Osteo Arthritis ShouldersNCT05603728
Exactech Shoulder Post Market Clinical Follow-up Study
An observational study of Osteo Arthritis Shoulders and Osteonecrosis, run by Exactech at 40 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Osteo Arthritis Shoulders, Osteonecrosis, Rotator Cuff Tears
- How many people
- 20,000 participants
- Where
- 40 sitesin 6 countries
- Study dates
- 19 Jul 2007to 31 Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who meet eligibility criteria - Patients who consent to participate to return for follow-up visits out to 10 years or longer
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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)
Trial locations and contacts
40 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
40 sites in 6 countries
United States24 sites, 24 recruiting
- Recruiting
Crystal Clinic Orthopaedic
Akron, Ohio, 44333
Ginny Texter, 330-668-4040
- Recruiting
Southeastern Sports Medicine and Orthopedics
Asheville, North Carolina, 28803
Rebecca Rathbone, 828-274-4555
- Recruiting
Orthopedic and Sports Medicine
Augusta, Georgia, 30909
Elizabeth Barker, 706-223-1493
- Recruiting
Charleston Orthopaedic Associates
Charleston, South Carolina, 29414
Lisa Mock, 843-769-2000
- Recruiting
Western Orthopaedics
Denver, Colorado, 80218
Libby Mauter, 303-321-1333
- Recruiting
Henry Ford Health
Detroit, Michigan, 48067
Johnny Kasto, 800-436-7936
- Recruiting
Duke Department of Orthopedic Surgery
Durham, North Carolina, 27705
- Recruiting
Orthopaedic and Spine Center of the Rockies
Fort Collins, Colorado, 80525
Josh Orr, 940-419-7050
- Recruiting
Bone and Joint Institute of Tenessee
Franklin, Tennessee, 37067
Kristin Freeman, 615-791-2630
- Recruiting
UF Health Orthopaedics and Sports Medicine Institute
Gainesville, Florida, 32607
Aimee Struk, 352-273-7001
- Recruiting
Steadman Hawkins Clinic of the Carolinas
Greenville, South Carolina, 29615
Kyle Adams, 864-454-7422
- Recruiting
Mayo Clinic
Jacksonville, Florida, 32224
Jennnifer Wirtz, 904-953-2000
- Recruiting
South County Orthopedic Specialists
Laguna Woods, California, 92637
949-586-3200
- Recruiting
Hospital for Joint Diseases - NYU Langone Health
New York, New York, 10003
212-598-6000
- Recruiting
Lenox Health Greenwich Village
New York, New York, 10011
Johnathan Joseph, 646-665-6000
- Recruiting
Florida Atlantis Orthopedics
Palm Beach Gardens, Florida, 33410
Rachel Routman, 561-627-8500
- Recruiting
Orthopaedic Associates of Wisconsin
Pewaukee, Wisconsin, 53072
Ryann Hamm, 262-303-5055
- Recruiting
Stanford Health Care
Redwood City, California, 94063
Anna Ramakrishnan, 650-723-5643
- Recruiting
OrthoIllinois
Rockford, Illinois, 61107
Timothy Nelligan, 815-398-9491
- Recruiting
Barrington Orthpedic Specialists
Schaumburg, Illinois, 60195
- Recruiting
Alpine Orthopaedic Medical Group
Stockton, California, 95204-5508
- Recruiting
Orthopaedic Medical Group of Tampa Bay
Tampa, Florida, 33619
Kendra Richerdson, 813-684-2663
- Recruiting
Atlantic Orthopaedics Specialists
Virginia Beach, Virginia, 23320
Brice Snyder, 757-321-3300
- Recruiting
HSS Florida
West Palm Beach, Florida, 33401
Meg Ryan, 561-657-4610
United Kingdom8 sites, 8 recruiting
- Recruiting
The Sulis Hospital Bath
Bath, BA2 8SQ
Darren James, 01761 422222
- Recruiting
Bedford Hospital
Bedford, MK42 9DJ
- Recruiting
Ipswich Hospital
Ipswich, IP4 5PD
David B Smith, 01473 712233
- Recruiting
Leicester General Hospital
Leicester, LE5 4PW
- Recruiting
University Hospital South Manchester
Manchester, M23 9LT
Rebecca Carter, 0161 945 8203
- Recruiting
Nottingham University Hospital
Nottingham
Donna King, 0115 924 9924
- Recruiting
Circle Health Group
Reading, Berks, RG2 7AU
Richard Forbes, 0118 922 6888
- Recruiting
Yeovil District Hospital NHS Foundation Trust
Yeovil, Summerset, BA21 4AT
Oliver Donaldson, 01935 475122
France3 sites, 3 recruiting
- Recruiting
Clinique Belledone
Grenoble, 38000
+33 4 76 54 40 79
- Recruiting
Centre de l'arthrose
Mérignac, 33700
Diane Deplanque, 33 5 35 38 97 09
- Recruiting
Clinique Mutualiste La Sagesse
Rennes, 35043
Tewfik Benkalfate, 33 2 99 85 75 75
Germany2 sites, 2 recruiting
- Recruiting
Malteser Waldkrankenhaus Erlangen
Erlangen, 91054
+49 9131 8220
- Recruiting
Orthopadische Praxisklinik Von Vincke
Münster, 48143
+49 251 5395960
Italy2 sites, 2 recruiting
- Recruiting
Policlinico Morgagni
Catania, 95125
Gionacchino Zappulla, 39 095 238111
- Recruiting
Campolongo Hospital
Eboli, 84025
Francesco Ascione, 39 0828 348111
Canada1 site, 1 recruiting
- Recruiting
St Joseph's Health Care
London, Ontario, N6A 4V2
About this study
Official title: 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.
- Conditions
- Osteo Arthritis Shoulders, Osteonecrosis, Rotator Cuff Tears, Rotator Cuff Tear Arthropathy, Ankylosing Spondylitis, Post-traumatic Osteoarthritis
- Medical subject headings
- Osteonecrosis, Rotator Cuff Injuries, Rotator Cuff Tear Arthropathy, Spondylitis, Ankylosing, Arthritis, Rheumatoid, Fractures, Bone, Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, an average of 1 per year
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
Measured: Through study completion, an average of 1 per year
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
Measured: Through study completion, an average of 1 per year
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
Measured: Through study completion, an average of 1 per year
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
Measured: Through study completion, an average of 1 per year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start19 Jul 2007
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis ShouldersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Exactech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan Wright, MD, Principal investigator, UF Health Orthopaedics and Sports Medicine InstituteYoung Kwon, MD, Principal investigator, Hospital for Joint Diseases - NYU Langone HealthRichard Friedman, MD, Principal investigator, Charleston Orthopaedic AssociatesRichard Jones, MD, Principal investigator, Southeastern Orthopedics and SpineHoward Routman, DO, Principal investigator, Florida Atlantis OrthopaedicsRyan Simovitch, MD, Principal investigator, HSSGeoffrey Abrams, MD, Principal investigator, Stanford Health CarePierre Henri Flurin, MD, Principal investigator, Centre de l'Arthrose
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603728
- Sponsor's protocol ID
- CR09-005
- Status last verified
- Sep 2026
- First submitted
- 25 Oct 2022
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Shoulder Arthroplasty Clinical and Radiographic Outcomes
- ClinicalTrials.gov ID
- NCT05603728
- Acronym / sponsor ID
- CR09-005
- Conditions
- Osteo Arthritis Shoulders, Osteonecrosis, Rotator Cuff Tears, Rotator Cuff Tear Arthropathy, Ankylosing Spondylitis, Post-traumatic Osteoarthritis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- ExactechIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2007 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 3 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who meet eligibility criteria - Patients who consent to participate to return for follow-up visits out to 10 years or longer
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
40 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteo Arthritis Shoulders and Osteonecrosis, run by Exactech at 40 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, United Kingdom, France, Germany, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachael Craig (1-833-423-8482, rachael.craig@advita.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constant (time frame: Through study completion, an average of 1 per year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.