MDR - Comprehensive Primary Revision Stems PMCF

Zimmer Biomet

Status

Not yet enrolling

Conditions

Shoulder Pain

Shoulder Injuries

Shoulder Arthritis

Shoulder Fractures

Shoulder Disease

Treatments

Device: Comprehensive Primary Revision Stems

Study type

Observational

Funder types

Industry

Identifiers

NCT06788717

MDRG2017-89MS-50E

Details and patient eligibility

About

The objective of this retrospective and prospective consecutive series PMCF (Post Market Clinical Follow Up) study is to collect long-term data confirming safety, performance and clinical benefits of the Comprehensive Primary Revision Stems (implants and instrumentation) when used for shoulder arthroplasty at 1, 3, 5, 7 and 10 years.

Full description

The safety of this device will be assessed 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 implant, instrumentation and/or procedure should be specified.

The performance will be evaluated by assessment of reported clinical outcome measures (PROMs) as well as radiographic outcomes.

Enrollment

59 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Patient must be 18 years of age or older.
Patient must be willing and able to follow directions.
Study devices must have been implanted following the surgical technique and IFU for the Comprehensive Revision Stem

Exclusion Criteria

Off-label use.
Patient is a prisoner.
Patient is a current alcohol or drug abuser.
Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent.
Patient is unwilling to sign informed consent.
Uncooperative patient or patient with neurologic disorders who are incapable of following directions.