Actively Recruiting

Age: 21Years +
All Genders
NCT05603728

Exactech Shoulder Post Market Clinical Follow-up Study

Led by Exactech · Updated on 2025-12-15

20000

Participants Needed

38

Research Sites

1275 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Exactech Shoulder Post Market Clinical Follow-up Study

Who Can Participate

Age: 21Years +
All Genders

Eligibility Criteria

Eligible

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 is willing and able to read and sign informed consent
Not Eligible

You will not qualify if you...

  • Osteomyelitis of the proximal humerus or scapula, or systemic/remote infection
  • Inadequate or malformed bone preventing prosthesis fixation
  • Medial humeral bone loss compromising stem fixation
  • Proximal humeral bone loss extending distal to surgical neck compromising stem fixation
  • Neuromuscular disorders preventing joint control
  • Significant brachial plexus injury
  • Non-functional deltoid muscles
  • Age, weight, or activity level causing expected early implant failure
  • Unwilling or unable to follow post-operative care instructions
  • Alcohol, drug, or substance abuse
  • Any disease affecting implant function or longevity
  • Pregnancy
  • Prisoner status
  • Contraindication for surgery
  • Revision cases with stemmed humeral component (Stemless Shoulder System)
  • Metal allergy or sensitivity to implant materials (Stemless Shoulder System)
  • Acute proximal humerus fractures with displacement or failure of shoulder joint (Stemless Shoulder System)
  • Acute proximal humerus fractures combined with degenerative joint disease and irreparable rotator cuff (Stemless Shoulder System)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

R

Rachael Craig

CONTACT

S

Sandrine Angibaud

CONTACT

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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