Status:
RECRUITING
The Ace Avanteon Study - A Randomized Controled Trial
Lead Sponsor:
Helse Møre og Romsdal HF
Collaborating Sponsors:
St. Olavs Hospital
JRI Orthopaedics Ltd
Conditions:
Hip Osteoarthritis
Eligibility:
All Genders
65-80 years
Phase:
NA
Brief 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...
Detailed Description
Hip and knee osteoarthritis OA is one of the leading causes of disability worldwide. The lifetime risk of developing hip OA is estimated to be 25%, in people who reach the age of 85. Total hip replace...
Eligibility Criteria
Inclusion
- • 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
- • 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
Key Trial Info
Start Date :
August 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06499038
Start Date
August 25 2024
End Date
November 1 2028
Last Update
August 28 2024
Active Locations (1)
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1
Kristiansund Hospital, Møre and Romsdal Hospital Trust
Kristiansund, Møre and Romsdal, Norway, 6508