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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 65
Maximum Age: 80
Healthy Volunteers: f
View:

• • 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

Locations
Other Locations
Norway
Kristiansund Hospital, Møre and Romsdal Hospital Trust
RECRUITING
Kristiansund
Contact Information
Primary
Myrthle Hoel, Nurse
Myrthle.Slettvag.Hoel@helse-mr.no
71120000
Backup
Mathias Brevik, MD
mathias.fjellingsdal.brevik@helse-mr.no
71120000
Time Frame
Start Date: 2024-08-25
Estimated Completion Date: 2028-11-01
Participants
Target number of participants: 60
Treatments
Experimental: Ancillary screw group
Patients with ancillary screw fixation acetabular component
Active_comparator: Without ancillary screws group
No ancillary screws in acetabular component
Sponsors
Collaborators: St. Olavs Hospital, JRI Orthopaedics Ltd
Leads: Helse Møre og Romsdal HF

This content was sourced from clinicaltrials.gov