Osteoarthritis ShoulderPHSNCT05067543
Perform Humeral System Study
An observational study of Osteoarthritis Shoulder and Avascular Necrosis, run by Stryker Trauma and Extremities at 11 sites in 5 countries.
Trial summary
This study is an international, single arm, multicenter, prospective, non-significant risk, Post-Market Clinical Follow-up study, which is designed to collect safety and performance data at baseline, surgery, immediate post-op and annually through 10 years post-operation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis Shoulder, Avascular Necrosis, Post-traumatic Arthrosis of Other Joints, Shoulder Region
- What is being tested?
- Tornier Perform Humeral - Stem
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 11 sitesin 5 countries
- Study dates
- 12 Sep 2021to 1 Dec 2037
- 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
- Adult, Older adult
Study population: Patients intended for the total or partial replacement of the glenohumeral articulation.
Who may be able to join
- 18 years or older at the time of the informed consent or non-opposition (when applicable).
- Informed and willing to sign an informed consent form 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 using a study device.
- Meets indications for use requirements or other local, regional, or geographic specific regulatory requirements
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 patients, including minor patients, those unable to decide for themselves to participate or needing a Legally Authorized Representative (LAR), or others who could be subject to coercion (patients who may not be acting on their own initiative) (referred as "vulnerable subject" in the section 3.44 of the ISO 14155 norm).
- Active local or systemic infection, sepsis, or osteomyelitis
- Poor bone quality, where there could be considerable migration of the prothesis and/or a chance of fracture of the humerus or glenoid
- Significant injury to the brachial plexus
- Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components
Show all 11Show fewer
- Neuromuscular disease (e.g., joint neuropathy)
- Patient with known allergy to one of the product materials
- Metabolic disorders which may impair bone formation
- Patient pregnancy
- Planned for two-stage surgery
Trial locations and contacts
11 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 5 countries
United States7 sites, 5 recruiting
- Recruiting
Ohio State University
Columbus, Ohio, 43210
Kate Agan, 614-366-7598, kate.agan@osumc.edu
Julie Bishop, MD
- Recruiting
Summit Orthopedics
Eagan, Minnesota, 55121
Ned Tervola, ntervola@gmail.com
Michael Freehill, MD
- Recruiting
Baptist Healthcare
Lexington, Kentucky, 40503
Johnetta Comello, johnetta.comello@bhsi.com
Brent Morris
- Terminated
Mayo Clinic
Rochester, Minnesota, 55905
- Recruiting
University of Utah
Salt Lake City, Utah, 84108
Ashley Neese, Ashley.Neese@hsc.utah.edu
Robert Tashjian
- Recruiting
Orthopedic Institute
Sioux Falls, South Dakota, 57105
Khris Loe, kloe@ortho-i.com
Keith Baumgarten, MD
- Active, not recruiting
Washington University
St Louis, Missouri, 63110
Canada1 site
- Active, not recruiting
Roth McFarlane Hand and Upper Limb Centre
London, Ontario, N6A 4L6
United Kingdom1 site
- Active, not recruiting
Wrightington Hospital
Wigan, Lancashire, WN6 9EP
About this study
This study is an international, single arm, multicenter, prospective, non-significant risk, Post-Market Clinical Follow-up study, which is designed to collect safety and performance data at baseline, surgery, immediate post-op and annually through 10 years post-operation.
Data collected from this study will be used for purposes, including but not limited to, Post-Market Surveillance, peer-reviewed publications, education materials, regulatory submissions, and/or product development.
Read the detailed description
This study is an international, single arm, multicenter, prospective, non-significant risk, Post-Market Clinical Follow-up study. Data will be collected for the commercially available PERFORM™ Humeral System. The objective of this study is to demonstrate the safety and performance of the PERFORM™ Humeral System devices after implantation over a standard follow-up period using Patient Reported Outcome Measures related to quality of life, pain and functional improvements, safety of the implants, as well as radiographic assessments. Safety and performance measures will be evaluated throughout the patient's participation in the study.
- Conditions
- Osteoarthritis Shoulder, Avascular Necrosis, Post-traumatic Arthrosis of Other Joints, Shoulder Region, Rotator Cuff Tear Arthropathy
- Being tested
- Tornier Perform Humeral - Stem
- Medical subject headings
- Osteonecrosis, Rotator Cuff Tear Arthropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tornier Perform Humeral - StemDevice
The PERFORM Humeral System - Stem is a non-constrained prosthesis intended for the total or partial replacement of the glenohumeral articulation.
| Study group | Role | What they receive |
|---|---|---|
| Tornier Perform Humeral System - Stem | Partial or total shoulder arthroplasty using the Tornier Perform Humeral Stem. Receives: Device: Tornier Perform Humeral - Stem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to last follow-up visit in ASES scores
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: Baseline through Follow-Up visits through 24 months Post-Op
Secondary outcomes (7)
Change from Baseline to last follow-up visit in Constant Murley scores
Combination of physician-completed and patient-reported portions to assess functional state of shoulder including range of motion; total score reported out of 100 measuring where lower scores indicate less function of the evaluated shoulder
Measured: Baseline through Follow-Up visits through 10 years Post-Op
Change from Baseline to last follow-up visit in SANE scores
SANE = Single Assessment Numeric Evaluation; 1 item assessment of shoulder rating 0% to 100%
Measured: Baseline through Follow-Up visits through 10 years Post-Op
Change from Baseline to last follow-up visit in Subject Satisfaction scores
Single, subjective question measuring patient satisfaction; assessed by improved, worsened, or no change in satisfaction
Measured: Baseline through Follow-Up visits through 10 years Post-Op
Change from Baseline to last follow-up visit in EQ-5D scores
The EuroQol Five Dimensions Questionnaire (EQ-5D) questionnaire is a standardized instrument for use as a measure of quality of life. It is cognitively simple, takes only a few minutes to complete, and provides a simple descriptive profile as well as a single index value for quality of life that can be used in the clinical and economic evaluation of health care. The EQ-5D consists of a descriptive system which comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression), and a visual analog scale which measures the respondent's self-rated health on a 0-100 scale.
Measured: Baseline through Follow-Up visits through 10 years Post-Op
Number of device associated and procedure associated adverse events.
Measured: Baseline through Follow-Up visits through 10 years Post-Op
Rates of revision surgeries.
Measured: Baseline through Follow-Up visits through 10 years Post-Op
Evaluation of radiological imaging of the affected shoulder
Images will be analyzed for bone characteristics (baseline and post-op) and device migration, component breakage, and radiolucency (post-op visits only).
Measured: Baseline through Follow-Up visits through 10 years Post-Op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start12 Sep 2021
- Primary completion30 Jun 2037 (estimated)
- Study completion1 Dec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis 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
- 300 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067543
- Sponsor's protocol ID
- 20D-W-PHS-RM
- Acronym
- PHS
- Status last verified
- Aug 2026
- First submitted
- 23 Sep 2021
- 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
- Perform Humeral System Study
- ClinicalTrials.gov ID
- NCT05067543
- Acronym / sponsor ID
- PHS / 20D-W-PHS-RM
- Conditions
- Osteoarthritis Shoulder, Avascular Necrosis, Post-traumatic Arthrosis of Other Joints, Shoulder Region, Rotator Cuff Tear Arthropathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Stryker Trauma and ExtremitiesIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2021 (actual)
- Primary completion
- 30 Jun 2037 (estimated)
- Study completion
- 1 Dec 2037 (estimated)
- First posted
- 5 Oct 2021 (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, non-significant risk, Post-Market Clinical Follow-up study, which is designed to collect safety and performance data at baseline, surgery, immediate post-op and annually through 10 years post-operation.
Data collected from this study will be used for purposes, including but not limited to, Post-Market Surveillance, peer-reviewed publications, education materials, regulatory submissions, and/or product development.
Detailed description
This study is an international, single arm, multicenter, prospective, non-significant risk, Post-Market Clinical Follow-up study. Data will be collected for the commercially available PERFORM™ Humeral System. The objective of this study is to demonstrate the safety and performance of the PERFORM™ Humeral System devices after implantation over a standard follow-up period using Patient Reported Outcome Measures related to quality of life, pain and functional improvements, safety of the implants, as well as radiographic assessments. Safety and performance measures will be evaluated throughout the patient's participation in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tornier Perform Humeral System - Stem | – | Device: Tornier Perform Humeral - StemPartial or total shoulder arthroplasty using the Tornier Perform Humeral Stem. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients intended for the total or partial replacement of the glenohumeral articulation.
Key inclusion criteria (5 listed)
- 18 years or older at the time of the informed consent or non-opposition (when applicable).
- Informed and willing to sign an informed consent form 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 using a study device.
- Meets indications for use requirements or other local, regional, or geographic specific regulatory requirements
Key exclusion criteria (11 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 patients, including minor patients, those unable to decide for themselves to participate or needing a Legally Authorized Representative (LAR), or others who could be subject to coercion (patients who may not be acting on their own initiative) (referred as "vulnerable subject" in the section 3.44 of the ISO 14155 norm).
- Active local or systemic infection, sepsis, or osteomyelitis
- Poor bone quality, where there could be considerable migration of the prothesis and/or a chance of fracture of the humerus or glenoid
- Significant injury to the brachial plexus
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 - StemThe PERFORM Humeral System - Stem is a non-constrained prosthesis intended for the total or partial replacement of the glenohumeral articulation. | Device | Tornier Perform Humeral System - Stem |
Primary outcome
Change from Baseline to last follow-up visit in ASES scores
Time frame: Baseline through Follow-Up visits through 24 months Post-Op
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
7 secondary outcomes
Change from Baseline to last follow-up visit in Constant Murley scores
Time frame: Baseline through Follow-Up visits through 10 years Post-Op
Change from Baseline to last follow-up visit in SANE scores
Time frame: Baseline through Follow-Up visits through 10 years Post-Op
Change from Baseline to last follow-up visit in Subject Satisfaction scores
Time frame: Baseline through Follow-Up visits through 10 years Post-Op
Change from Baseline to last follow-up visit in EQ-5D scores
Time frame: Baseline through Follow-Up visits through 10 years Post-Op
Number of device associated and procedure associated adverse events.
Time frame: Baseline through Follow-Up visits through 10 years Post-Op
Rates of revision surgeries.
Time frame: Baseline through Follow-Up visits through 10 years Post-Op
Evaluation of radiological imaging of the affected shoulder
Time frame: Baseline through Follow-Up visits through 10 years Post-Op
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.
Rebecca Gibson study director
Stryker Trauma
11 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis Shoulder and Avascular Necrosis, run by Stryker Trauma and Extremities at 11 sites in 5 countries.
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 5 inclusion and 11 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: looking for participants now, 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 11 sites in United States, Canada, France, Switzerland, United Kingdom. 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?
Contact Amjad Uneisi (33638213703, amjad.uneisi@stryker.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline to last follow-up visit in ASES scores (time frame: Baseline through Follow-Up visits through 24 months Post-Op). 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.