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Is MIO-RSA Noninferior to BIO-RSA When it Comes to Mechanical Implant Stability?

NCT06025448 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-11-07

No results posted yet for this study

Summary

This clinical trial will investigate whether metallic lateralization in reverse shoulder arthroplasty is as stable as bony lateralization during the first two postsurgical years, measured with CT-based motion analysis (CTMA).

Conditions

  • Arthroplasty Complications
  • Shoulder Osteoarthritis

Interventions

PROCEDURE

BIO-RSA

Patients will have a reversed shoulder arthroplasty with lateralization of the joint centre using bony lateralization (BIO-RSA).

PROCEDURE

MIO-RSA

Patients will have a reversed shoulder arthroplasty with lateralization of the joint centre using metallic lateralization (MIO-RSA).

Sponsors & Collaborators

  • Lovisenberg Diakonale Hospital

    lead OTHER

Principal Investigators

  • Sigbjørn Dimmen, Prof. · University of Oslo

  • Kjersti Kaul Jenssen, PhD · Lovisenberg Diaconal Hospital

  • Christian Owesen, PhD · Lovisenberg Diaconal Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-30
Primary Completion
2033-03-01
Completion
2033-03-01

Countries

  • Norway

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 NCT06025448 on ClinicalTrials.gov