An interventional study of Fracture Shoulder Arthroplasty in Fracture, sponsored by Zimmer Biomet. Completed at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-12.
Sponsored by Zimmer Biomet · Not applicable, Interventional, and Treatment
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:
This is a multi-centre, non-comparative, prospective post-market surveillance study involving surgeons skilled in shoulder replacement surgery. Each case enrolled will receive an Anatomical Shoulder Fracture implant. All system components are CE (Conformité Européenne)-marked and commercially available. Patients will be selected according to the subject selection criteria.
All patients will undergo pe-operative, intra-operative and post-operative physical examination, radiographic evaluation according to the hospital's routine procedure and collection of quality of life metrics. Follow-up evaluations are to be conducted at 6-12 weeks (x-rays only), at 6 months and annually thereafter for a minimum period of 5 years post hospital discharge. Follow-up evaluation at 10 years post hospital discharge is optional.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's enrollment of 52 is below the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Zimmer Biomet is the lead sponsor of 271 studies on the registry; 28 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 19 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patient shows one or more of the following medical conditions:
Patient requires one or more of the following medical interventions:
Patient were treated with an Anatomical Shoulder Fracture device.
Procedure: Fracture Shoulder Arthroplasty
Implantation of the Anatomical Shoulder Fracture System
Functional Performance
Constant \& Murley Score. This evaluates clinical parameters such as range of motion, power, level of pain and functional ability. The score ranges from 0 - 100 with a higher score representing a better outcome.
Time frame: 5 years
| Milestone | Fracture Device |
|---|---|
| Started | 52 |
| Completed | 22 |
| Not completed | 30 |
| Withdrew: Death | 7 |
| Withdrew: Revision | 7 |
| Withdrew: Did not receive study device | 1 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Lost to follow-up | 14 |
Constant \& Murley Score. This evaluates clinical parameters such as range of motion, power, level of pain and functional ability. The score ranges from 0 - 100 with a higher score representing a better outcome.
| score on a scale | Fracture Device |
|---|---|
| Functional Performance | 57.7 ± 13.2 |
Collected over AE data was collected over the entire study from surgery date until an average of 5 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fracture Device | 7/52 (13.5%) | 20/52 (38.5%) | — |
| Event | Fracture Device |
|---|---|
| Other, not shoulder related complicationsMusculoskeletal and connective tissue disorders | 8/52 |
| Death due to unrelated reasonsGeneral disorders | 7/52 |
| Revision: conversion to reverse prosthesisSurgical and medical procedures | 6/52 |
| Frozen ShoulderMusculoskeletal and connective tissue disorders | 3/52 |
| Intraoperative fractureMusculoskeletal and connective tissue disorders | 2/52 |
| Heterotopic ossificationMusculoskeletal and connective tissue disorders | 2/52 |
| Revision: conversion to reverse prosthesisSurgical and medical procedures | 1/52 |
| Nerve deficitNervous system disorders | 1/52 |
| SubluxationMusculoskeletal and connective tissue disorders | 1/52 |
52 subjects enrolled, 51 subjects operated.
| Age, Continuous(years) | Fracture Device |
|---|---|
| Mean | 69.3 ± 10.4 |
| Sex: Female, Male(Participants) | Fracture Device |
|---|---|
| Female | 28 |
| Male | 23 |
| Race (NIH/OMB)(Participants) | Fracture Device |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 50 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Fracture Device |
|---|---|
| United Kingdom | 19 |
| Switzerland | 24 |
| Germany | 8 |
| BMI(kg/m2) | Fracture Device |
|---|---|
| Mean | 28.4 ± 8.9 |
| Height(cm) | Fracture Device |
|---|---|
| Mean | 167.6 ± 10.1 |
| Weight(kg) | Fracture Device |
|---|---|
| Mean | 79.5 ± 24.0 |
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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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