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

NCT ID: NCT04003311

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 146 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-12-13
• Study Completion Date: 2028-07-29

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.

Detailed Description

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 1,2,3,5,7 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.

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.

The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs).

*The most recent available data will be used. If any of the listed time points are not available, data will be used from last available time point and follow-up will move forward at the closest available time point.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Comprehensive Primary Micro Stem

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

Comprehensive Primary Micro Stem

Intervention Type: DEVICE

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

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.

Comprehensive Anatomic Versa-Dial Titanium Humeral Head

Intervention Type: DEVICE

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

Interventions

Comprehensive Primary Micro Stem

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

Intervention Type: DEVICE

Comprehensive Anatomic Versa-Dial Titanium Humeral Head

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erin Osborn

Role: STUDY_DIRECTOR

Zimmer Biomet

Locations

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

Countries

United States

Other Identifiers

MDRG2017-89MS-46E

Identifier Type: -

Identifier Source: org_study_id