Clinical trial NCT04003311: 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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Shoulder Pain
Shoulder Injuries
Shoulder Fractures
Shoulder Disease
Shoulder Arthritis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2019-07-01
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Device Safety assessed through the frequency and incidence of revisions, complications and Adverse Events
timeFrame: Out to 10 years
Secondary outcomes:
measure: Device Performance and Benefits evaluated through the Oxford Shoulder Score outcome measure.
timeFrame: Out to 10 years
measure: Device Performance and Benefits evaluated through the Patient Assessment Questionnaire.
timeFrame: Out to 10 years
Other outcomes:
Locations:
city: Boise
country: United States
facility: Shoulder Clinic of Idaho
state: Idaho
city: Royal Oak
country: United States
facility: Beaumont Health
state: Michigan
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: York
country: United States
facility: OSS Health Orthopedic Hospital
state: Pennsylvania
city: Burlington
country: United States
facility: Department of Orthopaedics & Rehabilitation The Larner College of Medicine at The University of Vermont
state: Vermont
Study officials:
affiliation: Zimmer Biomet
name: Erin Osborn
role: STUDY_DIRECTOR
References: