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Enrolling by invitation NCT04003311

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

— Observational Shoulder Pain Shoulder Injuries Shoulder Fractures Shoulder Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Comprehensive Primary Micro Stem, Comprehensive Anatomic Versa-Dial Titanium Humeral Head.
Who it may be relevant to
Registry conditions: Shoulder Pain, Shoulder Injuries, Shoulder Fractures, Shoulder Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device Comprehensive Primary Micro Stem
    Patients that have been implanted with the Comprehensive Primary Micro Stem 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.

Primary outcome measures

  • Device Safety assessed through the frequency and incidence of revisions, complications and Adverse Events [Time frame: Out to 10 years]
Secondary outcome measures (2)
  • Device Performance and Benefits evaluated through the Oxford Shoulder Score outcome measure. [Time frame: Out to 10 years]
  • Device Performance and Benefits evaluated through the Patient Assessment Questionnaire. [Time frame: Out to 10 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 4 centers
  • Shoulder Clinic of Idaho — Boise
  • Beaumont Health — Royal Oak
  • University of Rochester — Rochester
  • Department of Orthopaedics & Rehabilitation The Larner College of Medicine at The Universi — Burlington

Identifiers

NCT: NCT04003311 · MDRG2017-89MS-46E

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗