Exactech Shoulder Post Market Clinical Follow-up Study

Recruiting

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

• Registration Number: NCT05603728
• Lead Sponsor: Exactech

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2022-10-25
• Study First Submitted QC: 2022-11-01
• Study First Posted: 2022-11-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28
• Primary Completion: 2030-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20000

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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
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
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

Trial Locations

Locations (38)

Clinique Mutualiste La Sagesse; 🇫🇷 Rennes, France

Circle Health Group; 🇬🇧 Reading, Berks, United Kingdom

Policlinico Morgagni; 🇮🇹 Catania, Italy

Campolongo Hospital; 🇮🇹 Eboli, Italy

Alpine Orthopaedic Medical Group; 🇺🇸 Stockton, California, United States

Barrington Orthpedic Specialists; 🇺🇸 Schaumburg, Illinois, United States

Duke Department of Orthopedic Surgery; 🇺🇸 Durham, North Carolina, United States

St Joseph's Health Care; 🇨🇦 London, Ontario, Canada

Bedford Hospital; 🇬🇧 Bedford, United Kingdom

Leicester General Hospital; 🇬🇧 Leicester, United Kingdom

South County Orthopedic Specialists; 🇺🇸 Laguna Woods, California, United States

Stanford Health Care; 🇺🇸 Redwood City, California, United States

Western Orthopaedics; 🇺🇸 Denver, Colorado, United States

Orthopaedic and Spine Center of the Rockies; 🇺🇸 Fort Collins, Colorado, United States

UF Health Orthopaedics and Sports Medicine Institute; 🇺🇸 Gainesville, Florida, United States

Mayo Clinic; 🇺🇸 Jacksonville, Florida, United States

Palm Beach Orthopaedic Institute; 🇺🇸 Palm Beach Gardens, Florida, United States

Florida Atlantis Orthopedics; 🇺🇸 Palm Beach Gardens, Florida, United States

Orthopaedic Medical Group of Tampa Bay; 🇺🇸 Tampa, Florida, United States

Orthopedic and Sports Medicine; 🇺🇸 Augusta, Georgia, United States

OrthoIllinois; 🇺🇸 Rockford, Illinois, United States

Henry Ford Health; 🇺🇸 Detroit, Michigan, United States

Hospital for Joint Diseases - NYU Langone Health; 🇺🇸 New York, New York, United States

Lenox Health Greenwich Village; 🇺🇸 New York, New York, United States

Southeastern Sports Medicine and Orthopedics; 🇺🇸 Asheville, North Carolina, United States

Crystal Clinic Orthopaedic; 🇺🇸 Akron, Ohio, United States

Charleston Orthopaedic Associates; 🇺🇸 Charleston, South Carolina, United States

Steadman Hawkins Clinic of the Carolinas; 🇺🇸 Greenville, South Carolina, United States

Bone and Joint Institute of Tenessee; 🇺🇸 Franklin, Tennessee, United States

Atlantic Orthopaedics Specialists; 🇺🇸 Virginia Beach, Virginia, United States

Orthopaedic Associates of Wisconsin; 🇺🇸 Pewaukee, Wisconsin, United States

Clinique Chenieux; 🇫🇷 Limoges, France

Centre de l'arthrose; 🇫🇷 Mérignac, France

Yeovil District Hospital NHS Foundation Trust; 🇬🇧 Yeovil, Summerset, United Kingdom

The Sulis Hospital Bath; 🇬🇧 Bath, United Kingdom

Ipswich Hospital; 🇬🇧 Ipswich, United Kingdom

University Hospital South Manchester; 🇬🇧 Manchester, United Kingdom

Nottingham University Hospital; 🇬🇧 Nottingham, United Kingdom