Condition or disease | Intervention/treatment |
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Shoulder Pain Shoulder Injuries Shoulder Fractures Shoulder Arthritis Shoulder Disease | Device: Comprehensive Reverse Versa-Dial Titanium Glenosphere |
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.
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 |
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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.
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Device: Comprehensive Reverse Versa-Dial Titanium Glenosphere
Implant used for patients with allergy to typical device material metals to repair shoulder malfunction/disease.
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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 |
Inclusion Criteria:
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:
Relative contraindications include:
United States, Kentucky | |
Norton Orthopaedic and Sports Medicine | |
Louisville, Kentucky, United States, 40241 |
Study Director: | Kacy Arnold | Zimmer Biomet |
Tracking Information | |||||||
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First Submitted Date | June 18, 2019 | ||||||
First Posted Date | July 1, 2019 | ||||||
Last Update Posted Date | March 23, 2021 | ||||||
Actual Study Start Date | October 28, 2019 | ||||||
Estimated Primary Completion Date | July 29, 2029 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures |
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.
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Original Primary Outcome Measures | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title | MDR - Comprehensive Reverse/Versa Dial Ti Glenosphere | ||||||
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 | ||||||
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. | ||||||
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 | ||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||
Biospecimen | Not Provided | ||||||
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. | ||||||
Condition |
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Intervention | Device: Comprehensive Reverse Versa-Dial Titanium Glenosphere
Implant used for patients with allergy to typical device material metals to repair shoulder malfunction/disease.
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Study Groups/Cohorts | 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.
Intervention: Device: Comprehensive Reverse Versa-Dial Titanium Glenosphere
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status | Enrolling by invitation | ||||||
Estimated Enrollment |
73 | ||||||
Original Estimated Enrollment | Same as current | ||||||
Estimated Study Completion Date | July 29, 2029 | ||||||
Estimated Primary Completion Date | July 29, 2029 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria |
Inclusion Criteria:
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:
Relative contraindications include:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number | NCT04003272 | ||||||
Other Study ID Numbers | MDRG2017-89MS-40E | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Zimmer Biomet | ||||||
Study Sponsor | Zimmer Biomet | ||||||
Collaborators | Not Provided | ||||||
Investigators |
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PRS Account | Zimmer Biomet | ||||||
Verification Date | March 2021 |