Polarstem Versus Corail; a Comparison of Micromotion and Periprosthetic Bone Remodelling of Two Femoral Stems

Launched by HELSE-BERGEN HF · Apr 14, 2023

Keywords

ClinConnect Summary

This clinical trial is comparing two different types of femoral stems used in hip replacement surgeries for patients with arthritis and other hip conditions. The goal is to see how well a new stem, called Polarstem, performs compared to a well-established stem known as Corail. A total of 60 patients will participate, and they will be randomly assigned to receive either the Polarstem or the Corail stem. Throughout the study, researchers will monitor how much the stems move and how well the surrounding bone adjusts to the implant. Participants will also be asked about their satisfaction and how well they function after the surgery.

To be eligible for this trial, patients should have conditions like primary or secondary arthritis, or issues like a hip fracture. However, those with certain health problems, such as active cancer, severe obesity, or uncontrolled diabetes, will not be included. Patients can expect regular check-ups to assess their recovery, and the study will also use information from a national registry to understand the long-term success of the implants. This research is important as it may help determine the best options for hip replacement surgeries in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • primary arthritis
• • secondary arthritis
• • aseptic necrosis of the femoral head
• • acute hip fracture
• • sequelae after hip fracture
• • can use standard implants
• Exclusion Criteria:
• • active malignant disease
• • rheumatoid arthritis or other generalised auto-immune arthritic disease
• • BMI\>35
• • insulin dependent diabetes mellitus
• • chronic or recurrent infection
• • liver disease
• • Pagets disease
• • dementia or lack of compliance for other reasons
• • uncompensated cardiac- or pulmonary disease (ASA class 3 or 4)