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

Comprehensive® Primary Micro Stem and Comprehensive® Anatomic Versa-Dial Titanium Humeral Heads in Primary and Revision Total Shoulder Arthroplasty

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Shoulder Injuries; Shoulder Pain; Shoulder Fractures; Shoulder Arthritis; Shoulder Disease
• Intervention / Treatment: Device: Comprehensive Primary Micro Stem; Device: Comprehensive Anatomic Versa-Dial Titanium Humeral Head

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.

• Study Type: Observational
• Enrollment (Estimated): 146

Contacts and Locations

Study Locations

• United States
  • Idaho
    • Boise, Idaho, United States, 83704
      • Shoulder Clinic of Idaho
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Beaumont Health
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester
  • Pennsylvania
    • York, Pennsylvania, United States, 17402
      • OSS Health Orthopedic Hospital
  • Vermont
    • Burlington, Vermont, United States, 05405
      • Department of Orthopaedics & Rehabilitation The Larner College of Medicine at The University of Vermont

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Performance and Benefits evaluated through the Oxford Shoulder Score outcome measure.	The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs), through the use of the Oxford Shoulder Score (OSS). The OSS is a 12 item questionnaire, each with 5 potential answers. Patients rate their symptoms from 1 (minimal symptoms) to 5 (severe symptoms). The combined total gives a minimum score of 12 and a maximum of 60. Higher scores in the OSS imply worse functionality.	Out to 10 years
Device Performance and Benefits evaluated through the Patient Assessment Questionnaire.	The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs), through the use of the Patient Assessment Questionnaire where adverse events and/or complications (yes or no), patient's activity level with regard to operative side, based on the UCLA Activity Score(wholly inactive 10, mostly inactive 9, sometimes participates in mild activities 8, regularly participates in mild activities 7, sometimes participates in moderate activities 6, regularly participates in moderate activities 5, regularly participates in active events 4, regularly participates in very active events 3, sometimes participates in impact sports 2, regularly participates in impact sports 1, or not recorded), and the Reported Score if Individual Scores are not available of the Oxford Shoulder Score. The UCLA Activity score rating is from 10 being the best outcome score, and 1 being the worst.	Out to 10 years

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Erin Osborn, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2019
• Primary Completion (Estimated): July 29, 2028
• Study Completion (Estimated): July 29, 2028

Study Registration Dates

• First Submitted: June 18, 2019
• First Submitted That Met QC Criteria: June 26, 2019
• First Posted (Actual): July 1, 2019

Study Record Updates

• Last Update Posted (Actual): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Fractures, Bone; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain; Shoulder Injuries; Shoulder Fractures
• Other Study ID Numbers: MDRG2017-89MS-46E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes