Clinical Trials in South Korea / NCT04031209
Active, not recruiting
Observational
G7 Dual Mobility System Used in Total Hip Arthroplasty for the Treatment of Femoral Neck Fracture
NCT04031209 · tracked via the Priya Life Science South Korea tracker
Condition(s) studied
Hip Fractures
Investigational drug(s) / intervention(s)
G7 Acetabular System
G7 Acetabular System: All patients will receive G7 Acetabular System
Study 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.
Eligibility
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
Primary outcome measure(s)
- Implant dislocation rate — One year post-surgery
Dislocation is defined as the complete loss of articulation contact between two artificial joint components.
Trial sites (7)
| Facility | City | Region | Status |
|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea | |
| Hanyang University Medical Center | Seoul | South Korea | |
| Asan medical Centre | Seoul | South Korea | |
| Seoul National University Bundang Hospital | Seoul | South Korea | |
| Samsung Medical Center | Seoul | South Korea | |
| Seoul St. Mary's Hospital | Seoul | South Korea | |
| KyungHee University Medical Center | Seoul | South Korea |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04031209 on ClinicalTrials.gov ↗ ← All trials in South Korea