MDR - Comprehensive Primary/Micro Stem & Versa-Dial Ti Humeral Head
Enrolling by invitation
Conditions studied: Shoulder Pain, Shoulder Injuries, Shoulder Fractures, Shoulder Disease, Shoulder Arthritis
In brief
The objective of this retrospective/prospective enrollment and prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Primary Micro Stem and Comprehensive Anatomic Versa-Dial Titanium Humeral Heads when used for primary and revision total shoulder arthroplasty (implants and instrumentation) at 1,3,5,7 and 10 years\*. Comprehensive Primary Micro Stem and Comprehensive Anatomic Versa-Dial Titanium Humeral Heads have been on the market since 2007, but have insufficient data to support 10 years of clinical history. Therefore, a prospective aspect to the study will be utilized in order to collect long-term data.
Key facts
- Study ID
- NCT04003311
- Run by
- Zimmer Biomet
- People needed
- 146
- Starts
- 2019-12-13
- Expected to finish
- 2028-07-29
- Last updated by the study team
- 2025-10-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Study devices must have been implanted following the surgical technique and IFU for the Comprehensive Micro Stem and/or the Comprehensive Anatomic Versa-Dial Humeral Heads
- Patient must be 18 years of age or older.
- Patient must have undergone a primary or revision shoulder arthroplasty with the Comprehensive Micro Stem and/or the Comprehensive Anatomic Versa-Dial Humeral Heads for a cleared indication. Cleared indications include the following:
- non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
- rheumatoid arthritis,
- revision where other devices or treatments have failed,
- correction of functional deformity,
- fractures of the proximal humerus where other methods of treatment are deemed inadequate,
- difficult clinical management problems including cuff arthroplasty where other treatment methods may not be suitable or may be inadequate.
You may not qualify if…
- Absolute contraindications include infection, sepsis, and osteomyelitis.
- Relative contraindications include:
- Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions
- Osteoporosis
- Metabolic disorders which may impair bone formation
- Osteomalacia
- Distant foci of infections which may spread to the implant site
- Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
- Patient is a prisoner.
- Patient is a current alcohol or drug abuser.
- Patient is known to be pregnant or breastfeeding.
- Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent.
Where it is running
- Shoulder Clinic of Idaho — Boise, Idaho, United States
- Beaumont Health — Royal Oak, Michigan, United States
- University of Rochester — Rochester, New York, United States
- Department of Orthopaedics & Rehabilitation The Larner College of Medicine at The University of Vermont — Burlington, Vermont, United States
Full record on ClinicalTrials.gov
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