Actively Recruiting
The Ace Avanteon Study - A Randomized Controled Trial
Led by Helse Møre og Romsdal HF · Updated on 2024-08-28
60
Participants Needed
1
Research Sites
218 weeks
Total Duration
On this page
Sponsors
H
Helse Møre og Romsdal HF
Lead Sponsor
S
St. Olavs Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
The Ace Avanteon Study - A Randomized Controled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 study and can follow scheduled clinical and radiographic evaluations
You will not qualify if you...
- Patients unable to provide informed consent
- Patients requiring revision hip arthroplasty
- Patients who have had previous osteotomy or osteosynthesis of femur or acetabulum
- Patients with metabolic bone disease other than osteoporosis
- Patients with inflammatory arthritis
- Patients with severe obesity affecting daily activities (BMI > 40)
- Patients with active or suspected infection
- Patients with malignancy
- Patients unable to cooperate due to language or psychosocial conditions
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Kristiansund Hospital, Møre and Romsdal Hospital Trust
Kristiansund, Møre and Romsdal, Norway, 6508
Actively Recruiting
Research Team
M
Myrthle Hoel, Nurse
CONTACT
M
Mathias Brevik, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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