Tampa, FLNCT04697004Now EnrollingIRB Ready

Arthroplasty, Replacement Clinical Trial in Tampa, FL

Access cutting-edge arthroplasty, replacement treatment through this clinical trial at a research site in Tampa. Study-provided care at no cost to qualified participants.

Sponsored by Limacorporate S.p.a

Quick Self-Assessment

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Expert Care in Tampa

Access arthroplasty, replacement specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related arthroplasty, replacement treatment provided free

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Check if you qualify for this arthroplasty, replacement clinical trial in Tampa, FL

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Tampa

    Convenient for FL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Tampa site if eligible
  4. 4Begin participation

About This Arthroplasty, Replacement Study in Tampa

The SMR Stemless Reverse is intended for total, primary shoulder joint replacement by reducing pain and restoring shoulder articular mobility function. This is a prospective, multi-center, randomized, controlled trial to demonstrate non-inferiority of the SMR Stemless Reverse to the SMR Reverse Shoulder System. Patients with joint dysfunction who continue to experience significant symptoms despite an appropriate course of non-operative management are eligible. Patients will be considered enrolled into the study when an ICF has been signed, all inclusion criteria are met and no exclusion criteria are present including intraoperative exclusion criteria, and the patient is randomized into either the SMR Stemless Reverse (investigational) group, the SMR Reverse Shoulder System (control) group or is part of the roll-in population. Enrollment is expected to take approximately 24 months.

Sponsor: Limacorporate S.p.a

Who Can Participate

Inclusion Criteria

Age ≥ 22 years of age
Skeletally mature as evident by scapula and proximal humerus closure
Candidate for primary total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder), when clinical indications based on physical exam and medical history including one or more of the following:
Arthritis with rotator cuff tear not reparable
Irreparable rotator cuff tear
Rotator cuff tear arthropathy
Severe osteoarthritis and rotator cuff deficiency or stiff shoulder
Significant glenoid or socket side bone deformed or loss
Reoccurrence of instability or a chronic shoulder dislocation
Any other medical reason that the investigator determine that subject is a good candidate for a reverse total shoulder arthroplasty

Exclusion Criteria

BMI \> 40 kg/m2
Previous contralateral shoulder surgery within 3 months of enrollment or that requires active treatment (i.e. surgery or brace)
Had surgery in the targeted shoulder within last 12 months of enrollment, except diagnostic arthroscopy without procedures
Had surgery in lower limbs (such as hip or knee) within last 6 months of enrollment
Corticosteroid injections in the ipsilateral shoulder within 3 months of enrollment
Complete deltoid muscle insufficiency
Glenoid retroversion great than 25 degrees based off a 2D axial CT scan
History of/or signs and/or symptoms of local or systemic infection including but not limited to septicemia; osteomyelitis
Neurologically confirmed nerve lesion compromising shoulder joint function
Poor meta-epiphyseal bone stock compromising stability of the implant including but not limited to humeral head fracture, iatrogenic glenoid fracture, severe osteoporosis
Metabolic disorders which may impair fixation and stability of the implant including but not limited to uncontrolled diabetes mellitus with an HbA1C \> 7.5%
Extended bone loss after previous surgery defined as: complete bone loss of greater and lesser tuberosity
Meta-epiphyseal bony defect (including large cyst)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Tampa?

Yes, this clinical trial (NCT04697004) has an active research site in Tampa, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Arthroplasty, Replacement Treatment Options in Tampa, FL

If you're searching for arthroplasty, replacement treatment options in Tampa, FL, this clinical trial (NCT04697004) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Tampa research site is actively enrolling participants for this clinical trial. You'll receive care from experienced arthroplasty, replacement specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all arthroplasty, replacement clinical trials near you to find additional studies recruiting in your area.

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