MDR - PMCF Study for RingLoc Bipolar Acetabular Cup and Endo II Femoral Heads

Launched by ZIMMER BIOMET · Jan 5, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a specific hip implant called the Echo FX Stem, used alongside the RingLoc Bipolar Acetabular Cup and Femoral Head. The goal is to understand how safe and effective this implant is for patients with various hip conditions, such as arthritis, hip fractures, and chronic hip pain, over a follow-up period of at least 10 years. Researchers will gather past medical information about patients and also monitor their progress moving forward to ensure the implant works well in the long term.

To be eligible for this study, participants must be at least 18 years old and have certain hip-related problems, like osteoarthritis or fractures that haven’t healed properly. Patients should be willing and able to provide informed consent, meaning they understand the study and agree to participate. Those with specific health issues, such as severe osteoporosis or infections, cannot join. If you decide to participate, you can expect to have your medical history reviewed and to be followed up with over the years to see how the implant performs. This study aims to provide valuable information that could help improve treatment options for future hip surgery patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient must be 18 years of age or older and skeletally mature
• * Patient must have undergone hip hemiarthroplasty surgery with the RingLoc Bipolar Acetabular Cup or Endo II Femoral Head for a cleared indication, greater than or equal to eight years previous to the date of study consent. Cleared indications for the RingLoc Bipolar and Endo II Heads include the following:
• • Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• • Rheumatoid arthritis
• • Correction of functional deformity
• • Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
• Exclusion Criteria:
• • Any medical diagnosis present at the time of surgery that, at the Investigator's discretion, could compromise the implant's survivability
• • Off-label use or not according to the approved instructions for use (IFU) of study devices
• • Revision procedures where other treatment or devices have failed
• • Uncooperative patient or patient with neurologic disorders who is incapable of following directions
• • Patient has a psychiatric illness or