N/A
N=52
Anatomical Shoulder™ Fracture PMCF Study
Fracture
Bottom Line
View on ClinicalTrials.gov: NCT02465398 ↗Enrolled (actual)
52
Serious AEs
38.5%
Results posted
Jun 2025
Primary outcome: Primary: Functional Performance — 57.7 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fracture Shoulder Arthroplasty (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zimmer Biomet
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Functional Performance |
57.7 | — |
Summary
The purpose of this study is to obtain outcomes data on the Anatomical Shoulder Fracture System by analysis of standard scoring systems and radiographs.
Outcome data will be collected using the following standard scoring systems:
- Constant and Murley Score
Eligibility Criteria
Inclusion Criteria
- Age - 18 years minimum.
- Sex - male and female.
- General Health - the patient should be able to undergo surgery and participate in a follow-up program based upon physical examination and medical history.
- Informed Consent - patient or patient's legal representative has signed a 'Patient Informed Consent form'.
- Indications - Diagnosis of trauma in the affected joint with the indication for shoulder hemiarthroplasty.
Exclusion Criteria
- Patient is skeletally immature.
- Patient is pregnant.
- Patient is unwilling or unable to cooperate in a follow-up program.
- Patient is planned for a bilateral shoulder replacement.
- Patient shows one or more of the following medical conditions:
- Pathological Fracture
- Active Infection
- Patient requires one or more of the following medical interventions:
- Revision surgery (non-union)
- Inverse fracture prosthesis
Data sourced from ClinicalTrials.gov (NCT02465398). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.