At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Tornier Perform Humeral - Stem (device)
- How long the study runs
- Study runs about 195 months (dates as stated)
- About the drug or intervention
- Tornier Perform Humeral - Stem — device: The PERFORM Humeral System - Stem is a non-constrained prosthesis intended for the total or partial replacement of the glenohumeral articulation.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at shoulder replacement surgery using a medical device made by Stryker Trauma and Extremities, called the Perform Humeral System. It is for adults with shoulder problems such as osteoarthritis (wear and tear of the joint), avascular necrosis (loss of blood supply to bone), arthritis after injury, or rotator cuff tear arthropathy (a type of shoulder joint damage linked to a torn rotator cuff).
Who can take part
- Adults aged 18 or over
- Willing and able to give informed consent (permission) to take part
- Able and willing to follow the study requirements
- Considered suitable for shoulder replacement surgery using the study device
- Meets the standard requirements for use of the device, including any local or regional rules
Who may not be able to
- Unable to follow study procedures, for example cannot understand the questions or keep study appointments
- Considered a vulnerable person, such as someone who cannot decide for themselves or may feel pressured to take part
- Has an active infection, sepsis (serious blood infection), or osteomyelitis (bone infection)
- Poor bone quality that could cause the implant to move or the upper arm bone or shoulder socket to break
- Serious injury to the brachial plexus (the network of nerves running from the neck to the arm)
- Not enough healthy bone in the upper arm or shoulder socket to support the implant
- Has a neuromuscular disease (a condition affecting nerves and muscles)
- Allergic to any of the materials in the device
- Has a metabolic disorder (a condition affecting how the body builds bone)
- Is pregnant
- Is planned for two-stage surgery
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 300
- Started
- 2021-09-12
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for osteoarthritis shoulder
- • Clinical study - 300 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with osteoarthritis shoulder
Where?
- • Wigan - Wrightington Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓18 years or older at the time of the agreement to take part or non-opposition (when applicable).
- ✓Informed and willing to sign an agreement to take part 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 take part
- ✗Not able to comply with the study procedures based on the judgment of the assessor (e.g. cannot comprehend study...
- ✗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...
- ✗Significant injury to the brachial plexus
- ✗Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components
See the full criteria
Where Is This Study? (1 UK site)
Wrightington Hospital
Wigan WN6 9EP, United Kingdom
How to Get in Touch
Amjad Uneisi
Sponsor contactCONTACT
Caryn Thompson
Sponsor contactCONTACT