A 3-Arm Study on G7 Acetabular Cup With Echo BiMetric Stem in Total Hip Arthroplasty

Launched by ZIMMER BIOMET · Aug 6, 2015

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to hip replacement surgery for patients with conditions like osteoarthritis, pain, and arthritis. The trial is comparing three different options for the hip joint to see how well they work in terms of patient satisfaction, safety, and overall outcomes after surgery. Specifically, it looks at a system called the G7 Acetabular Cup used with the Echo BiMetric Stem to see how effective and safe they are for patients undergoing total hip arthroplasty, which is a surgery to replace the hip joint.

To be eligible for the study, participants need to be between 18 and 75 years old and must be suitable for a specific type of hip replacement that does not use cement. They should have conditions like osteoarthritis or developmental dysplasia of the hip. Participants will need to provide consent to join, follow post-surgery therapy, and attend follow-up appointments. It’s important to note that individuals with certain medical issues, infections, or those who might not be able to follow the study rules will not be included. If you’re considering joining, you can expect to be monitored closely throughout the process to ensure your safety and satisfaction with the new hip joint.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient is 18 to 75 years of age, inclusive.
• • Patients determined to be suitable for uncemented fixation by investigator
• • Patient is skeletally mature.
• * Patient qualifies for primary unilateral total hip arthroplasty (THA) based on physical exam and medical history including the following:
• • Osteoarthritis (OA)
• • Developmental Dysplasia without subluxation
• • Patient is willing and able to provide written informed consent.
• • Patient is willing and able to cooperate in the required post-operative therapy.
• • Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.
• Exclusion Criteria:
• The patient is:
• • A prisoner
• • Mentally incompetent or unable to understand what participation in the study entails
• • A known alcohol or drug abuser
• • Anticipated to be non-compliant.
• • The patient has a neuromuscular disorder, vascular disorder or other conditions that could contribute to prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
• • The patient has a neurologic condition in the ipsilateral or contralateral limb which affects lower limb function.
• • The patient has a diagnosed systemic disease that could affect his/her safety or the study outcome.
• • The patient is known to be pregnant.
• • The patient is unwilling or unable to give informed consent, or to comply with the follow-up program.
• • The patient has an active or latent infection in or about the affected hip joint or an infection distant from the hip joint that may spread to the hip hematogenously.
• • The patient has had previous Girdlestone procedure (resection arthroplasty) or surgical fusion of the hip to be operated.
• • The patient has insufficient bone stock to fix the component. Insufficient bone stock exists (ex: Dorr type C) in the presence of metabolic bone disease (i.e. osteoporosis), cancer, and radiation.
• • Estimated cup size smaller than 48 or stem size smaller than 7
• • The patient has known local bone tumors in the operative hip.