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出境医 / 临床实验 / MDR - Comprehensive Primary/Micro Stem & Versa-Dial Ti Humeral Head

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

Study Description
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.

Condition or disease Intervention/treatment
Shoulder Pain Shoulder Injuries Shoulder Fractures Shoulder Disease Shoulder Arthritis Device: Comprehensive Primary Micro Stem

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.

Study Design
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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
Arms and Interventions
Group/Cohort Intervention/treatment
Comprehensive Primary Micro Stem
Patients that have been implanted with the Comprehensive Primary Micro Stem to repair shoulder malfunction/disease.
Device: Comprehensive Primary Micro Stem
Patient that have been implanted with the comprehensive primary micro stem to repair shoulder malfunction/disease

Outcome Measures
Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Device Performance and Benefits evaluated through the Oxford Shoulder Score outcome measure. [ 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), through the use of the Oxford Shoulder Score (OSS). The OSS is a 12 item questionnaire, each with 5 potential answers. Patients rate their symptoms from 1 (minimal symptoms) to 5 (severe symptoms). The combined total gives a minimum score of 12 and a maximum of 60. Higher scores in the OSS imply worse functionality.

  2. Device Performance and Benefits 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), through the use of the Patient Assessment Questionnaire where adverse events and/or complications (yes or no), patient's activity level with regard to operative side, based on the UCLA Activity Score(wholly inactive 10, mostly inactive 9, sometimes participates in mild activities 8, regularly participates in mild activities 7, sometimes participates in moderate activities 6, regularly participates in moderate activities 5, regularly participates in active events 4, regularly participates in very active events 3, sometimes participates in impact sports 2, regularly participates in impact sports 1, or not recorded), and the Reported Score if Individual Scores are not available of the Oxford Shoulder Score. The UCLA Activity score rating is from 10 being the best outcome score, and 1 being the worst.


Eligibility Criteria
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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
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.
Criteria

Inclusion Criteria:

  • Patient must be 18 years of age or older.

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:

  • 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

Contacts and Locations

Locations
Layout table for location information
United States, Michigan
Beaumont Health
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
Zimmer Biomet
Investigators
Layout table for investigator information
Study Director: Kacy Arnold Zimmer Biomet
Tracking Information
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
 (submitted: June 26, 2019)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 28, 2020)
  • Device Performance and Benefits evaluated through the Oxford Shoulder Score outcome measure. [ 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), through the use of the Oxford Shoulder Score (OSS). The OSS is a 12 item questionnaire, each with 5 potential answers. Patients rate their symptoms from 1 (minimal symptoms) to 5 (severe symptoms). The combined total gives a minimum score of 12 and a maximum of 60. Higher scores in the OSS imply worse functionality.
  • Device Performance and Benefits 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), through the use of the Patient Assessment Questionnaire where adverse events and/or complications (yes or no), patient's activity level with regard to operative side, based on the UCLA Activity Score(wholly inactive 10, mostly inactive 9, sometimes participates in mild activities 8, regularly participates in mild activities 7, sometimes participates in moderate activities 6, regularly participates in moderate activities 5, regularly participates in active events 4, regularly participates in very active events 3, sometimes participates in impact sports 2, regularly participates in impact sports 1, or not recorded), and the Reported Score if Individual Scores are not available of the Oxford Shoulder Score. The UCLA Activity score rating is from 10 being the best outcome score, and 1 being the worst.
Original Secondary Outcome Measures
 (submitted: June 26, 2019)
  • Device Performance and Benefits evaluated through the ASES outcome measure [ 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).
  • Device Performance and Benefits evaluated through the UCLA activity score [ 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).
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
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
  • Shoulder Pain
  • Shoulder Injuries
  • Shoulder Fractures
  • Shoulder Disease
  • Shoulder Arthritis
Intervention Device: Comprehensive Primary Micro Stem
Patient that have been implanted with the comprehensive primary micro stem to repair shoulder malfunction/disease
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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: June 26, 2019)
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 be 18 years of age or older.

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:

  • 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

Sex/Gender
Sexes Eligible for Study: All
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
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Zimmer Biomet
Study Sponsor Zimmer Biomet
Collaborators Not Provided
Investigators
Study Director: Kacy Arnold Zimmer Biomet
PRS Account Zimmer Biomet
Verification Date March 2021