RecruitingNot ApplicableNCT06499038

The Ace Avanteon Study - A Randomized Controled Trial

Migration Analysis of a Hybrid Hip Replacement Evaluating Stem and Ancillary Acetabular Screw Fixation-A Randomized Controlled CT-RSA Trial


Sponsor

Helse Møre og Romsdal HF

Enrollment

60 participants

Start Date

Aug 25, 2024

Study Type

INTERVENTIONAL

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.


Eligibility

Min Age: 65 YearsMax Age: 80 Years

Inclusion Criteria3

  • Patients with primary hip osteoarthritis between the age of 65 and 80 years at time of surgery
  • Patients requiring primary total hip replacement
  • Patients who understand the conditions of the study, are willing to, and able to comply with the postoperative scheduled clinical and radiographic evaluations

Exclusion Criteria9

  • Patients who are unable to provide informed consent
  • Patients who require revision hip arthroplasty
  • Patients who have had a previous osteotomy or osteosynthesis of the femur or acetabulum
  • Patients with metabolic bone disease, other than osteoporosis
  • Patients with inflammatory arthritis
  • Obese patients where obesity is severe enough to affect the patient's ability to perform activities of daily living (BMI > 40)
  • Patients with active or suspected infection
  • Patients with malignancy
  • Patients unable to cooperate caused by language or psychosocial conditions

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDURETotal Hip Arthroplasty

Surgery for total hip replacement


Locations(1)

Kristiansund Hospital, Møre and Romsdal Hospital Trust

Kristiansund, Møre and Romsdal, Norway

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06499038