Tornier Perform Reversed MonoPost Shoulder Implant: Patient Follow-Up in Real World Care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multi-center, prospective, post-market follow-up study designed to monitor safety and effectiveness of the Tornier Perform Reversed MonoPost system in real-world shoulder arthroplasty. It plans to enroll about 150 subjects across up to ten sites over one year and will track imaging findings and clinical outcomes as part of routine care. The primary goal is to achieve a mean improvement of 25 points on the ASES Shoulder Score at two years compared with baseline, across two glenoid cohorts. Secondary goals include documenting postoperative complications and functional outcomes to evaluate device performance in typical clinical settings.

Why it matters

Who can join: the full rules

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

Where it's running

• Eisenhower Health
  Rancho Mirage, California, United States Recruiting
• Ohio State University
  Columbus, Ohio, United States Recruiting

Study contacts

• Study coordinator: Monica Fleeman
• Email: Monica.Fleeman@stryker.com
• Phone: 251-465-5969

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• JADE201: a first-in-human test for rheumatoid arthritis

  This first-in-human study tests a single dose of JADE201 versus placebo to see if it is safe and how it behaves in people with rheumatoid arthritis.

  Recruiting at 8 sites Phase 1 Jade Biosciences, Inc. · Sofia and 7 other locations · NCT07533955

• How genetic differences affect leflunomide response in Pakistani rheumatoid arthritis patients

  This project will test whether specific genetic variants (SNPs) predict how well leflunomide works and whether it causes side effects in Pakistani adults with rheumatoid arthritis.

  Recruiting Foundation University Islamabad · Islamabad, Punjab Province and 1 other locations · NCT07388407

• EMPHASYS cup placement with VELYS non-invasive hip navigation in total hip replacement

  This research tests whether using the VELYS non-invasive hip navigation system helps surgeons place the EMPHASYS acetabular cup more accurately during total hip replacement for people with osteoarthritis or other hip conditions.

  Recruiting at 2 sites DePuy Orthopaedics · Gainesville, Florida and 1 other locations · NCT06631638

• Assessing the KeriFlex® silicone joint implant for arthritis treatment

  This study is testing how well the KeriFlex® silicone joint implant works and is safe for people with different types of arthritis who are getting joint replacement surgery.

  Recruiting at 3 sites Keri Medical SA · Besançon and 2 other locations · NCT06546345

• Hydrogel coating to prevent infections after hip surgery

  This study is testing whether a special hydrogel coating can help prevent infections after hip surgery for people getting a new hip implant.

  Recruiting Medacta International SA · Vienna · NCT05679232

• Registry for Physica Total Knee Replacement

  This study is testing how well the Physica knee implant works for people getting total knee replacements over the next 10 years.

  Recruiting at 3 sites Limacorporate S.p.a · Rancho Mirage, California and 4 other locations · NCT03048201

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.