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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04003311
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Zimmer Biomet
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Erin Osborn
Principal Investigator Affiliation Zimmer Biomet
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Shoulder Pain, Shoulder Injuries, Shoulder Fractures, Shoulder Disease, Shoulder Arthritis
Additional Details

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.

Arms & Interventions

Arms

: 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.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Shoulder Clinic of Idaho, Boise, Idaho

Status

Address

Shoulder Clinic of Idaho

Boise, Idaho, 83704

Beaumont Health, Royal Oak, Michigan

Status

Address

Beaumont Health

Royal Oak, Michigan, 48073

University of Rochester, Rochester, New York

Status

Address

University of Rochester

Rochester, New York, 14642

OSS Health Orthopedic Hospital, York, Pennsylvania

Status

Address

OSS Health Orthopedic Hospital

York, Pennsylvania, 17402

Burlington, Vermont

Status

Address

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

Burlington, Vermont, 05405

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