIGATOR · Southeastern Orthopedics and Spine
  • Howard Routman, DO · PRINCIPAL_INVESTIGATOR · Florida Atlantis Orthopaedics
  • Ryan Simovitch, MD · PRINCIPAL_INVESTIGATOR · Palm Beach Orthopaedic Institute
  • Geoffrey Abrams, MD · PRINCIPAL_INVESTIGATOR · Stanford Health Care
  • Pierre Henri Flurin, MD · PRINCIPAL_INVESTIGATOR · Centre de l'Arthrose
  • Yann Marczuk, MD · PRINCIPAL_INVESTIGATOR · Clinique Chenieux
  • Harry Brownlow, MD · PRINCIPAL_INVESTIGATOR · Circle Health Group
  • Oliver Donaldson, MD · PRINCIPAL_INVESTIGATOR · Yeovil District Hospital NHS Foundation
  • Chris Roberts, MD · PRINCIPAL_INVESTIGATOR · Ipswich Hospital
  • Chris Peach, MD · PRINCIPAL_INVESTIGATOR · University Hospital South Manchester
  • Angelo Di Giunta, MD · PRINCIPAL_INVESTIGATOR · Policlinico Morgagni
  • Alfonso Romano, MD · PRINCIPAL_INVESTIGATOR · Campolongo Hospital
  • Sean Grey, MD · PRINCIPAL_INVESTIGATOR · Orthopaedic and Spine Center of the Rockies
  • Chad Manke, MD · PRINCIPAL_INVESTIGATOR · Altantic Orthopaedics Specialists
  • Rick Papandrea, MD · PRINCIPAL_INVESTIGATOR · Orthopaedic Associates of Wisconsin
  • Andrew Chambler, MD · PRINCIPAL_INVESTIGATOR · The Sulis Hospital Bath
  • Curt Noel, MD · PRINCIPAL_INVESTIGATOR · Crystal Clinic Orthopaedic
  • Stephen Parada, MD · PRINCIPAL_INVESTIGATOR · Orthopedic and Sports Medicine
  • Ari Youderian, MD · PRINCIPAL_INVESTIGATOR · South County Orthopedic Specialists
  • Ian Byram, MD · PRINCIPAL_INVESTIGATOR · Bone and Joint Institute of Tennessee
  • Tewfik Benkalfate, MD · PRINCIPAL_INVESTIGATOR · Clinique Mutualiste la Sagesse
  • Peter McCann, MD · PRINCIPAL_INVESTIGATOR · Lenox Health Greenwich Village
  • Stephanie Muh, MD · PRINCIPAL_INVESTIGATOR · Henry Ford Health
  • Bradley Schoch, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic
  • Stephan Pill, MD · PRINCIPAL_INVESTIGATOR · Steadman Hawkins Clinic of the Carolinas
  • Scott Trenhaile, MD · PRINCIPAL_INVESTIGATOR · OrthoIllinois
  • Bryan Butler, MD · PRINCIPAL_INVESTIGATOR · Orthopaedic Medical Group of Tampa Bay
  • Ben Gooding, MD · PRINCIPAL_INVESTIGATOR · Nottingham City Hospital
  • Brad Carofino, MD · PRINCIPAL_INVESTIGATOR · Altantic Orthopaedics Specialist
  • Ben Sears, MD · PRINCIPAL_INVESTIGATOR · Western Orthopaedics
  • Kenneth Faber, MD · PRINCIPAL_INVESTIGATOR · St Joseph's Health Care
  • Jaicharan Iyengar, MD · PRINCIPAL_INVESTIGATOR · Alpine Orthopaedic Medical Group
  • Oke Anakwenze, MD · PRINCIPAL_INVESTIGATOR · Duke Department of Orthopedic Surgery
  • Thomas Obermeyer, MD · PRINCIPAL_INVESTIGATOR · Barrington Orthopedic
  • Alison Armstrong, MD · PRINCIPAL_INVESTIGATOR · Leicester General Hospital
  • George Malal, MD · PRINCIPAL_INVESTIGATOR · Bedford Hospital

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Eligibility criteria

Inclusion

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

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)
  • ConstantThrough study completion, an average of 1 per year

    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

  • ASESThrough study completion, an average of 1 per year

    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

  • Oxford Score (may be used as an optional form for surgeons in the United Kingdom)Through study completion, an average of 1 per year

    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

  • TESS (may be used as specific forms related to the pre-operative condition/diagnosis)Through study completion, an average of 1 per year

    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

  • MSTS (may be used as specific forms related to the pre-operative condition/diagnosis)Through study completion, an average of 1 per year

    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