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Recruiting Observational

Exactech Shoulder Post Market Clinical Follow-up Study

NCT05603728 · tracked via the Priya Life Science UK tracker
Sponsor
Phase
Observational
Started
2007-07-19
Last updated
2026-09-17

Condition(s) studied

Osteo Arthritis ShouldersOsteonecrosisRotator Cuff TearsRotator Cuff Tear ArthropathyAnkylosing SpondylitisPost-traumatic OsteoarthritisRheumatoid ArthritisFractureInfections

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

Sex
ALL
Min age
21 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Constant — Through 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
  • ASES — Through 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

Trial sites (40)

FacilityCityRegionStatus
South County Orthopedic Specialists Laguna Woods California Recruiting
Stanford Health Care Redwood City California Recruiting
Alpine Orthopaedic Medical Group Stockton California Recruiting
Western Orthopaedics Denver Colorado Recruiting
Orthopaedic and Spine Center of the Rockies Fort Collins Colorado Recruiting
UF Health Orthopaedics and Sports Medicine Institute Gainesville Florida Recruiting
Mayo Clinic Jacksonville Florida Recruiting
Florida Atlantis Orthopedics Palm Beach Gardens Florida Recruiting
Orthopaedic Medical Group of Tampa Bay Tampa Florida Recruiting
HSS Florida West Palm Beach Florida Recruiting
Orthopedic and Sports Medicine Augusta Georgia Recruiting
OrthoIllinois Rockford Illinois Recruiting
Barrington Orthpedic Specialists Schaumburg Illinois Recruiting
Henry Ford Health Detroit Michigan Recruiting
Hospital for Joint Diseases - NYU Langone Health New York New York Recruiting
Lenox Health Greenwich Village New York New York Recruiting
Southeastern Sports Medicine and Orthopedics Asheville North Carolina Recruiting
Duke Department of Orthopedic Surgery Durham North Carolina Recruiting
Crystal Clinic Orthopaedic Akron Ohio Recruiting
Charleston Orthopaedic Associates Charleston South Carolina Recruiting
Steadman Hawkins Clinic of the Carolinas Greenville South Carolina Recruiting
Bone and Joint Institute of Tenessee Franklin Tennessee Recruiting
Atlantic Orthopaedics Specialists Virginia Beach Virginia Recruiting
Orthopaedic Associates of Wisconsin Pewaukee Wisconsin Recruiting
St Joseph's Health Care London Ontario Recruiting
Clinique Belledone Grenoble France Recruiting
Centre de l'arthrose Mérignac France Recruiting
Clinique Mutualiste La Sagesse Rennes France Recruiting
Malteser Waldkrankenhaus Erlangen Erlangen Germany Recruiting
Orthopadische Praxisklinik Von Vincke Münster Germany Recruiting
Policlinico Morgagni Catania Italy Recruiting
Campolongo Hospital Eboli Italy Recruiting
Circle Health Group Reading Berks Recruiting
Yeovil District Hospital NHS Foundation Trust Yeovil Summerset Recruiting
The Sulis Hospital Bath Bath United Kingdom Recruiting
Bedford Hospital Bedford United Kingdom Recruiting
Ipswich Hospital Ipswich United Kingdom Recruiting
Leicester General Hospital Leicester United Kingdom Recruiting
University Hospital South Manchester Manchester United Kingdom Recruiting
Nottingham University Hospital Nottingham United Kingdom Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05603728 on ClinicalTrials.gov ↗ ← All trials in the UK