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

Shoulder Pain Clinical Trial

Official title:

Comprehensive® Primary Micro Stem and Comprehensive® Anatomic Versa-Dial Titanium Humeral Heads in Primary and Revision Total Shoulder Arthroplasty

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04003311
• Other study ID #: MDRG2017-89MS-46E
• Status: Enrolling by invitation
• Start date: December 13, 2019
• Est. completion date: July 29, 2028

Study information

• Verified date: December 2023
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 146
• Est. completion date: July 29, 2028
• Est. primary completion date: July 29, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Shoulder Arthritis
• Shoulder Disease
• Shoulder Fractures
• Shoulder Injuries
• Shoulder Pain

Intervention

Device:
• 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 Head
Patients that have been implanted with the Comprehensive Anatomic Versa-Dial Titanium Humeral head to repair shoulder malfunction/disease.

Locations

Country	Name	City	State
United States	Shoulder Clinic of Idaho	Boise	Idaho
United States	Department of Orthopaedics & Rehabilitation The Larner College of Medicine at The University of Vermont	Burlington	Vermont
United States	University of Rochester	Rochester	New York
United States	Beaumont Health	Royal Oak	Michigan
United States	OSS Health Orthopedic Hospital	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device Safety assessed through the frequency and incidence of revisions, complications and Adverse Events	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.	Out to 10 years
Secondary	Device Performance and Benefits evaluated through the Oxford Shoulder Score outcome measure.	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.	Out to 10 years
Secondary	Device Performance and Benefits evaluated through the Patient Assessment Questionnaire.	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.	Out to 10 years