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The Ace Avanteon Study - A Randomized Controled Trial

NCT06499038 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-08-28

No results posted yet for this study

Summary

The goal of this randomized controled trial is to compare if using of ancillary screws yields equal results as no use of ancillary screws in the ACE acetabulum cup of a total hip arthroplasty. Further, the migration of the Avanteon stem over time will be assessed. Patients included are patients with hip osteoarthritis from 65-80 years old. The purpose of this study is to compare implant migration and early fixation of a hybrid hip replacement combining the uncemented ACE acetabular component and the cemented Avanteon femoral stem, by using CT based Radiostereometric Analysis, a new innovative method for evaluating implant migration. Our study may predict the long term survival of the implants used.

Participants will go through total hip arthroplasty, and be followed by CT-RSA, plain x-rays and patients reported outcome measures.

Conditions

  • Hip Osteoarthritis

Interventions

PROCEDURE

Total Hip Arthroplasty

Surgery for total hip replacement

Sponsors & Collaborators

  • St. Olavs Hospital

    collaborator OTHER

  • JRI Orthopaedics Ltd

    collaborator INDUSTRY

  • Helse Møre og Romsdal HF

    lead OTHER_GOV

Principal Investigators

  • Frank-David Øhrn, MD, PhD · Møre og Romsdal Hospital Trust

  • Mathias Brevik, MD · Møre og Romsdal Hospital Trust

  • Otto Schnell Husby, Professor · Norwegian University of Science and Technology

  • Kirsti Sevaldsen, MD, PHD · Møre og Romsdal Hospital Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-08-25
Primary Completion
2027-06-01
Completion
2028-11-01

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 NCT06499038 on ClinicalTrials.gov