The Ace Avanteon Study - A Randomized Controled Trial
ConditionHip Osteoarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-80
SponsorHelse Møre og Romsdal HF
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
• 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
Disqualifiers
• 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
Trial design
Design model
Parallel
Treatments tested in this trial
Total Hip Arthroplasty
Procedure/SurgerySurgery for total hip replacement
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Ancillary screw groupExperimental treatment 1 intervention
Group B: Without ancillary screws groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Translation
Proximal Y migration acetabular cup measured by CT-RSA
Time frame
2 yearsSecondary outcomes
1
Rotation
Rotation XYZ measured by CT-RSA
Time frame
2 years2
Migration
Anterior and axial XZ migration acetabular cup measured by CT-RSA
Time frame
2 years3
MTPM
MTPM of acetabular cup
Time frame
2 years4
Stem Tr
Subsidence of stem
Time frame
2 yearsOther outcomes
1
Difference precision
Precision CT-RSA measured by double investigations at 2 different dose levels
Time frame
3 months2
PROMs
Patient reported outcome measures like EQ-5D-5L, OHS, VAS, FJS and HOOS
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov