DEXA Bone Density Analysis of the CoreHip® Prosthesis System

Launched by AESCULAP AG · Oct 7, 2024

Keywords

ClinConnect Summary

The clinical trial titled "DEXA Bone Density Analysis of the CoreHip® Prosthesis System" is designed to study how the CoreHip® hip implant affects bone density over a two-year period after surgery. Researchers will use a special scan called DEXA to measure changes in bone density in specific areas of the hip to see how well the implant is working for people with various hip conditions, such as arthritis and cartilage degeneration.

To be eligible to participate in this study, individuals should be between 35 and 85 years old and have osteoarthritis in one hip that requires surgery with the CoreHip® implant. Participants must also be able to follow the study doctor’s instructions and attend follow-up visits after their surgery. However, people with certain conditions, like severe obesity, previous hip fractures, or certain other bone diseases, will not be able to join the study. If you choose to participate, you can expect to have regular check-ins to monitor your recovery and the health of your hip implant over time.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Unilateral hip osteoarthritis
• • Indication for CoreHip Standard hip stem according to preoperative planning
• • Written Informed Consent
• • Age 35-85 years
• • According to the assessment of the study doctor, the patient is therapy compliant and able to attend the follow-up visits
• Exclusion Criteria:
• • Femoral neck fractures
• • Pregnancy
• • BMI \> 35
• • History of femoral fracture or previous surgery on the same hip
• • Metabolic bone disease, use of steroids or other drugs affecting bone metabolism
• • Intraoperative bone cracks
• • Severe osteoarthritis of the contralateral hip
• • THA of the contralateral side or other event leading to restricted weight bearing during the study period