G7 Dual Mobility System Used in Total Hip Arthroplasty for the Treatment of Femoral Neck Fracture (NCT04031209) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
G7 Dual Mobility System Used in Total Hip Arthroplasty for the Treatment of Femoral Neck Fracture
South Korea275 participantsStarted 2020-01-01
Plain-language summary
This is a retrospective and prospective, multi-center, non-comparative, post market clinical follow-up study involving orthopedic surgeons skilled in THA and experienced implanting the devices included in this study.
Who can participate
Age range55 Years – 80 Years
SexALL
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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