Actively Recruiting
Open Label Multi-Center Study Evaluating Long-Term Clinical and Radiographic Outcomes of Shoulder Arthroplasty
Led by Exactech · Updated on 2025-12-15
20000
Participants Needed
38
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are collecting and evaluating long-term clinical and X-ray data to better understand the safety and performance of shoulder arthroplasty over time. This observational study follows patients for at least 10 years to observe outcomes without a set limit on follow-up duration. The study includes people with various shoulder conditions such as osteoarthritis, rotator cuff tears, fractures, and infections. Participants in this study have undergone or are indicated for shoulder arthroplasty surgery. The study tracks their progress over time through regular clinical and radiographic assessments. Various outcome scores like the Constant score, ASES, Oxford Score, TESS, and MSTS are measured approximately once per year throughout the study period to evaluate shoulder function and recovery. During the study, participants will attend scheduled visits where clinical exams and imaging are performed to monitor their shoulder health and prosthesis performance. They will complete questionnaires related to their condition and function. The study aims to gather comprehensive long-term data on shoulder arthroplasty outcomes, with follow-up lasting at least 10 years from enrollment.
CONDITIONS
Brief Title
Exactech Shoulder Post Market Clinical Follow-up Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is indicated for shoulder arthroplasty or has previously undergone shoulder arthroplasty
- Patient is skeletally mature
- Patient is expected to survive at least 2 years beyond surgery
- Patient is willing to comply with pre- and postoperative visit requirements
- Patient can read and sign an informed consent form
You will not qualify if you...
- Osteomyelitis of the proximal humerus or scapula or systemic infection
- Bone inadequate for prosthesis support or fixation
- Medial humeral bone loss compromising stem fixation
- Proximal humeral bone loss extending beyond surgical neck compromising fixation
- Neuromuscular disorders preventing joint control
- Significant brachial plexus injury
- Non-functional deltoid muscles
- Age, weight, or activity level predicting early implant failure
- Inability or unwillingness to comply with post-operative care
- Alcohol, drug, or substance abuse
- Any disease affecting implant function or longevity
- Pregnancy
- Prisoner status
- Contraindication for surgery
- Revision with stemmed humeral component (Stemless Shoulder System)
- Metal allergy or sensitivity to implant materials (Stemless Shoulder System)
- Acute proximal humerus fractures with displacement or failed glenohumeral joint (Stemless Shoulder System)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 years
Participants who have undergone shoulder arthroplasty are observed to evaluate clinical and radiographic outcomes over time.
Approximately 1 visit per year
Trial Site Locations
Total: 38 locations
1
South County Orthopedic Specialists
Laguna Woods, California, United States, 92637
Actively Recruiting
2
Stanford Health Care
Redwood City, California, United States, 94063
Actively Recruiting
3
Alpine Orthopaedic Medical Group
Stockton, California, United States, 95204-5508
Actively Recruiting
4
Western Orthopaedics
Denver, Colorado, United States, 80218
Actively Recruiting
5
Orthopaedic and Spine Center of the Rockies
Fort Collins, Colorado, United States, 80525
Actively Recruiting
6
UF Health Orthopaedics and Sports Medicine Institute
Gainesville, Florida, United States, 32607
Actively Recruiting
7
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
8
Palm Beach Orthopaedic Institute
Palm Beach Gardens, Florida, United States, 33401
Actively Recruiting
9
Florida Atlantis Orthopedics
Palm Beach Gardens, Florida, United States, 33410
Actively Recruiting
10
Orthopaedic Medical Group of Tampa Bay
Tampa, Florida, United States, 33619
Actively Recruiting
11
Orthopedic and Sports Medicine
Augusta, Georgia, United States, 30909
Actively Recruiting
12
OrthoIllinois
Rockford, Illinois, United States, 61107
Actively Recruiting
13
Barrington Orthpedic Specialists
Schaumburg, Illinois, United States, 60195
Actively Recruiting
14
Henry Ford Health
Detroit, Michigan, United States, 48067
Actively Recruiting
15
Hospital for Joint Diseases - NYU Langone Health
New York, New York, United States, 10003
Actively Recruiting
16
Lenox Health Greenwich Village
New York, New York, United States, 10011
Actively Recruiting
17
Southeastern Sports Medicine and Orthopedics
Asheville, North Carolina, United States, 28803
Actively Recruiting
18
Duke Department of Orthopedic Surgery
Durham, North Carolina, United States, 27705
Actively Recruiting
19
Crystal Clinic Orthopaedic
Akron, Ohio, United States, 44333
Actively Recruiting
20
Charleston Orthopaedic Associates
Charleston, South Carolina, United States, 29414
Actively Recruiting
21
Steadman Hawkins Clinic of the Carolinas
Greenville, South Carolina, United States, 29615
Actively Recruiting
22
Bone and Joint Institute of Tenessee
Franklin, Tennessee, United States, 37067
Actively Recruiting
23
Atlantic Orthopaedics Specialists
Virginia Beach, Virginia, United States, 23320
Actively Recruiting
24
Orthopaedic Associates of Wisconsin
Pewaukee, Wisconsin, United States, 53072
Actively Recruiting
25
St Joseph's Health Care
London, Ontario, Canada, N6A 4V2
Actively Recruiting
26
Clinique Chenieux
Limoges, France, 87039
Actively Recruiting
27
Centre de l'arthrose
Mérignac, France, 33700
Actively Recruiting
28
Clinique Mutualiste La Sagesse
Rennes, France, 35043
Actively Recruiting
29
Policlinico Morgagni
Catania, Italy, 95125
Actively Recruiting
30
Campolongo Hospital
Eboli, Italy, 84025
Actively Recruiting
31
Circle Health Group
Reading, Berks, United Kingdom, RG2 7AU
Actively Recruiting
32
Yeovil District Hospital NHS Foundation Trust
Yeovil, Summerset, United Kingdom, BA21 4AT
Actively Recruiting
33
The Sulis Hospital Bath
Bath, United Kingdom, BA2 8SQ
Actively Recruiting
34
Bedford Hospital
Bedford, United Kingdom, MK42 9DJ
Actively Recruiting
35
Ipswich Hospital
Ipswich, United Kingdom, IP4 5PD
Actively Recruiting
36
Leicester General Hospital
Leicester, United Kingdom, LE5 4PW
Actively Recruiting
37
University Hospital South Manchester
Manchester, United Kingdom, M23 9LT
Actively Recruiting
38
Nottingham University Hospital
Nottingham, United Kingdom
Actively Recruiting
Research Team
R
Rachael Craig
S
Sandrine Angibaud
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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