The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
This is a prospective multi-center clinical evaluation following recipients of the G7 Dual Mobility hip device. The primary objective is to characterize survivorship of the G7 hip at five years post-index procedure. Secondary objectives include documentation of clinical outcomes, safety and radiographic data.
This multi-center prospective follow-up study will evaluate clinical outcomes, functional outcomes, radiological outcomes and further characterize the safety profile of the G7 Dual Mobility Hip Arthroplasty System. This will be accomplished by assessing these domains using the Harris Hip Score, UCLA Activity Score, and EQ-5D-3L, obtaining and assessing radiographs and the tracking of device or procedure related adverse events. Subjects will undergo unilateral primary or revision total hip arthroplasty and will then be followed for 10 years with intervals at 6 weeks, 1-, 2-, 3- 5- and 10 years. For the 10 year visit, subjects will not be required to present in their doctor's office, but will fill out a survey. Subsequent to 10 year data collection, the subject's participation in the study will be compete.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
All patients undergoing revision hip arthroplasty, undergoing a hip arthroplasty to correct a functional deformity, patients seeking treatment for femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques, and patients with significant hip pain or functional limitations and who are at a high dislocation risk will be considered for the study. Patients may have avascular necrosis, osteo- or rheumatoid arthritis.
Patients who are undergoing revision hip arthroplasty
Patients who are undergoing total hip arthroplasty (THA) for the correction of a functional deformity
Patients in need of treatment of femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
Patients suffer from substantial pain and/or limited function, are appropriate for a primary total hip arthroplasty, considered at high risk for dislocation and have one of the following:
Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis
Decision to have a G7 Dual Mobility system implanted was made independently and prior to recruitment into study
From 18 to 80 years of age (inclusive) at time of procedure
BMI equal to or less than 35
Unilateral total hip replacement
Willing and able to comply with the study procedures
Patients undergoing total hip arthroplasty following non-union of previous surgically treated fracture.
Infection, sepsis or osteomyelitis at the affected joint
Significant osteoporosis as defined by treating surgeon
Metabolic disorders which may impair bone formation
Distant foci of infections which may spread to the implant site
Rapid joint destruction, marked bone loss or bone resorption on preoperative radiographs
Underwent contralateral THA within 12 months of planned index procedure
Contralateral THA planned within 12 months of index procedure
Vascular insufficiency, muscular atrophy at the implant site or neuromuscular disease
The patient is
A known alcohol or drug abuser
The patient has any concomitant disease which is likely to jeopardize the functioning or success of the implant
The patient is known to be pregnant
The patient has a known sensitivity or allergy to one or more of the implanted materials, inducing but not limited to chromium, cobalt, and ceramic