Condition or disease | Intervention/treatment |
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Shoulder Pain Shoulder Injuries Shoulder Fractures Shoulder Disease Shoulder Arthritis | Device: Comprehensive Primary Micro Stem |
The objective of this retrospective enrollment/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 |
Estimated Enrollment : | 70 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Comprehensive® Primary Micro Stem and Comprehensive® Anatomic Versa-Dial Titanium Humeral Heads in Primary and Revision Total Shoulder Arthroplasty |
Actual Study Start Date : | December 13, 2019 |
Estimated Primary Completion Date : | July 29, 2028 |
Estimated Study Completion Date : | July 29, 2028 |
Group/Cohort | Intervention/treatment |
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Comprehensive Primary Micro Stem
Patients that have been implanted with the Comprehensive Primary Micro Stem to repair shoulder malfunction/disease.
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Device: Comprehensive Primary Micro Stem
Patient that have been implanted with the comprehensive primary micro stem 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:
Patient must have undergone the 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:
o 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, and difficult clinical management problems including cuff arthroplasty where other treatment methods may not be suitable.
Patients must have the ability and willingness to follow instructions, including control of weight and activity levels.
Patients must have a good nutritional state. Patients must have reached full skeletal maturity and have a functional deltoid muscle.
Exclusion Criteria:
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
United States, Michigan | |
Beaumont Health | |
Royal Oak, Michigan, United States, 48073 |
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 | December 13, 2019 | ||||||
Estimated Primary Completion Date | July 29, 2028 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures |
Device Safety assessed through the frequency and incidence of revisions, complications and Adverse Events [ Time Frame: Out to 10 years ] 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.
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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 Primary/Micro Stem & Versa-Dial Ti Humeral Head | ||||||
Official Title | Comprehensive® Primary Micro Stem and Comprehensive® Anatomic Versa-Dial Titanium Humeral Heads in Primary and Revision Total Shoulder Arthroplasty | ||||||
Brief Summary | The objective of this retrospective enrollment/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 enrollment/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. |
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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 | 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. | ||||||
Condition |
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Intervention | Device: Comprehensive Primary Micro Stem
Patient that have been implanted with the comprehensive primary micro stem to repair shoulder malfunction/disease
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Study Groups/Cohorts | Comprehensive Primary Micro Stem
Patients that have been implanted with the Comprehensive Primary Micro Stem to repair shoulder malfunction/disease.
Intervention: Device: Comprehensive Primary Micro Stem
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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 |
70 | ||||||
Original Estimated Enrollment | Same as current | ||||||
Estimated Study Completion Date | July 29, 2028 | ||||||
Estimated Primary Completion Date | July 29, 2028 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria |
Inclusion Criteria:
Patient must have undergone the 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: o 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, and difficult clinical management problems including cuff arthroplasty where other treatment methods may not be suitable. Patients must have the ability and willingness to follow instructions, including control of weight and activity levels. Patients must have a good nutritional state. Patients must have reached full skeletal maturity and have a functional deltoid muscle. Exclusion Criteria:
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 |
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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 | NCT04003311 | ||||||
Other Study ID Numbers | MDRG2017-89MS-46E | ||||||
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 |