An observational study in Clinical Outcomes, Functional Outcomes and Radiological Outcomes, sponsored by Zimmer Biomet. Active, not recruiting at 6 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-06-15.
Sponsored by Zimmer Biomet · Observational
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.
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
-OR
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:
Exclusion Criteria:
The patient is
Total hip arthroplasty and implantation of the G7 device
Survivorship of the study device
This is assessed by removal of the study device from the patient for any reason, including failure of the device, infection, or traumatic injury.
Time frame: 5 years
Radiographic measurements of the implanted device
Standard AP radiographs of implanted hip will assess the positioning of the device as well as lucencies and other potential anomalies.
Time frame: 10 years
Frequency and incidence of adverse events for all subjects with particular focus on those related or potentially related to the device
Assessed by tracking the type of adverse event, severity and relation of the event(s) to the study device
Time frame: 10 years
Patient Physical Activity
UCLA activity score - patient self assessment
Time frame: 10 years
Patient Quality of Life
EQ-3L-5D quality of life measure - patient self assessment
Time frame: 10 years
Harris Hip Score
Harris Hip score measures pain, function, absence of deformity, and range of motion. Scores range from 0-100 with higher scores representing less dysfunction and better outcomes
Time frame: 10 years
Plan to share: Undecided
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Zimmer Biomet