G7 Dual Mobility hip
DeviceTotal hip arthroplasty and implantation of the G7 device
NCT Number: NCT03308929
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 study is active but is not currently recruiting participants.
18 year–80 year
All sexes
Observational
Jersey City Medical Center, Jersey City, New Jersey, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-OR
Exclusion criteria
Total hip arthroplasty and implantation of the G7 device
Time frame: 5 years
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: 10 years
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
Assessed by tracking the type of adverse event, severity and relation of the event(s) to the study device
Time frame: 10 years
UCLA activity score - patient self assessment
Time frame: 10 years
EQ-3L-5D quality of life measure - patient self assessment
Time frame: 10 years
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
Zimmer Biomet
Industry
Prospective Multi-Center Clinical Evaluation Following Total Hip Arthroplasty With the G7 Dual Mobility System
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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