MDR - Comprehensive Primary Revision Stems PMCF

NCT06788717 | Recruiting FDA Device

• 1 other identifier: MDRG2017-89MS-50E
• Study Type: observational
• Target: 59
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Shoulder Pain; Shoulder Injuries; Shoulder Fractures; Shoulder Disease; Shoulder Arthritis

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  10 years

Secondary Outcomes (1)

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

  10 years

Study Arms (1)

Treatment Group

The study population will comprise a consecutive cohort of 59 cases (males and females), implanted with the Comprehensive Primary Revision Stem.

Device: Comprehensive Primary Revision Stems

Interventions

Comprehensive Primary Revision Stems DEVICE

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

Treatment Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive series of subjects implanted with the Comprehensive Primary Revision Stems according to the approved indications will be identified and invited to participate in the study.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (2)

Cedars Sinai Medical Center

Los Angeles, California, 900033, United States

RECRUITING

Aalborg University Hospital

Aalborg, DK-9000, Denmark

RECRUITING

MeSH Terms

Conditions

Shoulder Pain; Shoulder Injuries; Shoulder Fractures

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Fractures, Bone

Study Officials

• Ryan Boylan, MBA

  Zimmer Biomet

  STUDY DIRECTOR

Central Study Contacts

Octavia Gladden

CONTACT

7044930178; octavia.gladden@zimmerbiomet.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 23, 2025
• Study Start: June 19, 2025
• Primary Completion (Estimated): July 1, 2035
• Study Completion (Estimated): December 1, 2040
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

US (1); DK (1)