An observational study in Shoulder Injuries, Shoulder Pain and Shoulder Fractures, sponsored by Zimmer Biomet. Enrolling by invitation at 2 sites in United States. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Zimmer Biomet · Observational
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.
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.
113 studies on the registry are indexed under Shoulder Fractures; 30 are open to participants now.
This study's planned enrollment of 136 is above the median of 97 across 60 observational studies indexed under Shoulder Fractures.
Browse Shoulder Fractures studies →Zimmer Biomet is the lead sponsor of 275 studies on the registry; 28 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 19 (86%) have results posted.
Compared within Shoulder Fractures, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Shoulder Injuries. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
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.
Exclusion Criteria:
Patient has any sign of infection affecting the shoulder joint or in its proximity which may spread to the implant site. This may include:
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:
Subjects who were implanted with the Inlay variant of the Osseofit Stemless Shoulder System.
Device: OsseoFit Stemless Inlay
Subjects who were implanted with the Onlay variant of the Osseofit Stemless Shoulder System.
Device: OsseoFit Stemless Onlay
Inlay implants have a dished superior portion with a shorter fin length to allow the implant to sit within the bone.
The Onlay implants sit on top of the prepared bone.
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.
Time frame: 2 years
Implant Survival
Based on removal of any part of the study device and will be determined using Kaplan Meier method.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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