← Back to Search

Orthopedic Implant

Comprehensive Primary Micro Stem for SLAP Tears

N/A
Waitlist Available
Research Sponsored by Zimmer Biomet
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up out to 10 years
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • SLAP Tears
  • Greater Tuberosity Fractures
  • Shoulder Pain
  • Shoulder Fracture
  • Shoulder Injuries
  • Shoulder Arthritis
  • Shoulder Impingement Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~out to 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and out to 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Device Safety assessed through the frequency and incidence of revisions, complications and Adverse Events
Secondary study objectives
Device Performance and Benefits evaluated through the Oxford Shoulder Score outcome measure.
Device Performance and Benefits evaluated through the Patient Assessment Questionnaire.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Comprehensive Primary Micro StemExperimental Treatment1 Intervention
Patients that have been implanted with the Comprehensive Primary Micro Stem to repair shoulder malfunction/disease.
Group II: Comprehensive Anatomic Versa-Dial Titanium Humeral HeadsExperimental Treatment1 Intervention
Patients that have been implanted with the Comprehensive Anatomic Versa-Dial Titanium Humeral Heads to repair shoulder malfunction/disease.

Find a Location

Who is running the clinical trial?

Zimmer BiometLead Sponsor
377 Previous Clinical Trials
68,068 Total Patients Enrolled
Kacy ArnoldStudy DirectorZimmer Biomet
10 Previous Clinical Trials
1,940 Total Patients Enrolled
Erin OsbornStudy DirectorZimmer Biomet
13 Previous Clinical Trials
12,658 Total Patients Enrolled
~62 spots leftby Jul 2028
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top