Traumatic Arthropathy of ShoulderPFXNCT05773352
Perform® Humeral System - Fracture Study (PFX)
An observational study of Traumatic Arthropathy of Shoulder and Fracture Humerus, run by Stryker Trauma and Extremities at 9 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Arthropathy of Shoulder, Fracture Humerus, Traumatic Arthritis
- What is being tested?
- Tornier Perform® Humeral System - Fracture
- Type of treatment
- Medical device
- How many people
- 118 participants
- Where
- 9 sitesUnited States
- Study dates
- 31 Aug 2023to 1 Sep 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 18 years or older at the time of the informed consent or the non-opposition (when applicable)
- Informed and willing to sign an informed consent form (ICF) approved by IRB or EC (when applicable)
- Willing and able to comply with the requirements of the study protocol
- Considered a candidate for shoulder arthroplasty with the device for shoulder joint disabled by:
- Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint, including humeral head fracture and displaced 3-or 4-part proximal humeral fractures
- Fracture sequelae
- Revisions where adequate fixation can be achieved, and adequate bone stock remains after final reconstruction
- Proximal humerus bone defect (reverse configuration)
Who cannot join
- Not able to comply with the study procedures based on the judgment of the assessor (e.g., cannot comprehend study questions, inability to keep scheduled assessment times)
- Patient belongs to a vulnerable group of subjects, including minor subjects, those unable to decide for themselves to participate or needing a LAR, or others who could be subject to coercion (subjects who may not be acting on their own initiative) (referred as "vulnerable subject" in the section 3.44 of the ISO 14155:2011 norm)
- Any absolute contraindications as mentioned in the device Instruction For Use (available on ifu.stryker.com)
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Tennessee Orthopaedic Alliance
Columbia, Tennessee, 38401
University of Texas/UT Health
Houston, Texas, 77030
The Center for Bone and Joint Disease
Hudson, Florida, 34667
University of Arkansas Medical Sciences
Little Rock, Arkansas, 72205
Loyola University Chicago
Maywood, Illinois, 60153
More Foundation
Phoenix, Arizona, 85023
Eisenhower Health Desert Orthopedic Center
Rancho Mirage, California, 92270
California Pacific Orthopaedics
San Francisco, California, 94118
Washington University
St Louis, Missouri, 63110
About this study
Official title: Tornier Perform® Humeral System - Fracture Study
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.
Read the detailed description
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.
- Conditions
- Traumatic Arthropathy of Shoulder, Fracture Humerus, Traumatic Arthritis, Revision of Other Devices if Sufficient Bone Stock Remains
- Being tested
- Tornier Perform® Humeral System - Fracture
- Medical subject headings
- Humeral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tornier Perform® Humeral System - FractureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Tornier Perform® Humeral System - Fracture | Commercially available convertible humeral system for anatomic and reverse shoulder arthroplasty. Receives: Device: Tornier Perform® Humeral System - Fracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 Month
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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..
Measured: 24 Month
Patient Satisfaction
Single subjective question "How satisfied are you with your shoulder?" Collected annually through 10 year visit.
Measured: 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.
Measured: 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.
Measured: 12 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start31 Aug 2023
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Sep 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Arthropathy of ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Trauma and Extremities
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rebecca Gibson, Study director, Stryker Trauma and Extremities
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773352
- Sponsor's protocol ID
- UE-01-2022
- Acronym
- PFX
- Status last verified
- Apr 2026
- First submitted
- 6 Mar 2023
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tornier Perform® Humeral System - Fracture Study
- ClinicalTrials.gov ID
- NCT05773352
- Acronym / sponsor ID
- PFX / UE-01-2022
- Conditions
- Traumatic Arthropathy of Shoulder, Fracture Humerus, Traumatic Arthritis, Revision of Other Devices if Sufficient Bone Stock Remains
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Stryker Trauma and ExtremitiesIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Sep 2034 (estimated)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tornier Perform® Humeral System - Fracture | – | Device: Tornier Perform® Humeral System - FractureCommercially available convertible humeral system for anatomic and reverse shoulder arthroplasty. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (8 listed)
- 18 years or older at the time of the informed consent or the non-opposition (when applicable)
- Informed and willing to sign an informed consent form (ICF) approved by IRB or EC (when applicable)
- Willing and able to comply with the requirements of the study protocol
- Considered a candidate for shoulder arthroplasty with the device for shoulder joint disabled by:
Key exclusion criteria (3 listed)
- Not able to comply with the study procedures based on the judgment of the assessor (e.g., cannot comprehend study questions, inability to keep scheduled assessment times)
- Patient belongs to a vulnerable group of subjects, including minor subjects, those unable to decide for themselves to participate or needing a LAR, or others who could be subject to coercion (subjects who may not be acting on their own initiative) (referred as "vulnerable subject" in the section 3.44 of the ISO 14155:2011 norm)
- Any absolute contraindications as mentioned in the device Instruction For Use (available on ifu.stryker.com)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tornier Perform® Humeral System - FractureA 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. | Device | Tornier Perform® Humeral System - Fracture |
Primary outcome
ASES Score = American Shoulder and Elbow Surgeons Score
Time frame: 24 Month
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
6 secondary outcomes
Constant Score
Time frame: 24 Month
SANE
Time frame: 24 Month
EQ-5D-5L
Time frame: 24 Month
Patient Satisfaction
Time frame: 24 Month
Radiographic Findings
Time frame: 24 Month
Tuberosity healing
Time frame: 12 Month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Gibson study director
Stryker Trauma and Extremities
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Arthropathy of Shoulder and Fracture Humerus, run by Stryker Trauma and Extremities at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ASES Score = American Shoulder and Elbow Surgeons Score (time frame: 24 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.