RSA - ACTIS Hip Stem

Launched by CANADIAN RADIOSTEREOMETRIC ANALYSIS NETWORK · May 6, 2021

Keywords

ClinConnect Summary

The RSA - ACTIS Hip Stem clinical trial is studying a new type of hip implant called the ACTIS femoral stem. The main goal is to see how well this implant stays in place over two years compared to other similar hip implants. Researchers will also look at how the surgical approach affects the implant's position, measure how patients feel and function after surgery, and track any complications or problems that arise.

To participate in this trial, you need to be at least 21 years old and have hip osteoarthritis that requires surgery to replace your hip. You should also be able to follow up with the research team and give informed consent. However, certain conditions may disqualify you, such as infections, serious medical issues, or previous hip surgeries. If you join the trial, you can expect regular check-ins to monitor your recovery and the performance of the implant. This study is currently active, but they are not recruiting new participants at this time.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Symptomatic osteoarthritis of the hip indicating primary total hip arthroplasty
• • Aged 21 years or older
• • Patients willing and able to comply with follow-up requirements and self-evaluations
• • Ability to give informed consent
• • Body mass index ≤45 kg/m2
• • Exclusion Criteria
• • Active or prior infection
• • Medical condition precluding major surgery
• • Medical condition with less than 2 years life expectancy
• • Overhanging pannus (for anterior approach cohort only)
• • Prior surgery of the hip involving implantation of hardware (i.e., hemiarthroplasty, internal fixation, pelvic reconstruction near the acetabulum requiring removal)
• • Skin condition on the area of incision
• • Multi-level lumbar spine fusion
• • Ankylosing spondylolithesis
• • Shortening osteotomy through the femur