Comparing the use of screws in hip replacement surgery
Migration Analysis of a Hybrid Hip Replacement Evaluating Stem and Ancillary Acetabular Screw Fixation-A Randomized Controlled CT-RSA Trial
This study is testing whether using screws in hip replacement surgery helps older patients with hip osteoarthritis have better and more stable implants compared to not using screws.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 65 Years to 80 Years |
| Sex | All |
| Sponsor | Helse Møre og Romsdal HF Government |
| Drugs / interventions | radiation |
| Locations | 1 site (Kristiansund, Møre and Romsdal) |
| Trial ID | NCT06499038 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of using ancillary screws in the ACE acetabulum cup during total hip arthroplasty compared to not using screws. It involves patients aged 65 to 80 with hip osteoarthritis who will undergo surgery and be monitored for implant migration and fixation using CT-based Radiostereometric Analysis. The study seeks to predict the long-term survival of the implants by assessing their stability over time. Participants will be followed up with imaging and patient-reported outcomes to gather comprehensive data on the procedure's success.
Who should consider this trial
Good fit: Ideal candidates are patients aged 65 to 80 with primary hip osteoarthritis requiring total hip replacement.
Not a fit: Patients who have had previous hip surgeries, severe obesity, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved longevity and durability of hip implants, reducing the need for revision surgeries.
How similar studies have performed: This approach is innovative and represents one of the first studies using CT-RSA for this purpose in Norway, indicating a novel exploration in the field.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * • 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 Criteria: * • 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 this trial is running
Kristiansund, Møre and Romsdal
- Kristiansund Hospital, Møre and Romsdal Hospital Trust — Kristiansund, Møre and Romsdal, Norway (Recruiting)
Study contacts
- Principal investigator: Mathias Brevik, MD — Møre og Romsdal Hospital Trust
- Study coordinator: Myrthle Hoel, Nurse
- Email: Myrthle.Slettvag.Hoel@helse-mr.no
- Phone: 71120000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.