MDR - Comprehensive Primary/Micro Stem & Versa-Dial Ti Humeral Head

NCT04003311 | Enrolling By Invitation FDA Device

• 1 other identifier: MDRG2017-89MS-46E
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Shoulder Pain; Shoulder Injuries; Shoulder Fractures; Shoulder Disease; Shoulder Arthritis

Outcome Measures

Primary Outcomes (1)

• Device Safety assessed through the frequency and incidence of revisions, complications and Adverse Events

  The primary objective of this study is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications, and adverse events. Relation of the events to either implant or instrumentation should be specified.

  Out to 10 years

Secondary Outcomes (2)

• Device Performance and Benefits evaluated through the Oxford Shoulder Score outcome measure.

  Out to 10 years

• Device Performance and Benefits evaluated through the Patient Assessment Questionnaire.

  Out to 10 years

Study Arms (2)

Comprehensive Primary Micro Stem

Patients that have been implanted with the Comprehensive Primary Micro Stem to repair shoulder malfunction/disease.

Device: Comprehensive Primary Micro Stem

Comprehensive Anatomic Versa-Dial Titanium Humeral Heads

Patients that have been implanted with the Comprehensive Anatomic Versa-Dial Titanium Humeral Heads to repair shoulder malfunction/disease.

Device: Comprehensive Anatomic Versa-Dial Titanium Humeral Head

Interventions

Comprehensive Primary Micro Stem DEVICE

Patients that have been implanted with the Comprehensive Primary Micro Stem to repair shoulder malfunction/disease.

Comprehensive Primary Micro Stem

Comprehensive Anatomic Versa-Dial Titanium Humeral Head DEVICE

Patients that have been implanted with the Comprehensive Anatomic Versa-Dial Titanium Humeral head to repair shoulder malfunction/disease.

Comprehensive Anatomic Versa-Dial Titanium Humeral Heads

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A consecutive series of subjects implanted with the Comprehensive Primary Micro Stem and/or the Comprehensive Anatomic Versa-Dial Titanium Humeral Heads in primary and/or revision total shoulder arthroplasty according to the approved indications.

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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (4)

Shoulder Clinic of Idaho

Boise, Idaho, 83704, United States

Location

Beaumont Health

Royal Oak, Michigan, 48073, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Department of Orthopaedics & Rehabilitation The Larner College of Medicine at The University of Vermont

Burlington, Vermont, 05405, United States

Location

MeSH Terms

Conditions

Shoulder Pain; Shoulder Injuries; Shoulder Fractures

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Fractures, Bone

Study Officials

• Erin Osborn

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: July 1, 2019
• Study Start: December 13, 2019
• Primary Completion (Estimated): July 29, 2028
• Study Completion (Estimated): July 29, 2028
• Last Updated: October 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)