Non-inflammatory Degenerative Joint DiseaseRhematoid ArthritisCorrection of Functional DeformityFracture of the Humeral HeadTraumatic ArthritisRevision of the Devices if Sufficient Bone Stock Remains
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
150 (estimated)
Sponsor
Stryker Trauma and Extremities · Industry
Who this trial is looking for
This trial is looking for adults who have shoulder issues and are candidates for a specific shoulder surgery. Participants will receive the Tornier Perform™ Reversed MonoPost System and will be followed up to evaluate safety and effectiveness.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years or older.
I am willing to sign an informed consent form.
I am a candidate for shoulder surgery and have a functional deltoid muscle.
I have a massive and non-repairable rotator cuff tear.
I have one of these conditions: rheumatoid arthritis, non-inflammatory degenerative joint disease, or traumatic arthritis.
I can enroll up to 1 year after my shoulder surgery.
I have pain that limits my daily activities.
You may not be able to join if
I have a metal sensitivity or contraindication to the Tornier Perform™ System.
I am participating in another clinical trial.
I am considered a vulnerable subject, such as a child or person with mental disabilities.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This study is a Multi-center, Prospective Follow-up, Non-significant risk, Post-Market Clinical Follow-Up (PMCF) study to Evaluate the Safety and Effectiveness of the Tornier Perform™ Reversed MonoPost System.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* 18 years or older at the time of the informed consent.
* Informed and willing to sign an informed consent form (ICF) approved by Institutional Review Board (IRB) or Ethics Committee (EC).
* Willing and able to comply with the requirements of the study protocol
* Considered a c…
Inclusion Criteria:
* 18 years or older at the time of the informed consent.
* Informed and willing to sign an informed consent form (ICF) approved by Institutional Review Board (IRB) or Ethics Committee (EC).
* Willing and able to comply with the requirements of the study protocol
* Considered a candidate or having received shoulder arthroplasty with the device, having a functional deltoid muscle and with massive and non-repairable rotator cuff tear with pain disabled by:
* Rheumatoid arthritis
* Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
* Correction of functional deformity
* Fracture of the Humeral Head
* Traumatic arthritis
* Revision of the devices if sufficient bone stock remains
* Enrollment occurred up to 1 year after date of surgery provided that mandatory data are accessible: including ASES, Constant, and Active ROM.
Exclusion Criteria:
* Contraindications or hypersensitivity to the use of the Tornier Perform™ Reversed MonoPost System or their components (e.g., metal sensitivity).
* Participation in the treatment period of another clinical trial during the clinical investigation.
* Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.44. Examples include any subject "with lack of or loss of autonomy due to immaturity or through mental disability, persons in nursing homes, children, impoverished
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