An observational study in Osteoarthritis, Avascular Necrosis and Rheumatoid Arthritis, sponsored by Zimmer Biomet. Active, not recruiting at 5 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by Zimmer Biomet · Observational
This data collection project is intended to provide clinical outcomes data to engineering, marketing as well as fulfill the post market surveillance requirements of various regulatory authorities. The study will be a prospective and one-arm.
The Comprehensive® Shoulder System with Nano humeral component is a humeral prosthesis system intended for use in total or hemi shoulder arthroplasty surgery. Total shoulder arthroplasty consists of replacement of the humeral head and glenoid. Hemi-arthroplasty consists of replacement of only the humeral head.
This project is a prospective study including one-hundred and fifty (150) anatomic and hemi cases and 44 reverse shoulders collected from up to ten (10) sites. All potential study subjects will be required to participate in the Informed Consent process.
Patients in need of an uncemented shoulder arthroplasty and who meet all of the inclusion and none of the exclusion criteria.
Exclusion Criteria:
Patients receiving the Anatomic or Hemi verison of the Comprehensive Nano.
Device: Comprehensive Nano
Patients who have received the Reverse version of the Comprehensive Nano.
Device: Comprehensive Nano
Patients requiring the Comprehensive Nano shoulder system.
Survivorship
Kaplan Meier method
Time frame: 10 years
ASES Score (American Shoulder and Elbow Surgeons)
Improvement in this score from preop to 10 year follow-up. This score includes 2 scales: 1 scale for pain, from 0 to 10 where 0 stands for "no pain at all" and 10 for "pain as bad as it can be". The second scale is for the stability of the shoulder, from 0 to 10 (0 stands for "very stable" and 10 for "very unstable").
Time frame: 10 years
SANE Score (Single Assessment Numeric Evaluation)
Improvement in this score from preop to 10 year follow-up. This is a simple, single-question, patient-based shoulder function assessment tool: "How would you rate your shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?"
Time frame: 10 years
Constant-Murley Score
Improvement in this score from preop to 10 year follow-up. This is a 100-point score. Higher scores indicate a better outcome.
Time frame: 10 years
X-rays evaluated for radiolucencies, osteolysis, migration and subsidence
Standard evaluation performed on both humeral and glenoid components
Time frame: 10 years
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Zimmer Biomet