The Ace Avanteon Study - A Randomized Controled Trial

Recruiting now · Not applicable

Conditions studied: Hip Osteoarthritis

In brief

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.

Key facts

Study ID

NCT06499038

Run by

Helse Møre og Romsdal HF

People needed

60

Starts

2024-08-25

Expected to finish

2028-11-01

Last updated by the study team

2024-08-28

Who can join

Age: 65 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • 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

You may not qualify if…

• • 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

Where it is running

• Kristiansund Hospital, Møre and Romsdal Hospital Trust — Kristiansund, Møre and Romsdal, Norway (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.