MDR - Comprehensive Primary Revision Stems PMCF

Part of paid clinical trials in Los Angeles, California.

Sponsor
Zimmer Biomet
Study ID
NCT06788717
Status
Enrolling By Invitation

Conditions

  • Shoulder Arthritis
  • Shoulder Disease
  • Shoulder Fractures
  • Shoulder Injuries
  • Shoulder Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Comprehensive Primary Revision Stems — DEVICE
    Comprehensive Primary Revision Stem (implants and instrumentation) when used for shoulder arthroplasty.

Study Details

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.

Key Dates

First listed
Jan 23, 2025
Start date
Jun 19, 2025
Status verified
Jul 2026
Primary completion
Jul 31, 2035
Completion
Dec 31, 2040

Study Design

Enrollment
59 participants (estimated)

Arms

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

Primary Outcome Measure

Implant Survivorship at 10 years follow-up (Kaplan Meier) [ Time Frame: 10 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars Sinai Medical CenterLos AngelesCalifornia900033-

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By research site
Cedars Sinai Medical Center· Los Angeles, CA

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