OsseoFit Stemless Shoulder System (Anatomic)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20+
SponsorZimmer Biomet
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
OsseoFit Stemless Inlay
DeviceInlay implants have a dished superior portion with a shorter fin length to allow the implant to sit within the bone.
OsseoFit Stemless Onlay
DeviceThe Onlay implants sit on top of the prepared bone.
Treatment groups
136 Participants
are divided into 2 treatment groupsGroup A: OsseoFit Stemless Inlay1 intervention
Group B: OsseoFit Stemless Onlay1 intervention
Trial outcomes
Primary outcomes
1
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 yearsSecondary outcomes
1
Implant Survival
Based on removal of any part of the study device and will be determined using Kaplan Meier method.
Time frame
10 Years2
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 Year3
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 Year4
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 YearSponsors and contacts
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Source ClinicalTrials.gov
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