An observational study in Osteoarthritis Shoulder, Avascular Necrosis and Post-traumatic Arthrosis of Other Joints, Shoulder Region, sponsored by Stryker Trauma and Extremities. Recruiting at 11 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Stryker Trauma and Extremities (part of Stryker) · Observational
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.
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.
286 studies on the registry are indexed under Osteonecrosis; 45 are open to participants now.
This study's planned enrollment of 300 is above the median of 121 across 127 observational studies indexed under Osteonecrosis.
Browse Osteonecrosis 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.
Patients intended for the total or partial replacement of the glenohumeral articulation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Partial or total shoulder arthroplasty using the Tornier Perform Humeral Stem.
Device: Tornier Perform Humeral - Stem
The PERFORM Humeral System - Stem is a non-constrained prosthesis intended for the total or partial replacement of the glenohumeral articulation.
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
Time frame: Baseline through Follow-Up visits through 24 months Post-Op
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
Time frame: 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%
Time frame: 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
Time frame: 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.
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
Images will be analyzed for bone characteristics (baseline and post-op) and device migration, component breakage, and radiolucency (post-op visits only).
Time frame: Baseline through Follow-Up visits through 10 years Post-Op
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Plan to share: No
No publications or documents are linked to this record.
Started Sep 2021 (actual). Primary completion is estimated for Jun 2037, 189 months after the start.
Of 59 observational studies under Osteonecrosis, half reached primary completion within 141 months of starting (the median), counting those still running; a quarter within 93 and three quarters within 184. This study's planned 189 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
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