Patient Reported Outcome After Stemmed Versus Stemless Total Shoulder Arthroplasty for Glenohumeral Osteoarthritis.

NCT03877315 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2022-12-22

No results posted yet for this study

Summary

Stemless shoulder arthroplasty systems with uncemented metaphyseal fixation have been used in Europe for glenohumeral osteoarthritis since 2004. The stemless design has several theoretical advantages compared with the stemmed shoulder arthroplasty systems: restoring patients' anatomy, preserving humeral bone stock, and few complications in component removal if the need for a revision arthroplasty arises. The purpose of the study is to compare the short-term, patient-reported outcome of stemless and stemmed total shoulder arthroplasty.

Conditions

  • Shoulder Pain
  • Shoulder Osteoarthritis
  • Shoulder Arthritis

Interventions

DEVICE

Stemmed shoulder arthroplasty, Biomet Comprehensive® Total Shoulder System.

A total shoulder prosthesis used in treating glenohumeral osteoarthritis

DEVICE

Stemless shoulder arthroplasty, Biomet Comprehensive® Nano Shoulder System.

A total shoulder prosthesis used in treating glenohumeral osteoarthritis

Sponsors & Collaborators

  • Hvidovre University Hospital

    collaborator OTHER
  • Zealand University Hospital

    lead OTHER

Principal Investigators

  • Zaid Issa, MD · Zealand University Hospital Koege

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2022-02-28
Completion
2023-08-01

Countries

  • Denmark

Study Locations

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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 NCT03877315 on ClinicalTrials.gov