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MDR - Comprehensive Reverse/Versa Dial Ti Glenosphere

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04003272
Recruitment Status : Enrolling by invitation
First Posted : July 1, 2019
Last Update Posted : September 23, 2020
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Brief Summary:
The objective of this retrospective/prospective consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Versa-Dial Reverse Ti Glenosphere when used for primary total shoulder arthroplasty, fractures and revision total shoulder arthroplasty (implants and instrumentation) at a 1,2,3,5,7 and 10-year follow-up* to meet EU Medical Device and other regulatory requirements for post market surveillance. Because Comprehensive Reverse Ti Glenospheres have only been on the market since 2009, a prospective aspect to the study will be utilized as well in order to collect long-term data.

Condition or disease Intervention/treatment
Shoulder Pain Shoulder Injuries Shoulder Fractures Shoulder Arthritis Shoulder Disease Device: Comprehensive Reverse Versa-Dial Titanium Glenosphere

Detailed Description:

The objective of this retrospective/prospective consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Versa-Dial Reverse Ti Glenosphere when used for primary total shoulder arthroplasty, fractures and revision total shoulder arthroplasty (implants and instrumentation) at a 1,2,3,5,7 and 10-year follow-up* to meet EU Medical Device and other regulatory requirements for post market surveillance. Because Comprehensive Reverse Ti Glenospheres have only been on the market since 2009, a prospective aspect to the study will be utilized as well in order to collect long-term data.

The primary objective 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.

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Study Type : Observational
Estimated Enrollment : 73 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Comprehensive Versa-Dial Reverse Titanium (Ti) Glenosphere in Primary, Fracture and Revision Total Shoulder Arthroplasty
Actual Study Start Date : October 28, 2019
Estimated Primary Completion Date : July 29, 2029
Estimated Study Completion Date : July 29, 2029

Group/Cohort Intervention/treatment
Comprehensive Reverse Versa-Dial Titanium Glenosphere
Patients who have an allergy to typical cobalt chrome or other metal allergies had surgery to repair shoulder malfunction/disease.
Device: Comprehensive Reverse Versa-Dial Titanium Glenosphere
Implant used for patients with allergy to typical device material metals to repair shoulder malfunction/disease.




Primary Outcome Measures :
  1. Product Safety assessed through the incidence and frequency of revisions, complications and adverse events [ Time Frame: Out to 10 years ]
    The primary objective 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.


Secondary Outcome Measures :
  1. Product Clinical Benefits and Performance evaluated through the Oxford Shoulder Scale OSS or Oxford Shoulder Questionnaire. [ Time Frame: Out to10 years ]
    The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs) using the Oxford Shoulder Scale or Oxford Shoulder Questionnaire. The Scale ranges from 0-48 with 48 indicating a satisfactory joint function score. A score of 30-39 indicated moderate to mild arthritis, a score of 20-29 indicates moderate to severe arthritis and a score of 0-19 indicates severe arthritis.

  2. Product Clinical Benefits and Performance evaluated through the Patient Assessment Questionnaire [ Time Frame: Out to 10 years ]
    The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs). This will be accomplished through the use of the Patient Assessment Questionnaire where adverse events and/or complications (yes or no- if yes, an Adverse Event Report would be completed), patient's activity level with regard to operative side (wholly inactive, mostly inactive, sometimes participates in mild activities, regularly participates in mild activities, sometimes participates in moderate activities, regularly participates in moderate activities, regularly participates in active events, regularly participates in very active events, sometimes participates in impact sports, regularly participates in impact sports, or not recorded), and the Reported Score if Individual Scores are not available. (This would be the reported score of the Oxford Shoulder Scale as described above in Outcome 2).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive series of subjects implanted with the Comprehensive Versa-Dial Reverse Titanium (Ti) Glenosphere in primary, fracture and revision total shoulder arthroplasty according to the approved indications. Inclusion/exclusion criteria are identical to the indications and contraindications in the IFU.
Criteria

Inclusion Criteria:

  • Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.

Interlok™ finish humeral stems are intended for cemented use and the MacroBond™ coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

*** For the specific components, Titanium (Ti) Glenospheres are intended for patients with Cobalt Alloy material sensitivity.

Exclusion Criteria:

  • Absolute contraindications include infection, sepsis, and osteomyelitis.

Relative contraindications include:

  1. Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.
  2. Osteoporosis.
  3. Metabolic disorders which may impair bone formation.
  4. Osteomalacia.
  5. Distant foci of infections which may spread to the implant site.
  6. Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.
  7. Patient is a prisoner.
  8. Current alcohol or drug abuser.
  9. If female, patient is known to be pregnant or breastfeeding.
  10. Patient has a psychiatric illness or cognitive deficit that will not allow from proper informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04003272


Locations
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United States, Kentucky
Norton Orthopaedic and Sports Medicine
Louisville, Kentucky, United States, 40241
Sponsors and Collaborators
Zimmer Biomet
Investigators
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Study Director: Kacy Arnold Zimmer Biomet
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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT04003272    
Other Study ID Numbers: MDRG2017-89MS-40E
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: September 23, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Shoulder Pain
Shoulder Injuries
Shoulder Fractures
Joint Diseases
Musculoskeletal Diseases
Fractures, Bone
Wounds and Injuries
Arthralgia
Pain
Neurologic Manifestations