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Clinical Trial NCT07421245 for Shoulder Injuries, Shoulder Pain, Shoulder Fractures, Shoulder Arthritis, Shoulder Disease is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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OsseoFit Stemless Shoulder System (Anatomic) 136

Not yet recruiting
Clinical Trial NCT07421245 is an observational study for Shoulder Injuries, Shoulder Pain, Shoulder Fractures, Shoulder Arthritis, Shoulder Disease and is currently not yet recruiting. Enrollment is planned to begin on 1 April 2026 and continue until the study accrues 136 participants. Led by Zimmer Biomet, this study is expected to complete by 1 January 2036. The latest data from ClinicalTrials.gov was last updated on 19 February 2026.
Brief Summary
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, ...Show More
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 perfor...Show More
Official Title

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

Conditions
Shoulder InjuriesShoulder PainShoulder FracturesShoulder ArthritisShoulder Disease
Other Study IDs
  • CMU2024-23E
NCT ID Number
NCT07421245
Start Date (Actual)
2026-04
Last Update Posted
2026-02-19
Completion Date (Estimated)
2036-01
Enrollment (Estimated)
136
Study Type
Observational
Status
Not yet recruiting
Arms / Interventions
Participant Group/ArmIntervention/Treatment
OsseoFit Stemless Inlay
Subjects who were implanted with the Inlay variant of the Osseofit Stemless Shoulder System.
OsseoFit Stemless Inlay
Inlay implants have a dished superior portion with a shorter fin length to allow the implant to sit within the bone.
OsseoFit Stemless Onlay
Subjects who were implanted with the Onlay variant of the Osseofit Stemless Shoulder System.
OsseoFit Stemless Onlay
The Onlay implants sit on top of the prepared bone.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
2 years
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Implant Survival
Based on removal of any part of the study device and will be determined using Kaplan Meier method.
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.
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).
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.
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.
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
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.
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.
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.
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).
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.
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.
6 Week, 6 Month, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
20 Years
Eligible Sexes
All
  • 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.

  • 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.

  • 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)
Zimmer Biomet logoZimmer Biomet
Study Central Contact
Contact: Octavia Gladden, (704) 493-0178, [email protected]
Contact: Ryan Boylan, [email protected]
1 Study Locations in 1 Countries

New York

The Research Foundation for the State University of New York, Buffalo, New York, 14228, United States
Lin Feng, Contact, [email protected]
Thomas Duquin, MD, Principal Investigator