An observational study in Traumatic Arthropathy of Shoulder, Fracture Humerus and Traumatic Arthritis, sponsored by Stryker Trauma and Extremities. Active, not recruiting at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Stryker Trauma and Extremities · Observational
This study is an international, single arm, multicenter, prospective follow-up, non-significant risk, Post-Market Clinical Follow-up (PMCF), which is designed to collect safety and performance data on commercially available Perform® Fracture.
Data collected from this study will be used for purposes, including but not limited to, PMS, peer-reviewed publications, education materials, future regulatory submissions, and/or product development.
This is an International, single arm, multicenter, prospective follow-up, non-significant risk, Post-Market Clinical Follow-up (PMCF) study. Data will be collected for the commercially available Perform® Fracture shoulder system in both the anatomic and reversed configurations.
The primary endpoint of this study is to demonstrate decreased pain and improved subjects' shoulder functionality of daily living by achieving a mean of American Shoulder and Elbow Surgeons (ASES) shoulder score higher than 62 points, at 2-year follow-up post-operatively, regardless of configuration (anatomic or reverse).
Retrospective inclusions are allowed: preoperative, intra operative, and 6 months data can be collected retrospectively up to 12 months after the surgery date.
Secondary outcome measures include patient reported outcome measures (PROMs) and standard radiographic findings, including, but not limited to: bone erosion, device migration/subsidence, component breakage, radiolucency, and ossification.
Safety and performance data will be collected at surgery, immediate post-op, and up to 10 years post-operation. Patient Reported Outcome Measures (PROMs), device revision and Adverse Events (AEs) will be assessed annually throughout the study.
Range of Motion (ROM), strength and radiographic imaging assessments of the study shoulder will also be performed for in-person milestones visits at 6 months (radiographic imaging assessments), 1-, 2-, 5- and 10-year, post-operatively.
175 studies on the registry are indexed under Humeral Fractures; 25 are open to participants now.
This study's enrollment of 118 is above the median of 90 across 68 observational studies indexed under Humeral Fractures.
Browse Humeral Fractures studies →Stryker Trauma and Extremities is the lead sponsor of 43 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Approximately 120 subjects are to be enrolled in this clinical investigation. Subjects participating in this clinical investigation will be recruited from the investigator's standard subject population, where all subjects presenting for an anatomic or reverse shoulder arthroplasty will be evaluated for clinical investigation participation based on the eligibility criteria.
Considered a candidate for shoulder arthroplasty with the device for shoulder joint disabled by:
Exclusion Criteria:
Commercially available convertible humeral system for anatomic and reverse shoulder arthroplasty.
Device: Tornier Perform® Humeral System - Fracture
A replacement of shoulder joints for anatomic and reverse shoulder arthroplasty. A replacement of other shoulder joints devices in case of revisions if sufficient bone stock remains.
ASES Score = American Shoulder and Elbow Surgeons Score
11 items with total score reported out of 100 measuring pain and activity of patient's evaluated shoulder where lower scores indicate more pain and less function
Time frame: 24 Month
Constant Score
A score based on a 100-point scale determined by objective measurements made by the physician in the clinic and subjective values based on pain and activities of daily living reported by the patient. Collected at: 1, 2, 5, and 10 years.
Time frame: 24 Month
SANE
Single question that asks the patient to rate their shoulder on a scale from 0 to 100, where 100 is normal. Collected annually through 10 year visit.
Time frame: 24 Month
EQ-5D-5L
Consists of a 5-question measure where patients rate their health today on a 5-point scale on a 5-dimension scale and a visual analogue scale to measure overall health status. Collected annually through 10 year visit..
Time frame: 24 Month
Patient Satisfaction
Single subjective question "How satisfied are you with your shoulder?" Collected annually through 10 year visit.
Time frame: 24 Month
Radiographic Findings
X-rays will be analyzed, when sufficient information is available, for bone erosion, device migration/subsidence, component breakage, radiolucency, and ossification. X-rays will be collected at Baseline, 6 months, 1 year, 2 year, 5 year and 10 year.
Time frame: 24 Month
Tuberosity healing
Tuberosity healing (bone union) (Boileau et al., 2002, 2013, 2019) is expected to be completed post-operatively at 6 months and assessed at 6 months and up to 1 year if tuberosity healing is not achieved at 6 months.
Time frame: 12 Month
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Stryker Trauma and Extremities