G7 Dual Mobility System Used in Total Hip Arthroplasty for the Treatment of Femoral Neck Fracture

Launched by ZIMMER BIOMET · Jul 21, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the G7 Dual Mobility System, a type of hip implant used in total hip replacement surgery for patients with hip fractures, especially those involving the femoral neck. The goal is to gather more information about how well this system works and how patients recover after surgery. This study is open to adults aged 55 to 80 who have experienced a specific type of hip fracture that cannot be treated by other methods and are planning to receive this hip implant.

Participants in this trial will have their surgery done by experienced orthopedic surgeons and will be followed up to monitor their recovery and the performance of the implant. To join the study, individuals must be willing to attend follow-up appointments and provide informed consent, meaning they understand the study and agree to participate. However, those with certain health issues, like active infections or severe bone problems, will not be eligible to ensure their safety and the success of the procedure. Overall, this trial aims to improve treatment options for older adults with hip fractures.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 55 to 80 years of age, inclusive
• • Skeletally mature
• • Have undergo treatment or in need of primary THA treatment of non-union, femoral neck fracture, unmanageable by other techniques
• • Have G7 Dual Mobility system implanted or decision to have a G7 Dual Mobility system implanted was made independently and prior to recruitment into study
• • Willing and able to complete scheduled follow-up evaluations as described in the study protocol
• • Has participated in the Informed Consent process and is willing and able to sign an IRB/EC approved informed consent
• Exclusion Criteria:
• • Is septic, has an active infection or has osteomyelitis at the affected joint
• • Has significant osteoporosis as defined by treating surgeon
• • Has metabolic disorder(s) which may impair bone formation
• • Has osteomalacia
• • Has distant foci of infections which may spread to the implant site
• • Has rapid joint destruction, marked bone loss or bone resorption on pre-operative radiographs
• • Has vascular insufficiency, muscular atrophy at the implant site or neuromuscular disease which might jeopardize the outcome of the surgery
• • Has any concomitant disease which is likely to jeopardize the functioning or success of the implant
• • Is known to be pregnant
• • Is a prisoner, known alcohol or drug abuser or mentally incompetent or unable to understand what participation in this study entails
• • Has a known sensitively or allergy to one or more of