Shoulder InjuriesNCT07421245

OsseoFit Stemless Shoulder System (Anatomic)

An observational study of Shoulder Injuries and Shoulder Pain, run by Zimmer Biomet at 2 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 20 years and older
Conditions the study is for: Shoulder Injuries, Shoulder Pain, Shoulder Fractures
What is being tested?: OsseoFit Stemless Inlay and OsseoFit Stemless Onlay
Type of treatment: Medical device
How many people: 136 participants
Where: 2 sitesUnited States
Study dates: 23 Jul 2026to Jan 2036
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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: The OsseoFit Stemless Shoulder implants are intended for shoulder joint arthroplasty. OsseoFit™ Stemless Shoulder humeral components have a porous surface and are indicated for uncemented biological fixation applications. Compatible Glenoid components are intended to be implanted with bone cement. The porous posts may be inserted without bone cement. Compatible Comprehensive Convertible Glenoid components are intended for cementless applications with the addition of screw fixation.

Who may be able to join

Patient must be 20 years of age or older.
The patient must be anatomically and structurally suited, as evident by scapula and proximal humerus closure, to receive the implants.
Patient planned to receive OsseoFit™ anchor with uncemented fixation.
Patient planned to receive a Modular Alliance Glenoid with bone cement. The porous posts must be coated with Porous Plasma Spray (PPS) and may be inserted without bone cement.
Patient planned to receive shoulder arthroplasty due to osteoarthritis.
Patient must be able and willing to complete the protocol required follow-up schedule.
Patient must be able and willing to sign the IRB approved consent.

Who cannot join

Patient is unwilling or unable to give consent or to comply with the follow-up program.
Patient has any condition which would in the judgement of the Investigator, place the patient at undue risk or interfere with the study.
Patient is known to be pregnant or breastfeeding.
Patient is a vulnerable participant (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, and/or anticipated to be non-compliant).
Patient is uncooperative or patient with neurologic disorders who is incapable or unwilling to follow directions.
Patient has any neuromuscular disease compromising the affected limb.

Show all 20Show fewer

Patient has any sign of infection affecting the shoulder joint or in its proximity which may spread to the implant site. This may include:
Local/systemic infection
Sepsis
Osteomyelitis
Patient presents with Osteomalacia.
Patient presents with a humeral bone fracture.
Patient presents with malunion or non-union of the tuberosities of the proximal humerus.
Patient has had a previous operative shoulder prosthesis (stem or stemless).
Patient has irreparable cuff tear.
Patient presents with inadequate humeral bone, which in the opinion of the Investigator, may lead to poor implant fixation. This may include but is not limited to:
Osteoporosis
Extensive Avascular Necrosis
Rheumatoid Arthritis
Metaphyseal bony defects (including large cysts)

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States2 sites

The Research Foundation for the State University of New York
Buffalo, New York, 14228
Summit Medical Group P.A. dba Summit
Florham Park, New Jersey, 07932

Other trials in United States

About this study

Official title: OsseoFit Stemless Shoulder System (Anatomic) Post-Market Clinical Follow-up Study

The purpose of this clinical research protocol is to evaluate the safety, efficacy, and long-term outcomes of the OsseoFit Stemless Shoulder System (Anatomic) in patients with a primary diagnosis of osteoarthritis. The study aims to assess the intraoperative characteristics, postoperative complications, functional outcomes, and radiographic findings associated with the use of the stemless implant system. Ultimately, this research aims to improve patient outcomes, enhance surgical techniques, and inform clinical decision-making in the treatment of shoulder pathology.

Read the detailed description

The objectives of this study are to confirm the safety, performance, and clinical benefits of the OsseoFit Stemless Shoulder System (implants and instruments) in primary total shoulder arthroplasty (anatomic). Safety of the system will be assessed by monitoring the frequency and incidence of adverse events. The performance and clinical benefits will be evaluated by assessment of the overall pain and functional performance, survivorship, quality of life, and radiographic parameters for all enrolled study participants.

The primary endpoint is the improvement in the American Shoulder and Elbow Surgeons (ASES) Shoulder score between the pre-operative period (baseline) and 2 years of follow up.

The key secondary endpoint is the survival of the implant system at 10 years, which is based on removal of any part of the study device and will be determined using Kaplan Meier method.

The safety of the system will be assessed by monitoring the frequency and incidence of adverse events.

The secondary endpoint evaluation will also assess the overall pain/functional performance (ASES, Constant Murley Shoulder Score, and ROM), quality of life, satisfaction, and radiographic parameters of all enrolled study participants.

Conditions: Shoulder Injuries, Shoulder Pain, Shoulder Fractures, Shoulder Arthritis, Shoulder Disease
Being tested: OsseoFit Stemless Inlay, OsseoFit Stemless Onlay
Medical subject headings: Shoulder Injuries, Shoulder Pain, Shoulder Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OsseoFit Stemless InlayDevice
Inlay implants have a dished superior portion with a shorter fin length to allow the implant to sit within the bone.
OsseoFit Stemless OnlayDevice
The Onlay implants sit on top of the prepared bone.

Study groups in NCT07421245
Study group	Role	What they receive
OsseoFit Stemless Inlay		Subjects who were implanted with the Inlay variant of the Osseofit Stemless Shoulder System. Receives: Device: OsseoFit Stemless Inlay
OsseoFit Stemless Onlay		Subjects who were implanted with the Onlay variant of the Osseofit Stemless Shoulder System. Receives: Device: OsseoFit Stemless Onlay

What is being measured

The primary outcome is the main question the study is designed to answer.

the American Shoulder and Elbow Surgeons (ASES) Shoulder Score
The primary endpoint is the American Shoulder and Elbow Surgeons (ASES) Shoulder Score. Improvement from baseline to 2 years will be evaluated using the overall mean change, with effectiveness demonstrated if the mean improvement exceeds the MCID of 10.8 points. The primary endpoint analysis will use the ITT population with all available data and no imputation. Hypotheses: H0: μCFB ≤ 10.8; H1: μCFB > 10.8, where μCFB is the mean ASES change (2 years minus baseline). The MCID of 10.8 was established using the 0.5 SD distribution method based on psychometric evaluation of ASES scores from 3,667 shoulder arthroplasty patients with ≥2-year follow-up.
Measured: 2 years

Secondary outcomes (12)

Implant Survival
Based on removal of any part of the study device and will be determined using Kaplan Meier method.
Measured: 10 Years
ASES
The American Shoulder and Elbow Surgeons Shoulder Score (ASES) was designed to assess the condition of the shoulder, regardless of disease pathology. It consists of two equally weighted components: pain (50 points) and function/disability (50 points). The pain sub-score is calculated from a single question VAS tool. The function/disability sub-score is calculated from a 10 question, 4-point Likert scale. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.
Measured: 6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
Constant Murley
The Constant-Murley score (CMS) is a patient-reported outcome questionnaire that comprises outcome measures of freedom from pain (15 points), full range of function (20 points), active range of movement (40 points), and full strength (25 points). The total score is an aggregate of the individual outcome measures. The minimum score is 0 (worst outcome) and the maximum score possible is 100 points (best outcome).
Measured: 6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
EQ-5D-5L composite
The EQ-5D is a standardized instrument widely used to measure health status. It is a self-reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS).
The questionnaire includes 5 questions referring to mobility, self-care, daily/usual activities, pain/discomfort and anxiety/depression. For EQ-5D-5L, each question can be answered in five ways, indicating no, slight, moderate, severe or extreme pain. In the derived EQ-5D-5L score, the highest score is 1 and the lowest score is -0.573. Negative numbers correspond to a self-assessed health state worse than being dead.
The VAS is a vertical scale ranging from 0 ('The worst health you can imagine') to 100 ('The best health you can imagine') where the patient reports his/her self-rated health.
Measured: 6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
SANE
The Single Assessment Numerical Evaluation (SANE) score is a single point, subjective estimate of a patient's condition. The patient is asked to rate their progress and current state on a scale of 0% - 100% of normal (e.g. How would you rate your shoulder today as a percentage of normal?) with 100% being considered normal.
Measured: 6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
Patient Satisfaction
Single-item satisfaction question - How satisfied are you with your shoulder replacement (so far)? 5 answer choices: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied
Measured: 6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
Frequency and Incidence of Adverse Events (Safety)
The frequency and incidence of adverse events, serious adverse events, adverse device effects, serious adverse device effects, and unanticipated serious adverse device effects as well as device deficiencies.
Measured: 6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
Radiographic Performance [Radiolucency]
X-rays will be evaluated for radiolucency lines to show the number of subjects with radiolucency. Radiolucency refers to structures that are less dense and permit the x-ray beam to pass through them. Radiolucent structures appear dark or black in the radiographic image.
Measured: 6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
Radiographic Performance [Osteolysis]
X-rays will be evaluated for osteolysis to show the number of subjects with osteolysis. Osteolysis is a progressive condition where bone tissue is destroyed. In this process, bones lose minerals (mostly calcium), softens, degenerates and become weaker.
Measured: 6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
Radiographic Performance [Heterotopic Ossification]
X-rays will be evaluated for heterotopic ossification to show the number of subjects with heterotopic ossification. Heterotopic ossification refers to the presence of bone in soft tissue where bone normally does not exist (extraskeletal bone).
Measured: 6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
Radiographic Performance [Humeral Component Subsidence]
X-rays will be evaluated for humeral component subsidence to show the number of subjects with subsidence. Component Subsidence refers to the presence of the device component gradually sinking or caving into the bone structure.
Measured: 6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
Radiographic Performance [Humeral Component Migration]
X-rays will be evaluated for humeral component migration to show the number of subjects with migration. Component migration refers to the presence of the device component gradually moving anteriorly, posteriorly, superiorly, or inferiorly in relation to original placement.
Measured: 6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Jul 2026Jan 2036

First posted19 Feb 2026
Study start23 Jul 2026
Primary completionJan 2036 (estimated)
Study completionJan 2036 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Shoulder InjuriesStudies of the same condition, open and under way.
More trials run by Zimmer BiometThe sponsor's other registered studies.
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: Prospective
Enrolment: 136 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07421245
Sponsor's protocol ID: CMU2024-23E
Status last verified: Sep 2026
First submitted: 13 Feb 2026
Last updated: 30 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: OsseoFit Stemless Shoulder System (Anatomic) Post-Market Clinical Follow-up Study
ClinicalTrials.gov ID: NCT07421245
Acronym / sponsor ID: CMU2024-23E
Conditions: Shoulder Injuries, Shoulder Pain, Shoulder Fractures, Shoulder Arthritis, Shoulder Disease
Study type: Observational
Recruitment status: Enrolling by invitation
Enrolment: 136 participants (estimated)
Lead sponsor: Zimmer BiometIndustry (pharma, biotech, devices)
Study start: 23 Jul 2026 (actual)
Primary completion: Jan 2036 (estimated)
Study completion: Jan 2036 (estimated)
First posted: 19 Feb 2026 (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.

Detailed description

The primary endpoint is the improvement in the American Shoulder and Elbow Surgeons (ASES) Shoulder score between the pre-operative period (baseline) and 2 years of follow up.

The key secondary endpoint is the survival of the implant system at 10 years, which is based on removal of any part of the study device and will be determined using Kaplan Meier method.

The safety of the system will be assessed by monitoring the frequency and incidence of adverse events.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
OsseoFit Stemless Inlay	–	Device: OsseoFit Stemless InlaySubjects who were implanted with the Inlay variant of the Osseofit Stemless Shoulder System.
OsseoFit Stemless Onlay	–	Device: OsseoFit Stemless OnlaySubjects who were implanted with the Onlay variant of the Osseofit Stemless Shoulder System.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The OsseoFit Stemless Shoulder implants are intended for shoulder joint arthroplasty. OsseoFit™ Stemless Shoulder humeral components have a porous surface and are indicated for uncemented biological fixation applications. Compatible Glenoid components are intended to be implanted with bone cement. The porous posts may be inserted without bone cement. Compatible Comprehensive Convertible Glenoid components are intended for cementless applications with the addition of screw fixation.

Key inclusion criteria (7 listed)

Patient must be 20 years of age or older.
The patient must be anatomically and structurally suited, as evident by scapula and proximal humerus closure, to receive the implants.
Patient planned to receive OsseoFit™ anchor with uncemented fixation.
Patient planned to receive a Modular Alliance Glenoid with bone cement. The porous posts must be coated with Porous Plasma Spray (PPS) and may be inserted without bone cement.
Patient planned to receive shoulder arthroplasty due to osteoarthritis.

Key exclusion criteria (20 listed)

Patient is unwilling or unable to give consent or to comply with the follow-up program.
Patient has any condition which would in the judgement of the Investigator, place the patient at undue risk or interfere with the study.
Patient is known to be pregnant or breastfeeding.
Patient is a vulnerable participant (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, and/or anticipated to be non-compliant).
Patient is uncooperative or patient with neurologic disorders who is incapable or unwilling to follow directions.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OsseoFit Stemless InlayInlay implants have a dished superior portion with a shorter fin length to allow the implant to sit within the bone.	Device	OsseoFit Stemless Inlay
OsseoFit Stemless OnlayThe Onlay implants sit on top of the prepared bone.	Device	OsseoFit Stemless Onlay

Primary outcome

the American Shoulder and Elbow Surgeons (ASES) Shoulder Score
Time frame: 2 years
The primary endpoint is the American Shoulder and Elbow Surgeons (ASES) Shoulder Score. Improvement from baseline to 2 years will be evaluated using the overall mean change, with effectiveness demonstrated if the mean improvement exceeds the MCID of 10.8 points. The primary endpoint analysis will use the ITT population with all available data and no imputation. Hypotheses: H0: μCFB ≤ 10.8; H1: μCFB > 10.8, where μCFB is the mean ASES change (2 years minus baseline). The MCID of 10.8 was established using the 0.5 SD distribution method based on psychometric evaluation of ASES scores from 3,667 shoulder arthroplasty patients with ≥2-year follow-up.

12 secondary outcomes

Implant Survival
Time frame: 10 Years
ASES
Time frame: 6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
Constant Murley
Time frame: 6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
EQ-5D-5L composite
Time frame: 6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
SANE
Time frame: 6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
Patient Satisfaction
Time frame: 6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
Frequency and Incidence of Adverse Events (Safety)
Time frame: 6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
Radiographic Performance [Radiolucency]
Time frame: 6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
Radiographic Performance [Osteolysis]
Time frame: 6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
Radiographic Performance [Heterotopic Ossification]
Time frame: 6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
Radiographic Performance [Humeral Component Subsidence]
Time frame: 6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
Radiographic Performance [Humeral Component Migration]
Time frame: 6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year

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 30 Sep 2026.
Individual participant dataSharing planned: No

Related trials for Shoulder Injuries

Not yet recruitingObservational study
Cross-Cultural Adaptation, Validity, and Reliability of the Functional Arm Scale for Throwers (FAST) in Throwing Athletes
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Active, not recruiting
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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.

Jim Nevelos study director

Zimmer Biomet

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Shoulder Injuries and Shoulder Pain, run by Zimmer Biomet at 2 sites in United States.

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 7 inclusion and 20 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: enrolling by invitation, as of the sponsor's last update on 30 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 2 sites in United States. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the American Shoulder and Elbow Surgeons (ASES) Shoulder Score (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07421245.

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 30 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.