NCT03409718

Brief Summary

This study is a retrieval of database information regarding survivorship of the Comprehensive Shoulder System family of products. The primary objective of the retrieval is to collect data that will contribute to the post market surveillance requirements for this product and will provide feedback to design engineers, support marketing efforts and publications, and answer potential questions form reimbursement agencies.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Feb 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Feb 2011Dec 2026

Study Start

First participant enrolled

February 24, 2011

Completed
6.9 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

October 30, 2025

Status Verified

October 1, 2025

Enrollment Period

14.9 years

First QC Date

January 18, 2018

Last Update Submit

October 28, 2025

Conditions

Osteoarthritis of the ShoulderAvascular NecrosisRheumatoid ArthritisPrior Failed RevisionCorrection of Functional DeformityFracture of Proximal End of HumerusCuff Tear Arthropathy

Keywords

Total Shoulder ArthroplastyMedical DevicePerformanceSafetyShoulder Prosthesis

Outcome Measures

Primary Outcomes (1)

  • Implant survivorship is assessed counting the number of implant revisions

    Implant survivorship will be documented by assessing the number of implant revisions occurring throughout the course of the study.

    10 years

Secondary Outcomes (3)

  • Constant Shoulder Score

    10 years

  • Clinical Safety

    10 years

  • Clinical Safety - Device Related

    10 years

Study Arms (1)

Biomet Comprehensive Shoulder System

Subjects in need of a total shoulder arthroplasty who met the inclusion/exclusion criteria and received the Comprehensive Shoulder System.

Device: Biomet Comprehensive Shoulder System

Interventions

Biomet Comprehensive Shoulder SystemDEVICE

Total shoulder system designed to provide intraoperative flexibility for surgeons with unmatched humeral stem options, and infinite humeral head offset possibilities while meeting the growing demand for ease of glenoid preparation through a streamlined, low-profile, cannulated instrument platform

Biomet Comprehensive Shoulder System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in need of a total shoulder arthroplasty which receive one of the devices in the Comprehensive Shoulder family and who meet all of the inclusion and none of the exclusion criteria.

You may qualify if:

  • Must have one of the following indications:
  • 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 arthropathy, where other methods of treatment may not be suitable or may be inadequate.
  • Need to obtain pain relief and improve function
  • Ability and willingness of the patient to follow instructions, including control of weight and activity level
  • A good nutritional state of the patient
  • The patient must have reached full skeletal maturity

You may not qualify if:

  • Absolute contraindications include infection, sepsis, and osteomyelitis.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acromion LLC

Towson, Maryland, 21204, United States

Location

MeSH Terms

Conditions

OsteonecrosisArthritis, RheumatoidRotator Cuff Tear Arthropathy

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsArthritisJoint DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesChondrocalcinosisCrystal Arthropathies

Study Officials

  • Erin D Osborn

    Zimmer Biomet

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2018

First Posted

January 24, 2018

Study Start

February 24, 2011

Primary Completion

February 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

October 30, 2025

Record last verified: 2025-10

Locations

US(1)