Exactech Shoulder Post Market Clinical Follow-up Study

December 9, 2025 updated by: Exactech

An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Shoulder Arthroplasty Clinical and Radiographic Outcomes

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 4V2
        • Recruiting
        • St Joseph's Health Care
  • France
      • Limoges, France, 87039
        • Recruiting
        • Clinique Chenieux
        • Contact:
          • Estelle Tillet
          • Phone Number: 33 5 55 45 48 24
      • Mérignac, France, 33700
        • Recruiting
        • Centre de l'arthrose
        • Contact:
          • Diane Deplanque
          • Phone Number: 33 5 35 38 97 09
      • Rennes, France, 35043
        • Recruiting
        • Clinique Mutualiste La Sagesse
        • Contact:
          • Tewfik Benkalfate
          • Phone Number: 33 2 99 85 75 75
  • Italy
      • Catania, Italy, 95125
        • Recruiting
        • Policlinico Morgagni
        • Contact:
          • Gionacchino Zappulla
          • Phone Number: 39 095 238111
      • Eboli, Italy, 84025
        • Recruiting
        • Campolongo Hospital
        • Contact:
          • Francesco Ascione
          • Phone Number: 39 0828 348111
  • United Kingdom
      • Bath, United Kingdom, BA2 8SQ
        • Recruiting
        • The Sulis Hospital Bath
        • Contact:
          • Darren James
          • Phone Number: 01761 422222
      • Bedford, United Kingdom, MK42 9DJ
        • Recruiting
        • Bedford Hospital
      • Ipswich, United Kingdom, IP4 5PD
        • Recruiting
        • Ipswich Hospital
        • Contact:
          • David B Smith
          • Phone Number: 01473 712233
      • Leicester, United Kingdom, LE5 4PW
        • Recruiting
        • Leicester General Hospital
      • Manchester, United Kingdom, M23 9LT
        • Recruiting
        • University Hospital South Manchester
        • Contact:
          • Rebecca Carter
          • Phone Number: 0161 945 8203
      • Nottingham, United Kingdom
        • Recruiting
        • Nottingham University Hospital
        • Contact:
          • Donna King
          • Phone Number: 0115 924 9924
    • Berks
      • Reading, Berks, United Kingdom, RG2 7AU
        • Recruiting
        • Circle Health Group
        • Contact:
          • Richard Forbes
          • Phone Number: 0118 922 6888
    • Summerset
      • Yeovil, Summerset, United Kingdom, BA21 4AT
        • Recruiting
        • Yeovil District Hospital NHS Foundation Trust
        • Contact:
          • Oliver Donaldson
          • Phone Number: 01935 475122
  • United States
    • California
      • Laguna Woods, California, United States, 92637
        • Recruiting
        • South County Orthopedic Specialists
        • Contact:
          • Phone Number: 949-586-3200
      • Redwood City, California, United States, 94063
        • Recruiting
        • Stanford Health Care
        • Contact:
          • Anna Ramakrishnan
          • Phone Number: 650-723-5643
      • Stockton, California, United States, 95204-5508
        • Recruiting
        • Alpine Orthopaedic Medical Group
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Western Orthopaedics
        • Contact:
          • Libby Mauter
          • Phone Number: 303-321-1333
      • Fort Collins, Colorado, United States, 80525
        • Recruiting
        • Orthopaedic and Spine Center of the Rockies
        • Contact:
          • Josh Orr
          • Phone Number: 940-419-7050
    • Florida
      • Gainesville, Florida, United States, 32607
        • Recruiting
        • UF Health Orthopaedics and Sports Medicine Institute
        • Contact:
          • Aimee Struk
          • Phone Number: 352-273-7001
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic
        • Contact:
          • Jennnifer Wirtz
          • Phone Number: 904-953-2000
      • Palm Beach Gardens, Florida, United States, 33401
        • Recruiting
        • Palm Beach Orthopaedic Institute
        • Contact:
          • Meg Ryan
          • Phone Number: 561-657-4610
      • Palm Beach Gardens, Florida, United States, 33410
        • Recruiting
        • Florida Atlantis Orthopedics
        • Contact:
          • Rachel Routman
          • Phone Number: 561-627-8500
      • Tampa, Florida, United States, 33619
        • Recruiting
        • Orthopaedic Medical Group of Tampa Bay
        • Contact:
          • Kendra Richerdson
          • Phone Number: 813-684-2663
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Recruiting
        • Orthopedic and Sports Medicine
        • Contact:
          • Elizabeth Barker
          • Phone Number: 706-223-1493
    • Illinois
      • Rockford, Illinois, United States, 61107
        • Recruiting
        • OrthoIllinois
        • Contact:
          • Timothy Nelligan
          • Phone Number: 815-398-9491
      • Schaumburg, Illinois, United States, 60195
        • Recruiting
        • Barrington Orthpedic Specialists
    • Michigan
      • Detroit, Michigan, United States, 48067
        • Recruiting
        • Henry Ford Health
        • Contact:
          • Johnny Kasto
          • Phone Number: 800-436-7936
    • New York
      • New York, New York, United States, 10011
        • Recruiting
        • Lenox Health Greenwich Village
        • Contact:
          • Johnathan Joseph
          • Phone Number: 646-665-6000
      • New York, New York, United States, 10003
        • Recruiting
        • Hospital for Joint Diseases - NYU Langone Health
        • Contact:
          • Phone Number: 212-598-6000
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Recruiting
        • Southeastern Sports Medicine and Orthopedics
        • Contact:
          • Rebecca Rathbone
          • Phone Number: 828-274-4555
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke Department of Orthopedic Surgery
    • Ohio
      • Akron, Ohio, United States, 44333
        • Recruiting
        • Crystal Clinic Orthopaedic
        • Contact:
          • Ginny Texter
          • Phone Number: 330-668-4040
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Recruiting
        • Charleston Orthopaedic Associates
        • Contact:
          • Lisa Mock
          • Phone Number: 843-769-2000
      • Greenville, South Carolina, United States, 29615
        • Recruiting
        • Steadman Hawkins Clinic of the Carolinas
        • Contact:
          • Kyle Adams
          • Phone Number: 864-454-7422
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Recruiting
        • Bone and Joint Institute of Tenessee
        • Contact:
          • Kristin Freeman
          • Phone Number: 615-791-2630
    • Virginia
      • Virginia Beach, Virginia, United States, 23320
        • Recruiting
        • Atlantic Orthopaedics Specialists
        • Contact:
          • Brice Snyder
          • Phone Number: 757-321-3300
    • Wisconsin
      • Pewaukee, Wisconsin, United States, 53072
        • Recruiting
        • Orthopaedic Associates of Wisconsin
        • Contact:
          • Ryann Hamm
          • Phone Number: 262-303-5055

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who meet eligibility criteria - Patients who consent to participate to return for follow-up visits out to 10 years or longer

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Constant
Time Frame: 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
Through study completion, an average of 1 per year
ASES
Time Frame: 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
Through study completion, an average of 1 per year
Oxford Score (may be used as an optional form for surgeons in the United Kingdom)
Time Frame: 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
Through study completion, an average of 1 per year
TESS (may be used as specific forms related to the pre-operative condition/diagnosis)
Time Frame: 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
Through study completion, an average of 1 per year
MSTS (may be used as specific forms related to the pre-operative condition/diagnosis)
Time Frame: 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
Through study completion, an average of 1 per year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Exactech

Investigators

  • Principal Investigator: Jonathan Wright, MD, UF Health Orthopaedics and Sports Medicine Institute
  • Principal Investigator: Young Kwon, MD, Hospital for Joint Diseases - NYU Langone Health
  • Principal Investigator: Richard Friedman, MD, Charleston Orthopaedic Associates
  • Principal Investigator: Howard Routman, DO, Florida Atlantis Orthopaedics
  • Principal Investigator: Ryan Simovitch, MD, Palm Beach Orthopaedic Institute
  • Principal Investigator: Geoffrey Abrams, MD, Stanford Health Care
  • Principal Investigator: Pierre Henri Flurin, MD, Centre de l'arthrose
  • Principal Investigator: Yann Marczuk, MD, Clinique Chenieux
  • Principal Investigator: Harry Brownlow, MD, Circle Health Group
  • Principal Investigator: Oliver Donaldson, MD, Yeovil District Hospital NHS Foundation
  • Principal Investigator: Chris Peach, MD, University Hospital South Manchester
  • Principal Investigator: Angelo Di Giunta, MD, Policlinico Morgagni
  • Principal Investigator: Alfonso Romano, MD, Campolongo Hospital
  • Principal Investigator: Sean Grey, MD, Orthopaedic and Spine Center of the Rockies
  • Principal Investigator: Chad Manke, MD, Altantic Orthopaedics Specialists
  • Principal Investigator: Rick Papandrea, MD, Orthopaedic Associates of Wisconsin
  • Principal Investigator: Andrew Chambler, MD, The Sulis Hospital Bath
  • Principal Investigator: Curt Noel, MD, Crystal Clinic Orthopaedic
  • Principal Investigator: Stephen Parada, MD, Orthopedic and Sports Medicine
  • Principal Investigator: Ari Youderian, MD, South County Orthopedic Specialists
  • Principal Investigator: Ian Byram, MD, Bone and Joint Institute of Tennessee
  • Principal Investigator: Tewfik Benkalfate, MD, Clinique Mutualiste La Sagesse
  • Principal Investigator: Peter McCann, MD, Lenox Health Greenwich Village
  • Principal Investigator: Stephanie Muh, MD, Henry Ford Health
  • Principal Investigator: Stephan Pill, MD, Steadman Hawkins Clinic of the Carolinas
  • Principal Investigator: Scott Trenhaile, MD, OrthoIllinois
  • Principal Investigator: Bryan Butler, MD, Orthopaedic Medical Group of Tampa Bay
  • Principal Investigator: Brad Carofino, MD, Altantic Orthopaedics Specialist
  • Principal Investigator: Ben Sears, MD, Western Orthopaedics
  • Principal Investigator: Bradley Schoch, MD, Mayo Clinic
  • Principal Investigator: Richard Jones, MD, Southeastern Orthopedics and Spine
  • Principal Investigator: Chris Roberts, MD, Ipswich Hospital
  • Principal Investigator: Ben Gooding, MD, Nottingham City Hospital
  • Principal Investigator: Kenneth Faber, MD, St Joseph's Health Care
  • Principal Investigator: Jaicharan Iyengar, MD, Alpine Orthopaedic Medical Group
  • Principal Investigator: Oke Anakwenze, MD, Duke Department of Orthopedic Surgery
  • Principal Investigator: Thomas Obermeyer, MD, Barrington Orthopedic
  • Principal Investigator: Alison Armstrong, MD, Leicester General Hospital
  • Principal Investigator: George Malal, MD, Bedford Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2007

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2031

Study Registration Dates

First Submitted

October 25, 2022

First Submitted That Met QC Criteria

November 1, 2022

First Posted (Actual)

November 3, 2022

Study Record Updates

Last Update Posted (Estimated)

December 15, 2025

Last Update Submitted That Met QC Criteria

December 9, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR09-005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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