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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Exactech Shoulder Post Market Clinical Follow-up Study
At a glance
Conditions
Where it's being run
38 sites across 19 statesStudy leadership
- 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
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- 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