Exception Cementless Hip Stem

Launched by ZIMMER BIOMET · Apr 14, 2020

Keywords

ClinConnect Summary

The Exception Cementless Hip Stem trial is studying a specific type of hip implant used during total hip replacement surgery. This study aims to determine how safe and effective the Exception Cementless femoral stem is in the long term for patients dealing with various hip conditions, such as osteoarthritis, rheumatoid arthritis, or hip fractures. The trial is currently active but not recruiting new participants.

To be eligible for this study, participants need to be over 18 years old and have specific hip issues like arthritis or fractures. However, individuals with certain health problems, such as infections or severe bone issues, cannot participate. If you were part of this study, you would be monitored for the safety and performance of the hip implant over time. It’s important to know that this study is looking at real-world outcomes after the surgery, helping to ensure that the implant works well for patients in everyday settings.

Gender

ALL

Eligibility criteria

• At the time of surgery, the inclusion criteria were based on the indications presented in the IFUs:
• • Primary or secondary osteoarthritis
• • Inflammatory impairment of the hip, rheumatoid arthritis, etc.
• • Fracture of the neck of the femur
• • Avascular necrosis of the femoral head
• • Sequelae from previous operations on the hip, osteotomies, etc.
• • Congenital hip dysplasia.
• • Patient is older than 18 years old
• • Patient had consented to the original data collection after his/her surgery
• At the time of surgery, the exclusion criteria were based on the contraindications presented in the IFUs:
• • Local or systemic infections.
• • Serious muscular, neurological or vascular deficiencies in the limb concerned.
• • Bone destruction or poor quality bone likely to affect the stability of the implant (Paget's disease, osteoporosis, etc.)
• • Any concomitant disorder likely to affect the function of the implant.
• • Allergy to one of the implant components.
• • Patients weighing more than 110 kg.
• • Patient incapable of following the recommendations of the surgeon