MDR - Comprehensive Primary Revision Stems PMCF

Zimmer Biomet59 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Shoulder Pain Shoulder Injuries Shoulder Fractures Shoulder Disease Shoulder Arthritis

Interventions

Comprehensive Primary Revision StemsDEVICE

Comprehensive Primary Revision Stem (implants and instrumentation) when used for shoulder arthroplasty.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Locations (2)

Cedars Sinai Medical Center

Los Angeles, California, United States

RECRUITING

Aalborg University Hospital

Aalborg, Denmark

RECRUITING

Outcomes

Primary Outcomes

Implant Survivorship at 10 years follow-up (Kaplan Meier)

Based on removal or intended removal of the device and determined using the Kaplan-Meier method.

Time frame: 10 years

Frequency and Incidence of Adverse Events (Safety)

Monitoring the frequency and incidence of adverse events, serious adverse events, adverse device effects, serious adverse device effects, and unanticipated serious adverse device effects as well as device deficiencies.

Time frame: 10 years

Secondary Outcomes

Device Performance and Benefits evaluated through the Western Ontario Arthritis of the Shoulder (WOOS) outcome measure.

The secondary objective is the assessment of performance and clinical benefits by recording patient reported clinical outcome measures (PROMs), through the use of the Western Ontario Osteoarthritis of the Should Score (WOOS). The WOOS is a 19 item questionnaire. Patients rate their symptoms from no pain extreme pain. The total score is calculated where 0 is a normal healthy shoulder and 1900 is the worst possible result. WOOS% (% of raw score) can be calculated using the formula (1900 - the score)/19 and then 0% is the worst possible result and 100% is the best possible result.

Time frame: 10 years

Central Contacts

Octavia Gladden

CONTACT

7044930178 octavia.gladden@zimmerbiomet.com

Data from ClinicalTrials.gov

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