ClinicalTrials.gg
RecruitingNCT05603728Updated Sep 17, 2026

Exactech Shoulder Post Market Clinical Follow-up Study

An observational study in Osteo Arthritis Shoulders, Osteonecrosis and Rotator Cuff Tears, sponsored by Exactech. Recruiting at 40 sites in 6 countries. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Exactech · Observational

From the registry’s dates

  • Started Jul 2007; still recruiting 19 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
20,000
Ages
21 Years and older
Sex
All
01

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.

02

Conditions studied

  • Osteo Arthritis Shoulders
  • Osteonecrosis
  • Rotator Cuff Tears
  • Rotator Cuff Tear Arthropathy
  • Ankylosing Spondylitis
  • Post-traumatic Osteoarthritis
  • Rheumatoid Arthritis
  • Fracture
  • Infections
03

In context

Osteonecrosis

286 studies on the registry are indexed under Osteonecrosis; 45 are open to participants now.

This study's planned enrollment of 20,000 is above the median of 121 across 127 observational studies indexed under Osteonecrosis.

Browse Osteonecrosis studies →

Lead sponsor

Exactech is the lead sponsor of 17 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form

Exclusion criteria

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 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)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
20,000 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Constant

    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

    Time frame: Through study completion, an average of 1 per year

  2. ASES

    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

    Time frame: Through study completion, an average of 1 per year

  3. Oxford Score (may be used as an optional form for surgeons in the United Kingdom)

    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

    Time frame: Through study completion, an average of 1 per year

  4. TESS (may be used as specific forms related to the pre-operative condition/diagnosis)

    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

    Time frame: Through study completion, an average of 1 per year

  5. MSTS (may be used as specific forms related to the pre-operative condition/diagnosis)

    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

    Time frame: Through study completion, an average of 1 per year

07

Study locations

40 of 40 sites recruiting
  • South County Orthopedic Specialists
    Laguna Woods, California 92637, United States
    Recruiting
    • · Contact949-586-3200
  • Stanford Health Care
    Redwood City, California 94063, United States
    Recruiting
    • Anna Ramakrishnan · Contact650-723-5643
  • Alpine Orthopaedic Medical Group
    Stockton, California 95204-5508, United States
    Recruiting
  • Western Orthopaedics
    Denver, Colorado 80218, United States
    Recruiting
    • Libby Mauter · Contact303-321-1333
  • Orthopaedic and Spine Center of the Rockies
    Fort Collins, Colorado 80525, United States
    Recruiting
    • Josh Orr · Contact940-419-7050
  • UF Health Orthopaedics and Sports Medicine Institute
    Gainesville, Florida 32607, United States
    Recruiting
    • Aimee Struk · Contact352-273-7001
  • Mayo Clinic
    Jacksonville, Florida 32224, United States
    Recruiting
    • Jennnifer Wirtz · Contact904-953-2000
  • Florida Atlantis Orthopedics
    Palm Beach Gardens, Florida 33410, United States
    Recruiting
    • Rachel Routman · Contact561-627-8500
  • Orthopaedic Medical Group of Tampa Bay
    Tampa, Florida 33619, United States
    Recruiting
    • Kendra Richerdson · Contact813-684-2663
  • HSS Florida
    West Palm Beach, Florida 33401, United States
    Recruiting
    • Meg Ryan · Contact561-657-4610
  • Orthopedic and Sports Medicine
    Augusta, Georgia 30909, United States
    Recruiting
    • Elizabeth Barker · Contact706-223-1493
  • OrthoIllinois
    Rockford, Illinois 61107, United States
    Recruiting
    • Timothy Nelligan · Contact815-398-9491
  • Barrington Orthpedic Specialists
    Schaumburg, Illinois 60195, United States
    Recruiting
  • Henry Ford Health
    Detroit, Michigan 48067, United States
    Recruiting
    • Johnny Kasto · Contact800-436-7936
  • Hospital for Joint Diseases - NYU Langone Health
    New York, New York 10003, United States
    Recruiting
    • · Contact212-598-6000
  • Lenox Health Greenwich Village
    New York, New York 10011, United States
    Recruiting
    • Johnathan Joseph · Contact646-665-6000
  • Southeastern Sports Medicine and Orthopedics
    Asheville, North Carolina 28803, United States
    Recruiting
    • Rebecca Rathbone · Contact828-274-4555
  • Duke Department of Orthopedic Surgery
    Durham, North Carolina 27705, United States
    Recruiting
  • Crystal Clinic Orthopaedic
    Akron, Ohio 44333, United States
    Recruiting
    • Ginny Texter · Contact330-668-4040
  • Charleston Orthopaedic Associates
    Charleston, South Carolina 29414, United States
    Recruiting
    • Lisa Mock · Contact843-769-2000
  • Steadman Hawkins Clinic of the Carolinas
    Greenville, South Carolina 29615, United States
    Recruiting
    • Kyle Adams · Contact864-454-7422
  • Bone and Joint Institute of Tenessee
    Franklin, Tennessee 37067, United States
    Recruiting
    • Kristin Freeman · Contact615-791-2630
  • Atlantic Orthopaedics Specialists
    Virginia Beach, Virginia 23320, United States
    Recruiting
    • Brice Snyder · Contact757-321-3300
  • Orthopaedic Associates of Wisconsin
    Pewaukee, Wisconsin 53072, United States
    Recruiting
    • Ryann Hamm · Contact262-303-5055
  • St Joseph's Health Care
    London, Ontario N6A 4V2, Canada
    Recruiting
  • Clinique Belledone
    Grenoble, 38000, France
    Recruiting
    • · Contact+33 4 76 54 40 79
  • Centre de l'arthrose
    Mérignac, 33700, France
    Recruiting
    • Diane Deplanque · Contact33 5 35 38 97 09
  • Clinique Mutualiste La Sagesse
    Rennes, 35043, France
    Recruiting
    • Tewfik Benkalfate · Contact33 2 99 85 75 75
  • Malteser Waldkrankenhaus Erlangen
    Erlangen, 91054, Germany
    Recruiting
    • · Contact+49 9131 8220
  • Orthopadische Praxisklinik Von Vincke
    Münster, 48143, Germany
    Recruiting
    • · Contact+49 251 5395960
  • Policlinico Morgagni
    Catania, 95125, Italy
    Recruiting
    • Gionacchino Zappulla · Contact39 095 238111
  • Campolongo Hospital
    Eboli, 84025, Italy
    Recruiting
    • Francesco Ascione · Contact39 0828 348111
  • Circle Health Group
    Reading, Berks RG2 7AU, United Kingdom
    Recruiting
    • Richard Forbes · Contact0118 922 6888
  • Yeovil District Hospital NHS Foundation Trust
    Yeovil, Summerset BA21 4AT, United Kingdom
    Recruiting
    • Oliver Donaldson · Contact01935 475122
  • The Sulis Hospital Bath
    Bath, BA2 8SQ, United Kingdom
    Recruiting
    • Darren James · Contact01761 422222
  • Bedford Hospital
    Bedford, MK42 9DJ, United Kingdom
    Recruiting
  • Ipswich Hospital
    Ipswich, IP4 5PD, United Kingdom
    Recruiting
    • David B Smith · Contact01473 712233
  • Leicester General Hospital
    Leicester, LE5 4PW, United Kingdom
    Recruiting
  • University Hospital South Manchester
    Manchester, M23 9LT, United Kingdom
    Recruiting
    • Rebecca Carter · Contact0161 945 8203
  • Nottingham University Hospital
    Nottingham, United Kingdom
    Recruiting
    • Donna King · Contact0115 924 9924
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05603728
Lead sponsor
Exactech
Responsible party
Sponsor
First posted
Nov 3, 2022
Start date
Jul 19, 2007
Primary completion
Dec 31, 2030 (estimated)
Completion
Dec 31, 2031 (estimated)
Last update
Sep 17, 2026

Study contacts

Rachael Craig
Contact
rachael.craig@advita.com
1-833-423-8482
Sandrine Angibaud
Contact
sandrine.angibaud@advita.com
1-833-423-8482
Jonathan Wright, MD
principal investigator · UF Health Orthopaedics and Sports Medicine Institute
Young Kwon, MD
principal investigator · Hospital for Joint Diseases - NYU Langone Health
Richard Friedman, MD
principal investigator · Charleston Orthopaedic Associates
Richard Jones, MD
principal investigator · Southeastern Orthopedics and Spine
Howard Routman, DO
principal investigator · Florida Atlantis Orthopaedics
Ryan Simovitch, MD
principal investigator · HSS
Geoffrey Abrams, MD
principal investigator · Stanford Health Care
Pierre Henri Flurin, MD
principal investigator · Centre de l'Arthrose
Harry Brownlow, MD
principal investigator · Circle Health Group
Oliver Donaldson, MD
principal investigator · Yeovil District Hospital NHS Foundation
Chris Roberts, MD
principal investigator · Ipswich Hospital
Chris Peach, MD
principal investigator · University Hospital South Manchester
Angelo Di Giunta, MD
principal investigator · Policlinico Morgagni
Alfonso Romano, MD
principal investigator · Campolongo Hospital
Sean Grey, MD
principal investigator · Orthopaedic and Spine Center of the Rockies
Chad Manke, MD
principal investigator · Altantic Orthopaedics Specialists
Rick Papandrea, MD
principal investigator · Orthopaedic Associates of Wisconsin
Andrew Chambler, MD
principal investigator · The Sulis Hospital Bath
Curt Noel, MD
principal investigator · Crystal Clinic Orthopaedic
Stephen Parada, MD
principal investigator · Orthopedic and Sports Medicine
Ari Youderian, MD
principal investigator · South County Orthopedic Specialists
Ian Byram, MD
principal investigator · Bone and Joint Institute of Tennessee
Tewfik Benkalfate, MD
principal investigator · Clinique Mutualiste la Sagesse
Peter McCann, MD
principal investigator · Lenox Health Greenwich Village
Jared Mahylis, MD
principal investigator · Henry Ford Health
Bradley Schoch, MD
principal investigator · Mayo Clinic
Stephan Pill, MD
principal investigator · Steadman Hawkins Clinic of the Carolinas
Scott Trenhaile, MD
principal investigator · OrthoIllinois
Bryan Butler, MD
principal investigator · Orthopaedic Medical Group of Tampa Bay
Ben Gooding, MD
principal investigator · Nottingham City Hospital
Brad Carofino, MD
principal investigator · Altantic Orthopaedics Specialist
Ben Sears, MD
principal investigator · Western Orthopaedics
Kenneth Faber, MD
principal investigator · St Joseph's Health Care
Jaicharan Iyengar, MD
principal investigator · Alpine Orthopaedic Medical Group
Oke Anakwenze, MD
principal investigator · Duke Department of Orthopedic Surgery
Thomas Obermeyer, MD
principal investigator · Barrington Orthopedic
Alison Armstrong, MD
principal investigator · Leicester General Hospital
George Malal, MD
principal investigator · Bedford Hospital
Diego Lima, MD
principal investigator · Florida Atlantis Orthopaedics
Remi Charvet, MD
principal investigator · Clinique Belledone
Jorn Steinbeck, MD
principal investigator · Orthopadische Praxisklinik Von Vincke
Thomas Tischer, MD
principal investigator · Malteser Waldkrankenhaus Erlangen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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