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A 2-Year Prospective Follow-up Study of the Global Unite Reverse Fracture Shoulder System for Proximal Humerus Fractures

NCT04507880 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2020-08-11

No results posted yet for this study

Summary

The objective of this study is to evaluated the efficacy and safety of the reverse total shoulder prosthesis (RTSA) for complex proximal humerus fractures. The clinical results of RTSA will be compared to clinical results from a historical cohort, that received a hemiarthroplasty of the shoulder.

Conditions

  • Shoulder Fractures

Interventions

DEVICE

Reverse Total Shoulder Arthroplasty

The RTSA (GLOBAL UNITE Reverse Fracture System) from DePuy Synthes.

DEVICE

Hemiarthroplasty

The shoulder hemiarthroplasty

Sponsors & Collaborators

  • Herlev and Gentofte Hospital

    collaborator OTHER

  • Signe Rosner Rasmussen

    lead OTHER

Principal Investigators

  • Bo S Olsen, Professor · Herlev and Gentofte Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
65 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2024-08-01
Completion
2024-08-01
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04507880 on ClinicalTrials.gov